Document text
Page 1 of 363
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option
is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895934
Page 2 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/14/2020
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895935
Page 3 of 363
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10191037]
2.Birth Date: /1947
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895936
Page 4 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/14/2020
2.Erroneous Visit
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895937
Page 5 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895938
Page 6 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895939
Page 7 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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:[Presbyopia]
Start Date: UNK/UNK/1997
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2008
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Coronary artery disease]
Start Date: UNK/UNK/2008
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[cardiac arrest]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Cholelithiasis]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895940
Page 8 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[gastric reflux]
Start Date: UNK/UNK/1975
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Prostate Cancer]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2004
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Bladder Cancer]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Radical prostatectomy]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2004
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Cystoscopy]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895941
Page 9 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[cholecystectomy]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Coronary stent placement]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Coronary stent placement]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[vasectomy]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2004
1.oLine/MH Number: Not Applicable
[ ]Comments
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]Comments
Start Date: Not Applicable
//Comments
Ongoing: Not Applicable Comments
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895942
Page 10 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Coronary Artery Occlusion]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Implantable Cardioverter Defibrillator Insertion]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895943
Page 11 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/14/2020
2.Weight: [192.0]
3.Unit: LB
4.Height: [73.0]
5.Unit: in
6.Body Mass Index: [25.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [96.4]
Unit: F
Temperature Location: EAR
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895944
Page 12 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/14/2020
2.Randomization Number: [228282]
3.Randomization Group: [ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895945
Page 13 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/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 [BM86FM]
5.bSample ID [BM86FN]
5.cSample ID [BM86FP]
5.dSample ID [BPRM4Z]
5.eSample ID [BPRM50]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895946
Page 14 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/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 [BM860H]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895947
Page 15 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/14/2020 08:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895948
Page 16 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895949
Page 17 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895950
Page 18 of 363
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895951
Page 19 of 363
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895952
Page 20 of 363
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: EAR
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895953
Page 21 of 363
***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: 10191037 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/4/2020
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 [BM865H]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895954
Page 22 of 363
***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: 10191037 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/4/2020 06:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895955
Page 23 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895956
Page 24 of 363
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895957
Page 25 of 363
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895958
Page 26 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/5/2020
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 [BP98JX]
5.bSample ID [BRTLJX]
5.cSample ID [BRTLJY]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895959
Page 27 of 363
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L 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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895960
Page 28 of 363
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L 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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8650]
5.bSample ID [BSH3VP]
5.cSample ID [BSH3VR]
5.dSample ID [BSH3VS]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895961
Page 29 of 363
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L 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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895962
Page 30 of 363
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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 [ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895963
Page 31 of 363
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L 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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895964
Page 32 of 363
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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 [ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895965
Page 33 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895966
Page 34 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/26/2020
2.Date of First Symptom Started: Oct/26/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/26/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895967
Page 35 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Col
lectionSpecimen TypeSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/26/202
0 SWABBED MA
TERIAL NASOPHARYNX SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAGN
OSTIC TEST Repeating
Pages
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895968
Page 36 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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: Oct/26/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895969
Page 37 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/26/2020
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 [CV09891]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895970
Page 38 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[Self swab collected.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895971
Page 39 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare Professional: SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare Professional: EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare Professional: PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare Professional: URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare Professional: TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare Professional: OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due to
potential COVID-19 illness?NO
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895972
Page 40 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicable
Not Applicable
Not Applicable
Repeating Pages
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895973
Page 41 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895974
Page 42 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895975
Page 43 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895976
Page 44 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895977
Page 45 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1.Not Applicable Not Applica
ble Not Applicab
le Not Applica
ble Sponsor-Defined Ide
ntifierTest: Result:
Not Applicable Not Applica
ble Not Applica
ble
Not Applicable Not Applica
ble Not Applica
ble
Not Applicable Not Applica
ble Not Applica
ble
Not Applicable Not Applica
ble Not Applica
ble
Not Applicable Not Applica
ble Not Applica
ble
Not Applicable Not Applica
ble Not Applica
ble
Not Applicable Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895978
Page 46 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895979
Page 47 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895980
Page 48 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895981
Page 49 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895982
Page 50 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applicable Not Applica
ble Not Applic
able Sponsor-Defined I
dentifierTest: Result:
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able Repeating
Pages
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895983
Page 51 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895984
Page 52 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895985
Page 53 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895986
Page 54 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895987
Page 55 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895988
Page 56 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895989
Page 57 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895990
Page 58 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895991
Page 59 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895992
Page 60 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895993
Page 61 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895994
Page 62 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895995
Page 63 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Date Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895996
Page 64 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895997
Page 65 of 363
***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: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895998
Page 66 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895999
Page 67 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/18/2020Form: 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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/18/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896000
Page 68 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/18/2020Form: 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: 10191037 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/18/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR85WG]
5.bSample ID [BRZCB6]
5.cSample ID [BRZCB7]
5.dSample ID [BRZCB8]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896001
Page 69 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896002
Page 70 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896003
Page 71 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896004
Page 72 of 363
***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: 10191037 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: [ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896005
Page 73 of 363
***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: 10191037 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:
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896006
Page 74 of 363
***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: 10191037 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 [ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896007
Page 75 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
1.ADVERSE EVEN
T 1 Defibrillator Dischar
ge Oct/15/2020 UNK:U
NK NO
End Date Time:
Oct/15/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EVEN
T 2 Weakness Oct/27/2020 UNK:U
NK NO
End Date Time:
Oct/29/2020 UNK:UNK
Repeating
Pages
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896008
Page 76 of 363
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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)[Defibrillator Discharge]
4.Start Date Time: Oct/15/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/15/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Implanted Defibrillator]
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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896009
Page 77 of 363
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896010
Page 78 of 363
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Weakness]
4.Start Date Time: Oct/27/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/29/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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:
[Medical History of Heart Issues]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896011
Page 79 of 363
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020419183]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896012
Page 80 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Acti
onForm Instance
1. Repeating Pages
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896013
Page 81 of 363
***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: 10191037 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[ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896014
Page 82 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Iden
tifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896015
Page 83 of 363
***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: 10191037 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: //
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896016
Page 84 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionDose Descrip
tionForm Instance
1. Repeating
Pages
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896017
Page 85 of 363
***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: 10191037 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?
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896018
Page 86 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896019
Page 87 of 363
***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: 10191037 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?
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896020
Page 88 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896021
Page 89 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896022
Page 90 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896023
Page 91 of 363
***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: 10191037 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:
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896024
Page 92 of 363
***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: 10191037 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?
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896025
Page 93 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896026
Page 94 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896027
Page 95 of 363
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - 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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896028
Page 96 of 363
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896029
Page 97 of 363
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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 [ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896030
Page 98 of 363
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled 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: 10191037 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 [ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896031
Page 99 of 363
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896032
Page 100 of 363
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896033
Page 101 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/15/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896034
Page 102 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896035
Page 103 of 363
***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: 10191037 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: [ ]
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896036
Page 104 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/5/2020
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896037
Page 105 of 363
***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: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896038
Page 106 of 363
***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: 10191037 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
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896039
Page 107 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-14-2020 11:39:25 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896040
Page 108 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1.oSep-14-2020 09:18:49 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896041
Page 109 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1.oSep-14-2020 09:18:49 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896042
Page 110 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1.oSep-14-2020 09:18:49 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896043
Page 111 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1.oSep-14-2020 09:18:49 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896044
Page 112 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-27-2020 09:14:15 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896045
Page 113 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-27-2020 09:14:15 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896046
Page 114 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-27-2020 09:14:15 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896047
Page 115 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-27-2020 09:14:15 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896048
Page 116 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-27-2020 09:14:15 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896049
Page 117 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: RESPIRATORY TREATMENT - Comments
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5Oct-27-2020 09:14:15 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
6Oct-27-2020 09:14:15 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
FormOct-27-2020 09:14:34 (UTC-06:00) Central Time (US
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090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-27-2020 09:14:34 (UTC-06:00) Central Time (US
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090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-27-2020 09:14:34 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-27-2020 09:14:34 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-27-2020 09:14:34 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896059
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896061
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Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896062
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896063
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896064
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896065
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896066
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896067
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896068
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896069
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896070
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896071
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896072
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896074
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896075
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896076
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896077
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896078
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896079
Page 147 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896080
Page 148 of 363
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896081
Page 149 of 363
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5 fOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5 fOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-27-2020 09:15:09 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896090
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896091
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896092
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896093
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896094
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896095
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896096
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896097
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896098
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896100
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896101
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896102
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896103
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896104
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896105
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896106
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896108
Page 176 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896109
Page 177 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896110
Page 178 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896111
Page 179 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896112
Page 180 of 363
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896113
Page 181 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896118
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896119
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Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896120
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896122
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896123
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896124
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896125
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896126
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896127
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896128
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896129
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Header Text: c4591001
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Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-27-2020 09:15:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
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Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-27-2020 09:15:45 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-27-2020 09:15:45 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
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(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aOct-27-2020 09:15:45 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
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(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aOct-27-2020 09:15:45 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - COVID - Comments
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aOct-27-2020 09:15:45 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - COVID - Comments
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aOct-27-2020 09:15:45 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
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***Confidential***
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Oct/26/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-27-2020 09:15:58 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
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FDA-CBER-2021-5683-0896141
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-27-2020 09:15:58 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0896142
Page 210 of 363
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aOct-27-2020 09:15:58 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0896143
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-27-2020 09:16:10 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0896144
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-27-2020 09:16:10 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896145
Page 213 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-27-2020 09:16:10 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896146
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-27-2020 09:16:10 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896147
Page 215 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-27-2020 09:16:35 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896148
Page 216 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-27-2020 09:16:35 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896149
Page 217 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-27-2020 09:16:35 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896150
Page 218 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-27-2020 09:16:35 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896151
Page 219 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-27-2020 09:16:35 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896152
Page 220 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-27-2020 09:16:35 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896153
Page 221 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Oct-27-2020 09:16:35 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896154
Page 222 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-27-2020 09:17:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896155
Page 223 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-27-2020 09:17:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896156
Page 224 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-27-2020 09:17:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896157
Page 225 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-27-2020 09:17:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896158
Page 226 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-27-2020 09:17:29 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896159
Page 227 of 363
***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: 10191037 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-16-2021 14:53:42 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 18:12:51 (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 Dec-29-2020 15:40:15 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Dec-03-2020 13:54:44 (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-18-2020 15:21:52 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896160
Page 228 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Approved Nov-17-2020 15:37:33 (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-17-2020 07:40:56 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-16-2020 16:08:08 (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-16-2020 15:38:58 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-03-2020 15:05:27 (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.
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896161
Page 229 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
N/A Oct-27-2020 08:59:24 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-21-2020 13:35:05 (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 Oct-16-2020 08:36:56 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-12-2020 12:32:16 (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 Oct-05-2020 13:28:19 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Sep-15-2020 15:55:14 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896162
Page 230 of 363
***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: 10191037 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.
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896163
Page 231 of 363
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-14-2020 11:15:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-14-2020 11:15:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896164
Page 232 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-14-2020 11:15:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/14/2020Initial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896165
Page 233 of 363
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-14-2020 11:15:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10191037Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-14-2020 11:14:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1947Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-14-2020 11:15:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-14-2020 11:15:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) OR O
F SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-14-2020 11:15:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896166
Page 234 of 363
***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: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-14-2020 11:39:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896167
Page 235 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-14-2020 11:39:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-14-2020 11:39:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-14-2020 11:39:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896168
Page 236 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-14-2020 11:39:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term
:Presbyopia
Start Date: UNK/UNK/199
7
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:39:53
(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
Aug-14-2020 11:39:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PresbyopiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-14-2020 11:39:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1997Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-14-2020 11:39:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-14-2020 11:40:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2Initial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896169
Page 237 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History Te
rm:Hypercholesterole
mia
Start Date: UNK/UNK/2008
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:40:10
(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
Aug-14-2020 11:40:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypercholesterolemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-14-2020 11:40:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-14-2020 11:40:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-14-2020 11:40:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:Coronary artery dis
ease
Start Date: UNK/UNK/2008
Ongoing: YESInitial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896170
Page 238 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:40:47
(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
Aug-14-2020 11:40:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Coronary artery diseaseInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-14-2020 11:40:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-14-2020 11:40:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-14-2020 11:41:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:cardiac arrest
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/20
15Initial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896171
Page 239 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:41:04
(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
Aug-20-2020 04:44:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-19-2020 10:55:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Added coronary artery
occlusion to medical
history
Aug-17-2020 12:08:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN: Cardia
arrest is listed. Please
clarify the condition
that led to it (e.g. MI)
and add as a separate
medical history term.
Aug-14-2020 11:41:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cardiac arrestInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-14-2020 11:41:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-14-2020 11:41:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.e
Date Location User Value Reason
Aug-14-2020 11:41:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5Initial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896172
Page 240 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History Ter
m:Cholelithiasis
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/20
17
1.e Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:41:29
(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
Aug-14-2020 11:41:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CholelithiasisInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-14-2020 11:41:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-14-2020 11:41:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.f
Date Location User Value Reason
Aug-14-2020 11:41:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Term
:gastric reflux
Start Date: UNK/UNK/197
5Initial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896173
Page 241 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:41:43
(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
Aug-14-2020 11:41:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
gastric refluxInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-14-2020 11:41:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1975Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-14-2020 11:41:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-14-2020 11:42:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Ter
m:Prostate Cancer
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/20
04Initial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896174
Page 242 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:42:01
(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
Aug-14-2020 11:42:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Prostate CancerInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-14-2020 11:42:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2004Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-14-2020 11:42:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2004Initial Entry
1.h
Date Location User Value Reason
Aug-14-2020 11:42:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Ter
m:Bladder Cancer
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/20
19Initial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896175
Page 243 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:42:17
(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
Aug-20-2020 04:45:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-19-2020 11:01:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered No systemic cytotoxic
therapy required.
Aug-17-2020 12:06:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN: Bladder
cancer diagnosed in
2019 is listed. Please
clarify if it required
any systemic cytotoxic
therapy and if yes,
please confirm
exclusion criterion #13
is not met.
Aug-14-2020 11:42:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Bladder CancerInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-14-2020 11:42:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-14-2020 11:42:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.i
Date Location User Value Reason
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896176
Page 244 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-14-2020 11:42:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Te
rm:Radical prostatecto
my
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/200
4Initial Entry
1.i Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:42:38
(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
Aug-14-2020 11:42:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Radical prostatectomyInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-14-2020 11:42:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2004Initial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896177
Page 245 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.i Ongoing:
Date Location User Value Reason
Aug-14-2020 11:42:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2004Initial Entry
1.j
Date Location User Value Reason
Aug-14-2020 13:50:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 10
Medical History Te
rm:Cystoscopy
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/20
19Transcription Error
Aug-14-2020 11:43:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Te
rm:Cytoscopy
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/20
19Initial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896178
Page 246 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:43:39
(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
Aug-14-2020
14:32:03
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Aug-14-2020
13:50:45
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Aug-14-2020
13:50:45
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
CystoscopyTranscription Error
Aug-14-2020
13:04:50
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Opened Clarify
CYTOSCOPY as
follows...Should the
spelling be
CYSTOSCOPY? If
so, edit to such.
Otherwise, clarify.
Thank you.
Aug-14-2020
11:43:39
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
CytoscopyInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-14-2020 11:43:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.j Ongoing:
Date Location User Value Reason
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0896179
Page 247 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-14-2020 11:43:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.k
Date Location User Value Reason
Aug-14-2020 11:44:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 11
Medical History Ter
m:cholecystectomy
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/20
17Initial Entry
1.k Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:44:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 11:44:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cholecystectomyInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-14-2020 11:44:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-14-2020 11:44:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896180
Page 248 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.l
Date Location User Value Reason
Aug-14-2020 11:44:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:12
Medical History T
erm:Coronary stent place
ment
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008Initial Entry
1.l Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:44:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 11:44:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Coronary stent placementInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-14-2020 11:44:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-14-2020 11:44:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
1.m
Date Location User Value Reason
Aug-14-2020 11:45:10 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896181
Page 249 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central Time
(US & Canada)(autocalc) Line/MH Number
:13
Medical History T
erm:Coronary stent place
ment
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.m Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:45:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 11:45:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Coronary stent placementInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-14-2020 11:45:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-14-2020 11:45:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.n
Date Location User Value Reason
Aug-17-2020 12:24:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 14
Medical History Te
rm:vasectomy
Start Date: UNK/UNK/2004Transcription Error
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896182
Page 250 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/20
04
Aug-14-2020 11:45:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 14
Medical History Te
rm:vasectomy
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/20
04Initial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896183
Page 251 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.n Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:45:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 02:34:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-17-2020 12:24:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Aug-17-2020 12:24:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
vasectomyTranscription Error
Aug-17-2020 11:48:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM QUERY: A
trailing space is
identified. To avoid
processing errors,
please remove the
identified character by
deleting the entry and
re-entering the data
(without using copy
and paste).
Aug-14-2020 11:45:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
vasectomyInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-14-2020 11:45:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2004Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-14-2020 11:45:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2004Initial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0896184
Page 252 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.o
Date Location User Value Reason
Sep-14-2020 09:18:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: Not Applicabl
e
Medical History Term
:Not Applicabl
e
Start Date: Not Applicabl
e
Ongoing: Not Applicabl
eInitial Entry
Sep-14-2020 09:18:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number:
Medical History Term:
Start Date:
Ongoing:Transcription Error
(DELETED)
Sep-11-2020 13:38:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number:
Medical History Term:
Start Date:
Ongoing:Transcription Error
Aug-14-2020 11:46:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:15
Medical History
Term:superficial bladder c
ancer
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019Initial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896185
Page 253 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.o Line/MH Number:
Date Location User Value Reason
Sep-14-2020 09:18:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Sep-14-2020 09:18:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
(DELETED)
Sep-11-2020 13:38:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Aug-14-2020 11:46:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
06:57:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Sep-14-2020
09:19:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answer
edN/A
Sep-14-2020
09:18:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Sep-14-2020
09:18:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry: Transcription
Error
(DELETED)
Sep-12-2020
06:34:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1: Opened Null Term:
Verbatim term
must not be
null/blank.
Sep-11-2020
13:38:36ACV0PFEINFP6000 Data Entry: Transcription
Error
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0896186
Page 254 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896187
Page 255 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 11:46:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
superficial bladder cancerInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-14-2020 09:18:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Sep-14-2020 09:18:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
(DELETED)
Sep-11-2020 13:38:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Aug-14-2020 11:46:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-14-2020 09:18:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Sep-14-2020 09:18:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
(DELETED)
Sep-11-2020 13:38:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Aug-14-2020 11:46:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.p
Date Location User Value Reason
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896188
Page 256 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-19-2020 10:54:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:16
Medical History
Term:Coronary Artery Occ
lusion
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015Initial Entry
1.p Line/MH Number:
Date Location User Value Reason
Aug-19-2020 10:54:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 10:54:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Coronary Artery OcclusionInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-19-2020 10:54:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-19-2020 10:54:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.q
Date Location User Value Reason
Feb-26-2021 08:08:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:17Transcription Error
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896189
Page 257 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical His
tory Term:Implantable Cardioverter
Defibrillator Insertion
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
Feb-16-2021 14:53:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:17
Medical Hist
ory Term:Implantable Cardioverter
Defibrillator Insertion
Start Date: UNK/UNK/2015
Ongoing: YESTranscription Error
Nov-16-2020 15:38:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:17
Medical Histo
ry Term:Implantable Cardiovert
er Defibrillator
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
090177e196ae3e2a\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896190
Page 258 of 363
***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, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.q Line/MH Number:
Date Location User Value Reason
N
…[truncated]