125742 S1 M5 CRF c4591001 1254 12541014

Document text

Page 1 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834615
Page 2 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/28/2020
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834616
Page 3 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12541014]
2.Birth Date: 1951
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834617
Page 4 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834618
Page 5 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834619
Page 6 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834620
Page 7 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CONSTIPATION]
Start Date: UNK/UNK/2012
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RENAL CALCULI]
Start Date: UNK/UNK/2014
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[URINARY BLADDER CALCULI]
Start Date: UNK/UNK/2014
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[URINARY TRACT INFECTIONS]
Start Date: UNK/UNK/2014
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DEPRESSION CHRONIC]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834621
Page 8 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MYOPIA]
Start Date: UNK/UNK/1970
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PRESBYOPIA]
Start Date: UNK/UNK/2010
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LEFT URETER STENT Insertion]
Start Date: Feb/UNK/2020
Ongoing: NO
End Date:
Feb/UNK/2020
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RIGHT URETER STENT Insertion]
Start Date: Mar/UNK/2020
Ongoing: NO
End Date:
Mar/UNK/2020
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[overactive bladder]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834622
Page 9 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[benign prostatic hyperplasia]
Start Date: UNK/UNK/2015
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ear infections, intermittent]
Start Date: UNK/UNK/2000
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tinnitus, intermittent]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834623
Page 10 of 323
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [77.0]
3.Unit: kg
4.Height: [195.0]
5.Unit: cm
6.Body Mass Index: [20.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.3]
Unit: C
Temperature Location: EAR
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834624
Page 11 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [244810]
3.Randomization Group: [ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834625
Page 12 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BP8JMD]
5.bSample ID [BP8JMF]
5.cSample ID [BP8JMG]
5.dSample ID [BLG7XW]
5.eSample ID [BLG7XX]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834626
Page 13 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BP8JMC]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834627
Page 14 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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/28/2020 10:55
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
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834628
Page 15 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834629
Page 16 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834630
Page 17 of 323
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.3]
Unit: C
Temperature Location: EAR
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834631
Page 18 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8K3P]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834632
Page 19 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/18/2020 12:23
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
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834633
Page 20 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834634
Page 21 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9XNX]
5.bSample ID [BLG8BD]
5.cSample ID [BLG8BF]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834635
Page 22 of 323
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834636
Page 23 of 323
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834637
Page 24 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834638
Page 25 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834639
Page 26 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834640
Page 27 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834641
Page 28 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834642
Page 29 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/21/2021
2.Date of First Symptom Started: Jan/19/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/1/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834643
Page 30 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Symptoms - Other
5.aSymptoms - Other Text: [Nausea]
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(b) (4)
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Page 31 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of C
ollectionSpecimen Typ
eSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/21/202
1 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
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(b) (4)
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Page 32 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/21/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
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(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jan/27/2021
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 [CV20450]
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(b) (4)
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Page 34 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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:[Telehealth Visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
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(b) (4)
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Page 35 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834649
Page 36 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Jan/21/2021  NO
Discharge Date:
Jan/23/2021
 Repeating Pages
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(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Jan/21/2021
4.Ongoing? NO
Discharge Date:
Jan/23/2021
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(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
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(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
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(b) (4)
FDA-CBER-2021-5683-0834653
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Pancolitis]
Date of Diagnosis:
Jan/21/2021
3.Toxicity Grade: 4
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(b) (4)
FDA-CBER-2021-5683-0834654
Page 41 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
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(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
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Page 43 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for
Lab TestVendor NameCollecti
on Date:Specime
n TypeLab ResultForm Instan
ce
 1.CLINICAL C
HEMISTRY Sherman Oaks Hospital
4929 Van Nuys Blvd, Sh
erman Oaks, CA 91403 Jan/21/2
021 BLOOD
 Sponsor-Defi
ned Identifie
rTest:Res
ult:
329  C Reactive Protei
n_PX329 [ ] 
30  Alanine Aminotr
ansferase_PX30 18 
28  Aspartate Aminot
ransferase_PX28 16 
35  Alkaline Phospha
tase_PX35 59 
21  Bilirubin_PX21  1.2 
47  Blood Urea Nitro
gen_PX47 18 
48  Creatinine_PX48  1.5 Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0834657
Page 44 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Sherman Oaks Hospital
4929 Van Nuys Blvd, Sherman Oaks, CA 91403]
3.Collection Date: Jan/21/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [18]
Not Done:
LNMT Low
[12]
High
[78]
Unit
U/L
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(b) (4)
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Page 45 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [16]
Not Done:
LNMT Low
[15]
High
[37]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [59]
Not Done:
LNMT Low
[46]
High
[116]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [1.2]
Not Done:
LNMT Low
[0.2]
High
[1.0]
Unit
mg/dL
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834659
Page 46 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [18]
Not Done:
LNMT Low
[7]
High
[18]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.5]
Not Done:
LNMT Low
[0.6]
High
[1.3]
Unit
mg/dL
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
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Page 47 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for
Lab TestVendor Name (DERIVE
D)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.HEMATOL
OGY Sherman Oaks Hospital
4929 Van Nuys Blvd, Sher
man Oaks, CA 91403 Jan/21/20
21 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
1  Hemoglobin
_PX1 15.3
 
2  Hematocrit_
PX2 48 
3  Erythrocytes
_PX3 5.35
 
5  Platelets_P
X5 150 
7  Leukocytes_
PX7 16.9
 
608  Neutrophils
_PX608 15.3
 
609  Eosinophils
_PX609 0.0 
612  Monocytes_
PX612 1.2 
610  Basophils_P
X610 0.0 
611  Lymphocyte
s_PX611 0.4 Repeating
Pages
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834661
Page 48 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for
Lab TestVendor Name (DERIVE
D)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 2.HEMATOLO
GY Glendale Memorial Hospi
tal and Health Center
1420 South Central Ave
Glendale CA 91204 Jan/22/20
21 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
1  Hemoglobin
_PX1 13.3
 
2  Hematocrit_
PX2 40.8
 
3  Erythrocytes
_PX3 4.65
 
5  Platelets_P
X5 138 
7  Leukocytes_
PX7 11.4 
608  Neutrophils
_PX608 9.3 
609  Eosinophils
_PX609 0.1 
612  Monocytes_
PX612 0.0 
610  Basophils_P
X610 0.1 
611  Lymphocyte
s_PX611 1.2 Repeating
Pages
 3.HEMATOLO
GY Glendale Memorial Hospi
tal and Health Center
1420 South Central Ave
Glendale CA 91204 Jan/23/20
21 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
1  Hemoglobin
_PX1 12.7
 
2  Hematocrit_
PX2 38.9
 
3  Erythrocytes
_PX3 4.41
 
5  Platelets_P
X5 138 
7  Leukocytes_
PX7 7.3 
608  Neutrophils 6.2 Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0834662
Page 49 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for
Lab TestVendor Name (DERIVE
D)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
Sponsor-Defin
ed IdentifierTest:Res
ult:
_PX608 
609  Eosinophils
_PX609 0.1 
612  Monocytes_
PX612 0.7 
610  Basophils_P
X610 0.0 
611  Lymphocyte
s_PX611 1.4 
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
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Page 50 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Sherman Oaks Hospital
4929 Van Nuys Blvd, Sherman Oaks, CA 91403]
3.Collection Date: Jan/21/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [15.3]
Not Done:
LNMT Low
[13.5]
High
[17.5]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [48]
Not Done:
LNMT Low
[39]
High
[51]
Unit
%
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834664
Page 51 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [5.35]
Not Done:
LNMT Low
[4.5]
High
[6.0]
Unit
/uL
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [150]
Not Done:
LNMT Low
[150]
High
[450]
Unit
10^6/cu mm
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [16.9]
Not Done:
LNMT Low
[4.3]
High
[11.0]
Unit
/uL
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834665
Page 52 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [15.3]
Not Done:
LNMT Low
[1.8]
High
[8.9]
Unit
10^6/cu mm
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.7]
Unit
10^6/cu mm
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [1.2]
Not Done:
LNMT Low
[0.1]
High
[1.30]
Unit
10^6/cu mm
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
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Page 53 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^6/cu mm
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.4]
Not Done:
LNMT Low
[0.8]
High
[4.8]
Unit
10^6/cu mm
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834667
Page 54 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Glendale Memorial Hospital and Health Center
1420 South Central Ave
Glendale CA 91204]
3.Collection Date: Jan/22/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.3]
Not Done:
LNMT Low
[14.0]
High
[17.0]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [40.8]
Not Done:
LNMT Low
[39.0]
High
[55.0]
Unit
%
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834668
Page 55 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.65]
Not Done:
LNMT Low
[3.5]
High
[5.5]
Unit
/uL
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [138]
Not Done:
LNMT Low
[130]
High
[400]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [11.4]
Not Done:
LNMT Low
[4.5]
High
[11.0]
Unit
10^3/uL
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834669
Page 56 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [9.3]
Not Done:
LNMT Low
[1.8]
High
[8.9]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.1]
Not Done:
LNMT Low
[0.0]
High
[0.7]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.0]
Not Done:
LNMT Low
[0.1]
High
[1.30]
Unit
10^3/uL
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834670
Page 57 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.1]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.2]
Not Done:
LNMT Low
[0.8]
High
[4.8]
Unit
10^3/uL
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834671
Page 58 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Glendale Memorial Hospital and Health Center
1420 South Central Ave
Glendale CA 91204]
3.Collection Date: Jan/23/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.7]
Not Done:
LNMT Low
[14.0]
High
[17.0]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [38.9]
Not Done:
LNMT Low
[39.0]
High
[55.0]
Unit
%
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834672
Page 59 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.41]
Not Done:
LNMT Low
[3.5]
High
[5.50]
Unit
/uL
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [138]
Not Done:
LNMT Low
[130]
High
[400]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [7.3]
Not Done:
LNMT Low
[4.5]
High
[11.0]
Unit
10^3/uL
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834673
Page 60 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [6.2]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.1]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.7]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
10^3/uL
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834674
Page 61 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.0]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.4]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
10^3/uL
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834675
Page 62 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
 1.Jan/21/2021 Record Identifier: Systolic: Diastolic:
1  124  80 Repeating Pages
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834676
Page 63 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/21/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [124]
Diastolic: [80]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [93]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834677
Page 64 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
 1.Jan/21/2021 Record Identifier: Oxygen Saturation
1  94.0 Repeating Pages
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834678
Page 65 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
 2.Jan/23/2021 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834679
Page 66 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/21/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [94.0]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834680
Page 67 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/23/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834681
Page 68 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834682
Page 69 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834683
Page 70 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834684
Page 71 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834685
Page 72 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of As
sessmentLocation of A
ssessmentImaging
MethodOverall AssessmentForm Instan
ce
 1.Jan/21/202
1 OTHER
If other, spec
ify:
Abdomen a
nd Pelvis
 CT SCA
N ABNORMAL
If abnormal, specify findings:
Nonspecific colitis possibly pancolitis. Multiple sub centimete
r non obstructing right renal stones. Multiple bladder stones.
 Repeating
Pages
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834686
Page 73 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/21/2021
2.Location of Assessment: OTHER
If other, specify:
[Abdomen and Pelvis]
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Nonspecific colitis possibly pancolitis. Multiple sub centimeter non obstructing
right renal stones. Multiple bladder stones.]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834687
Page 74 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/19/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834688
Page 75 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/19/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/19/2021
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 [BPFV6S]
5.bSample ID [BPFV6T]
5.cSample ID [BRCM95]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834689
Page 76 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834690
Page 77 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834691
Page 78 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834692
Page 79 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834693
Page 80 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834694
Page 81 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834695
Page 82 of 323
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  SORENESS AT INJE
CTION SITE Sep/18/2020 17
:00 NO
End Date Time:
Sep/19/2020 UNK:U
NK
 Repeating
Pages
 2. ADVERSE
EVENT 2  Clostridium Difficile
Colitis Jan/21/2021 U
NK:UNK NO
End Date Time:
Feb/1/2021 UNK:U
NK
 Repeating
Pages
 3. DELETED ADVERSE
EVENT 3  ear infection  Jan/14/2021 U
NK:UNK YES  Repeating
Pages
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834696
Page 83 of 323
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[SORENESS AT INJECTION SITE]
4.Start Date Time: Sep/18/2020 17:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/19/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834697
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834698
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***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[Clostridium Difficile Colitis]
4.Start Date Time: Jan/21/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/1/2021 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
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
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834699
Page 86 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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:
[colitis due to Amoxicillin for ear infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021064841]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834700
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***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ear infection ]
4.Start Date Time: Jan/14/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[possibly underlying eustacean tube dysfucntion ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834701
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834702
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category Medication ErrorStart
DateIs the medication
error Still Ongoin
gStudy Medicat
ion Errors Act
ionForm Insta
nce
 1.MEDICAT
ION ERR
OR SUBJECT DOSED WITH IP THAT HAD TE
MPERATURE EXCURSION (PRODUCT ST
ORAGE ERROR) Aug/2
8/202
0 NO
End Date:
Aug/28/2020
 NO ACTION T
AKEN Repeating
Pages
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834703
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Medication Error
1.Category: MEDICATION ERROR
2.Medication Error (Type of
Medication Error):[SUBJECT DOSED WITH IP THAT HAD TEMPERATURE EXCURSION
(PRODUCT STORAGE ERROR)]
3.Start Date: Aug/28/2020
4.Is the medication error still ongoing? NO
End Date:
Aug/28/2020
5.Latest Action Taken with Study
Treatment:NO ACTION TAKEN
6.Was a Concomitant Medication
given?NO
7.Was a Non-Drug Treatment given? NO
8.Did the Medication Error cause the
subject to be discontinued from the
study?NO
9.Was this medication error associated
with any adverse events?NO
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834704
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
 1. DELETED 1  VACCINATION
S NO  Hydromorpho
ne HCI Jan/21/2
021 Repeating
Pages
 2. DELETED 2  VACCINATION
S NO  Lactated Ring
ers Jan/21/2
021 Repeating
Pages
 3. DELETED 3  VACCINATION
S NO  Ondansetron
HCI Jan/21/2
021 Repeating
Pages
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834705
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Hydromorphone HCI ]
5.Date: Jan/21/2021
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834706
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***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Lactated Ringers ]
5.Date: Jan/21/2021
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834707
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***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [3]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Ondansetron HCI ]
5.Date: Jan/21/2021
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834708
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834709
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834710
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834711
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834712
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834713
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834714
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***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834715
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***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834716
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***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834717
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***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834718
Page 105 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834719
Page 106 of 323
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834720
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***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834721
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***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834722
Page 109 of 323
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834723
Page 110 of 323
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834724
Page 111 of 323
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834725
Page 112 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/3/2020
2.Primary Reason for Unblinding: OTHER
If other, specify:
[IP temperature excursion]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834726
Page 113 of 323
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834727
Page 114 of 323
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834728
Page 115 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/16/2020
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834729
Page 116 of 323
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834730
Page 117 of 323
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert Heller  Approved Mar-09-2021 13:48:05 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertHeller, 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.
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834731
Page 118 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-01-2020 13:40:28 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834732
Page 119 of 323
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert Heller  Approved Mar-09-2021 13:48:05 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertHeller, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-26-2021 18:05:40 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Heller  Approved Jan-21-2021 19:58:14 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertHeller, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-11-2020 21:09:08 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Heller  Approved Oct-21-2020 22:59:21 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834733
Page 120 of 323
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
By my dated signature below, I, RobertHeller, 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.
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834734
Page 121 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-01-2020 13:37:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-01-2020 13:37:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834735
Page 122 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-01-2020 13:38:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/28/2020Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834736
Page 123 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-01-2020 13:37:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12541014Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-01-2020 13:37:30
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1951Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-01-2020 13:39:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-01-2020 13:39:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-01-2020 13:39:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834737
Page 124 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-01-2020 13:40:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834738
Page 125 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-01-2020 13:41:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-01-2020 13:41:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-01-2020 13:41:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834739
Page 126 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Sep-01-2020 13:41:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:CONSTIPATI
ON
Start Date: UNK/UNK/20
12
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-01-2020 13:41:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 13:41:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CONSTIPATIONInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-01-2020 13:41:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-01-2020 13:41:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834740
Page 127 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-01-2020 13:44:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:RENAL CALC
ULI
Start Date: UNK/UNK/20
14
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-01-2020 13:44:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 13:44:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RENAL CALCULIInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-01-2020 13:44:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-01-2020 13:44:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-01-2020 13:45:30
(UTC-08:00) Pacific TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu 3Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834741
Page 128 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US & Canada) mber:
Medical Histo
ry Term:URINARY BLADD
ER CALCULI
Start Date: UNK/UNK/2014
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-01-2020 13:45:30
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 13:45:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
URINARY BLADDER CALCULIInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-01-2020 13:45:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-01-2020 13:45:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-02-2020 15:52:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:URINARY TRAC
T INFECTIONS
Start Date: UNK/UNK/2014New Information
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834742
Page 129 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Ongoing: YES
Sep-01-2020 16:59:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:URINARY TRAC
T INFECTIONS
Start Date: Aug/UNK/2020
Ongoing: YESInitial Entry
Sep-01-2020 13:45:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:URINARY TRAC
T INFECTIONS
Start Date: Aug/UNK/2020
Ongoing:Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834743
Page 130 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d Line/MH Number:
Date Location User Value Reason
Sep-01-2020 13:45:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 04:09:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Sep-08-2020 17:59:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered NO ACTIVE
URINARY TRACT
INFECTION SINCE
APRIL 2020 (5
MONTHS).
Sep-07-2020 05:21:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened GPD Clin: Per IC3
and Criteria for
Temporary Delay of
Enrolment (Protocol
5.5), please confirm
stability of
symptoms within 6
weeks of enrolment
and no acute event
within 48h before
study intervention
administration
Sep-01-2020 13:45:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
URINARY TRACT INFECTION
SInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-02-2020 23:36:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-02-2020 15:52:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834744
Page 131 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-02-2020 15:52:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014New Information
Sep-02-2020 01:06:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Kindly review
and confirm if the
start date
(UNK/Aug/2020) is
before first
vaccination date
28/Aug/2020.
Sep-01-2020 16:58:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Sep-01-2020 13:55:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
28/Aug/2020. Please
review and update
as appropriate.
Sep-01-2020 13:45:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/UNK/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-01-2020 16:59:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-02-2020 15:52:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:5
Medical Histo
ry Term:DEPRESSION
CHRONIC
Start Date: UNK/UNK/2018
Ongoing: YESTranscription Error
Sep-01-2020 13:47:01
(UTC-08:00) PacificACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num 5Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0834745
Page 132 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada) ber:
Medical Histo
ry Term:DEPRESSION
CHRONIC
Start Date: UNK/UNK/2020
Ongoing: YES
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834746
Page 133 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e Line/MH Number:
Date Location User Value Reason
Sep-01-2020 13:47:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 13:47:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DEPRESSION CHRONICInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-02-2020 23:36:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-02-2020 15:52:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Sep-02-2020 15:52:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Transcription Error
Sep-02-2020 01:06:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Kindly review
and confirm if the
start date
(UNK/UNK/2020)
is before first
vaccination date
28/Aug/2020.
Sep-01-2020 16:59:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Sep-01-2020 13:55:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
28/Aug/2020. Please
review and update as
appropriate.
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834747
Page 134 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-01-2020 13:47:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-01-2020 13:47:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-01-2020 13:47:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Te
rm:MYOPIA
Start Date: UNK/UNK/19
70
Ongoing: YESInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834748
Page 135 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.f Line/MH Number:
Date Location User Value Reason
Sep-01-2020 13:47:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 13:47:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MYOPIAInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-01-2020 13:47:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1970Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-01-2020 13:47:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-01-2020 13:48:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Te
rm:PRESBYOPI
A
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834749
Page 136 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.g Line/MH Number:
Date Location User Value Reason
Sep-01-2020 13:48:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 13:48:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRESBYOPIAInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-01-2020 13:48:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-01-2020 13:48:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-02-2020 15:52:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:LEFT URETER ST
ENT Insertion
Start Date: Feb/UNK/2020
Ongoing: NO
End Date:
Feb/UNK/2020New Information
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834750
Page 137 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-01-2020 13:50:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:LEFT URETER
STENT
Start Date: Feb/UNK/2020
Ongoing: NO
End Date:
Feb/UNK/202
0Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834751
Page 138 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.h Line/MH Number:
Date Location User Value Reason
Sep-01-2020 13:50:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020
02:00:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Close
dDiscrepancy has
been closed.
Sep-02-2020
15:52:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answ
eredNew Information
Sep-02-2020
15:52:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFT URETE
R STENT Inse
rtionNew Information
Sep-01-2020
22:10:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Open
edClarify LEFT
URETER STENT
as follows...Device
only term. Are you
reporting
INSERTION?
REMOVAL?
INFECTION OF?
COMPLICATION
WITH? If so,
update the verbatim
term as such.
Otherwise clarify
and edit the term.
Thank you.
Sep-01-2020
13:50:00
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  Data Entry:
LEFT URETE
R STENTInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834752
Page 139 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
& Canada)
1.h Start Date:
Date Location User Value Reason
Sep-01-2020 13:50:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/UNK/2020Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-01-2020 13:50:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Feb/UNK/2020Initial Entry
1.i
Date Location User Value Reason
Sep-02-2020 15:53:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH N
umber:9
Medical His
tory Term:RIGHT URETER S
TENT Insertion
Start Date: Mar/UNK/2020
Ongoing: NO
End Date:
Mar/UNK/2020New Information
Sep-01-2020 13:51:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9
Medical Histo
ry Term:RIGHT URETER
STENT
Start Date: Mar/UNK/2020
Ongoing: NO
End Date:
Mar/UNK/202
0Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834753
Page 140 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.i Line/MH Number:
Date Location User Value Reason
Sep-01-2020 13:51:15
(UTC-08:00) Pacific 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
Feb-01-2021 07:27:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Jan-27-2021 10:30:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Late entry medhx
has been entered
Jan-27-2021 07:09:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Clinical_ Per report
the subject has
"benign prostatic
hyperplasia and
overactive bladder",
however this
additional
information is
missing on CRF.
Please revise and
update form
accordingly. Thanks.
Sep-02-2020 15:53:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHT URETER STENT Insertio
nNew Information
Sep-01-2020 13:51:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHT URETER STENTInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-01-2020 13:51:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/UNK/2020Initial Entry
1.i Ongoing:
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834754
Page 141 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-01-2020 13:51:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Mar/UNK/2020Initial Entry
1.j
Date Location User Value Reason
Jan-27-2021 09:59:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History T
erm:overactive blad
der
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834755
Page 142 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.j Line/MH Number:
Date Location User Value Reason
Jan-27-2021 09:59:43
(UTC-08:00) Pacific 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
Jan-27-2021 09:59:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
overactive bladderInitial Entry
1.j Start Date:
Date Location User Value Reason
Jan-27-2021 09:59:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.j Ongoing:
Date Location User Value Reason
Jan-27-2021 09:59:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Jan-27-2021 10:01:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:11
Medical Histor
y Term:benign prostatic h
yperplasia
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834756
Page 143 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.k Line/MH Number:
Date Location User Value Reason
Jan-27-2021 10:01:42
(UTC-08:00) Pacific 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
Jan-27-2021 10:01:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
benign prostatic hyperplasiaInitial Entry
1.k Start Date:
Date Location User Value Reason
Jan-27-2021 10:01:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.k Ongoing:
Date Location User Value Reason
Jan-27-2021 10:01:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Feb-03-2021 15:44:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12
Medical Histor
y Term:ear infections, int
ermittent
Start Date: UNK/UNK/2000
Ongoing: YESInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834757
Page 144 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.l Line/MH Number:
Date Location User Value Reason
Feb-03-2021 15:44:55
(UTC-08:00) Pacific 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
Feb-03-2021 15:44:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ear infections, intermittentInitial Entry
1.l Start Date:
Date Location User Value Reason
Feb-03-2021 15:44:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.l Ongoing:
Date Location User Value Reason
Feb-03-2021 15:44:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Feb-03-2021 15:45:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:13
Medical History T
erm:tinnitus, intermi
ttent
Start Date: UNK/UNK/200
0
Ongoing: YESInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834758
Page 145 of 323
***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: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.m Line/MH Number:
Date Location User Value Reason
Feb-03-2021 15:45:15
(UTC-08:00) Pacific 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
Feb-03-2021 15:45:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
tinnitus, intermittentInitial Entry
1.m Start Date:
Date Location User Value Reason
Feb-03-2021 15:45:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.m Ongoing:
Date Location User Value Reason
Feb-03-2021 15:45:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834759
Page 146 of 323
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020 13:52:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-01-2020 13:52:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
77.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-01-2020 13:52:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-01-2020 13:52:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
195.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-01-2020 13:52:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-01-2020 13:52:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
20.2Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834760
Page 147 of 323
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.a
Date Location User Value Reason
Sep-01-2020 13:52:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 37.3
Temperature Unit: C
Temperature Location:: EARInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-01-2020 13:52:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-01-2020 13:52:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
37.3Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-01-2020 13:52:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-01-2020 13:52:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834761
Page 148 of 323
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-01-2020 13:53:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-01-2020 13:53:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
244810Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834762
Page 149 of 323
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 18:00:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 18:00:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 18:00:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-01-2020 18:00:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-01-2020 18:00:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 18:00:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8JMDInitial Entry
5.a Sample ID
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834763
Page 150 of 323
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-01-2020 18:00:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8JMDInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020 18:00:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8JMFInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020 18:00:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8JMFInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020 18:01:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8JMGInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020 18:01:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8JMGInitial Entry
5.d
Date Location User Value Reason
Sep-14-2020 14:35:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLG7XWInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0834764
Page 151 of 323
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.d Sample ID
Date Location User Value Reason
Sep-14-2020 14:35:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLG7XWInitial Entry
5.e
Date Location User Value Reason
Sep-14-2020 14:36:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLG7XXInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-14-2020 14:36:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLG7XXInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834765
Page 152 of 323
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 13:54:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 13:54:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 16:01:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-02-2020 01:02:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-01-2020 13:54:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-01-2020 13:54:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834766
Page 153 of 323
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-02-2020 16:01:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8JMCInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 16:01:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP8JMCInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834767
Page 154 of 323
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-01-2020 13:55:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020 13:55:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020 13:55:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-01-2020 13:55:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020 10:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020 13:55:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-01-2020 13:55:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834768
Page 155 of 323
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Route:
Date Location User Value Reason
Sep-01-2020 13:55:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-01-2020 13:55:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-01-2020 13:55:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834769
Page 156 of 323
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-07-2020 02:22:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-03-2020 10:27:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-03-2020 10:27:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTTranscription Error
Sep-03-2020 05:19:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened eDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
'Yes' however VAX 1
eDiary records are not
available for the
subject. Please verify
and update. Else,
confirm in query
response appropriately.
Sep-01-2020 13:55:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-
DIARY COLLECTED FOR TH
IS SUBJECTInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834770
Page 157 of 323
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020 14:55:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834771
Page 158 of 323
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 14:56:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 14:56:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 37.3
Temperature Unit: C
Temperature Location:: EARInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 14:56:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 14:56:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
37.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020 14:56:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834772
Page 159 of 323
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-18-2020 14:56:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834773
Page 160 of 323
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-19-2020 13:47:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-19-2020 13:47:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-19-2020 13:48:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-19-2020 13:47:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-19-2020 13:47:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-19-2020 13:48:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8K3PInitial Entry
5.a Sample ID
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834774
Page 161 of 323
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-19-2020 13:48:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8K3PInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834775
Page 162 of 323
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 14:57:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 14:57:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 14:57:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 14:57:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020 12:23Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 14:57:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020 14:57:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834776
Page 163 of 323
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Route:
Date Location User Value Reason
Sep-18-2020 14:57:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020 14:57:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-18-2020 14:57:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834777
Page 164 of 323
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-21-2020 15:41:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-20-2020 17:43:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered updated
Oct-19-2020 21:49:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Patient
completed the
treatment phase and
reached at Visit 3.
Kindly consider to
update EOT form
with matching V3
date or else clarify.
Thank you.
Oct-16-2020 16:46:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834778
Page 165 of 323
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 13:31:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 13:31:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 13:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 13:31:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-16-2020 13:31:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-16-2020 13:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR9XNXInitial Entry
5.a Sample ID
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834779
Page 166 of 323
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-16-2020 13:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR9XNXInitial Entry
5.b
Date Location User Value Reason
Oct-16-2020 13:32:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLG8BDInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-16-2020 13:32:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLG8BDInitial Entry
5.c
Date Location User Value Reason
Oct-16-2020 13:32:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLG8BFInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-16-2020 13:32:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLG8BFInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834780
Page 167 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-05-2021 09:45:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 5: Closed Response satisfies
query
Feb-03-2021 16:37:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 5: Answered Medical records have
been received and
follow up SAE forms
have been submitted
Feb-01-2021 08:39:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 5: Opened Clin: It was stated in
the SAE report
#2021064841 that
the subject was
hospitalized. Please
obtain subject
medical records and
update as appropriate
the CRF forms
(COVID TEST, ILL
SEVERE, LAB
CHEM/HME,
VITAL COV,
PULSE OX,
OXYGEN,
VASOPRESS,
IMAGING)
Jan-28-2021 22:36:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed As per the update
Jan-28-2021 22:36:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed As per the update
Jan-27-2021 12:03:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 4: Reissued:Candidate Pending for subject
to complete since he
was hospitalized
Jan-26-2021 18:08:58
(UTC-08:00) PacificACV0PFEINFP6000  Query 4: Answered Pending for subject
to complete since he
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834781
Page 168 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada) was hospitalized
Jan-25-2021 03:28:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened DM: Date of Visit is
completed but Self
Swab CRF is not
initiated. Please
review and update
the data as
appropriate. Thanks
Jan-22-2021 11:44:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed opened candidate
query - 1/22/2021
site is waiting for
swap from subject
Jan-22-2021 11:44:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Candidate 1/22/2021 - Data will
be updated once
received from
subject
Jan-22-2021 09:10:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Data will be updated
once received from
subject
Jan-22-2021 09:10:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Data will be updated
once received from
subject
Jan-22-2021 04:21:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened DM: Kindly review
and complete
‘Microbiology
Specimen, Illness
Details form' at this
visit. Thank you.
Jan-21-2021 22:15:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Date of Visit is
completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update as
appropriate.
Jan-21-2021 16:15:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-21-2021 16:09:04 ACV0PFEINFP6000  auto query Query 2: Candidate Date of Visit is
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (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)
FDA-CBER-2021-5683-0834782
Page 169 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)(autoquery) completed but Date
of Assessment in the
Signs and Symptoms
form is missing.
Please review and
update as
appropriate.
Jan-21-2021 16:09:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update as
appropriate.
Jan-21-2021 16:09:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/21/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-21-2021 16:09:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0834783
Page 170 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/21/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-03-2021 16:37:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolved:
Feb/1/2021New Information
Jan-21-2021 16:15:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0834784
Page 171 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.a Was symptom present?
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834785
Page 172 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.c Symptoms:
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAINInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0834786
Page 173 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Symptom
Present:NO
4.e Symptoms:
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCLE
PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834787
Page 174 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREASE
D SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE TH
ROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHEA
Symptom Present: YESInitial Entry
4.h Symptoms:
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.i
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0834788
Page 175 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Jan-29-2021 16:30:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: NONew Information
Jan-21-2021 16:15:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: YESInitial Entry
4.i Symptoms:
Date Location User Value Reason
Jan-21-2021 16:15:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-29-2021 16:30:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NONew Information
Jan-21-2021 16:15:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
5.a
Date Location User Value Reason
Jan-29-2021 16:30:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other: NauseaInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Jan-29-2021 16:30:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NauseaInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (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)
FDA-CBER-2021-5683-0834789
Page 176 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Jan-27-2021 09:44:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834790
Page 177 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Jan-27-2021 09:44:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/21/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-27-2021 09:44:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-27-2021 09:44:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Jan-27-2021 09:44:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Jan-27-2021 09:44:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Jan-27-2021 09:44:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834791
Page 178 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Test Result:
Date Location User Value Reason
Jan-27-2021 09:44:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Jan-27-2021 09:44:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NALT UnknownInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834792
Page 179 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021 15:31:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021 15:31:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021 15:31:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-27-2021 15:31:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jan-27-2021 15:31:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/27/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021 15:31:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: CV20450Initial Entry
5.a Sample ID
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834793
Page 180 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Jan-27-2021 15:31:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CV20450Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834794
Page 181 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-21-2021 16:15:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-21-2021 16:15:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-21-2021 16:15:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-21-2021 16:15:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Telehealth VisitInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834795
Page 182 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:EMERGENCY
ROOM
Occurrence of
Visits or Contac
ts:YES
Number of Visi
ts or Contacts:
1Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834796
Page 183 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.c
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of V
isits or Contacts
:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834797
Page 184 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Contac
ts:NOInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834798
Page 185 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or C
ontacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-21-2021 16:17:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Feb-05-2021 09:45:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834799
Page 186 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-03-2021 11:10:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Feb-03-2021 11:10:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Has the subject been in intensive
care due to potential COVID-19
illness?
NONew Information
Feb-01-2021 08:41:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: It was stated in
the SAE report
#2021064841 that
the subject was
hospitalized. Please
review and update as
appropriate this form
Jan-21-2021 16:17:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834800
Page 187 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-03-2021 11:12:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834801
Page 188 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Feb-03-2021 11:12:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Feb-03-2021 11:12:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HOSPITALInitial Entry
3. Admission Date:
Date Location User Value Reason
Feb-03-2021 11:12:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/21/2021Initial Entry
4. Ongoing?
Date Location User Value Reason
Feb-03-2021 11:12:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Discharge Date:
Jan/23/2021Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834802
Page 189 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Jan-27-2021 09:45:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Feb-05-2021 09:45:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 2: Closed Response satisfies
query
Feb-03-2021 11:13:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered New Information
Feb-03-2021 11:13:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Diagnosis:
Pancolitis
Date of Diagnosis:
Jan/21/2021New Information
Feb-01-2021 08:45:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 2: Opened Clin: It was stated in
the SAE report
#2021064841 that
the subject
experienced
PANCOLITIS.
Please consider in
response to "Was a
diagnosis obtained
for Potential
COVID-19 Illness"
entering
PANCOLITIS
Feb-01-2021 08:45:09
(UTC-08:00) PacificACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834803
Page 190 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
Feb-01-2021 08:44:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: It was stated in
the SAE report
#2021064841 that
the subject
experienced
COLITIS. Please
consider in response
to "Was a diagnosis
obtained for Potential
COVID-19 Illness"
entering COLITIS
Jan-27-2021 09:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Jan-27-2021 09:45:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834804
Page 191 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Audit Trail
Form Version: 21-Aug-2020 02:49 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834805
Page 192 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
CLINICAL CHEMISTRYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sherman Oaks Hospital
4929 Van Nuys Blvd, Sherman Oa
ks, CA 91403Initial Entry
3. Collection Date:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/21/2021Initial Entry
4. Specimen Type:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:329
Test:: C Reactive Prote
in_PX329
Result::
Not Done:: NOT DONE
Lab Normal Ran
ge:Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834806
Page 193 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sponsor ID:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
329Initial Entry
5.a Test:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
C Reactive Protein_PX329Initial Entry
5.a Not Done:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.b
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:30
Test:: Alanine Aminotra
nsferase_PX30
Result:: 18
Not Done::
Lab Normal R
ange:Low
12
High
78
Unit
U/LInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834807
Page 194 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b Sponsor ID:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30Initial Entry
5.b Test:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Alanine Aminotransferase_PX30Initial Entry
5.b Result:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
18Initial Entry
5.b LNMT
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Low
12
High
78
Unit
U/LInitial Entry
5.c
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:28
Test:: Aspartate Aminotr
ansferase_PX28
Result:: 16Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834808
Page 195 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Not Done::
Lab Normal R
ange:Low
15
High
37
Unit
U/L
5.c Sponsor ID:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28Initial Entry
5.c Test:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aspartate Aminotransferase_PX28Initial Entry
5.c Result:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
16Initial Entry
5.c LNMT
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Low
15
High
37
Unit
U/LInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834809
Page 196 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.d
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:35
Test:: Alkaline Phospha
tase_PX35
Result:: 59
Not Done::
Lab Normal Ra
nge:Low
46
High
116
Unit
U/LInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834810
Page 197 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.d Sponsor ID:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
35Initial Entry
5.d Test:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Alkaline Phosphatase_PX35Initial Entry
5.d Result:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
59Initial Entry
5.d LNMT
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Low
46
High
116
Unit
U/LInitial Entry
5.e
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Ide
ntifier:21
Test:: Bilirubin_P
X21
Result:: 1.2Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834811
Page 198 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Not Done::
Lab Normal Range: Low
0.2
High
1.0
Unit
mg/dL
5.e Sponsor ID:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21Initial Entry
5.e Test:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Bilirubin_PX21Initial Entry
5.e Result:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1.2Initial Entry
5.e LNMT
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Low
0.2
High
1.0
Unit
mg/dLInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834812
Page 199 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.f
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:47
Test:: Blood Urea Nitro
gen_PX47
Result:: 18
Not Done::
Lab Normal Ra
nge:Low
7
High
18
Unit
mg/dLInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834813
Page 200 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.f Sponsor ID:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
47Initial Entry
5.f Test:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Blood Urea Nitrogen_PX47Initial Entry
5.f Result:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
18Initial Entry
5.f LNMT
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Low
7
High
18
Unit
mg/dLInitial Entry
5.g
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Ide
ntifier:48
Test:: Creatinine_P
X48
Result:: 1.5Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834814
Page 201 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Not Done::
Lab Normal Range: Low
0.6
High
1.3
Unit
mg/dL
5.g Sponsor ID:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
48Initial Entry
5.g Test:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Creatinine_PX48Initial Entry
5.g Result:
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1.5Initial Entry
5.g LNMT
Date Location User Value Reason
Jan-27-2021 09:07:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Low
0.6
High
1.3
Unit
mg/dLInitial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834815
Page 202 of 323
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Audit Trail
Form Version: 21-Aug-2020 02:51 Form Status:
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Jan-27-2021 09:23:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834816
Page 203 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-27-2021 09:23:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HEMATOLOGYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Jan-27-2021 09:23:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sherman Oaks Hospital
4929 Van Nuys Blvd, Sherman Oa
ks, CA 91403Initial Entry
3. Collection Date:
Date Location User Value Reason
Jan-27-2021 09:23:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/21/2021Initial Entry
4. Specimen Type:
Date Location User Value Reason
Jan-27-2021 09:23:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Jan-27-2021 09:23:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:1
Test:: Hemoglobin_
PX1
Result:: 15.3
Not Done::Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834817
Page 204 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Lab Normal Range: Low
13.5
High
17.5
Unit
g/dL
5.a Sponsor ID:
Date Location User Value Reason
Jan-27-2021 09:23:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
5.a Test:
Date Location User Value Reason
Jan-27-2021 09:23:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Hemoglobin_PX1Initial Entry
5.a Result:
Date Location User Value Reason
Jan-27-2021 09:23:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
15.3Initial Entry
5.a LNMT
Date Location User Value Reason
Jan-27-2021 09:23:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Low
13.5
High
17.5
Unit
g/dLInitial Entry
5.b
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834818
Page 205 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Jan-27-2021 09:23:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Ide
ntifier:2
Test:: Hematocrit_
PX2
Result:: 48
Not Done::
Lab Normal Range: Low
39
High
51
Unit
%Initial Entry
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834819
Page 206 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b Sponsor ID:
Date Location User Value Reason
Jan-27-2021 09:23:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
5.b Test:
Date Location User Value Reason
Jan-27-2021 09:23:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Hematocrit_PX2Initial Entry
5.b Result:
Date Location User Value Reason
Jan-27-2021 09:23:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
48Initial Entry
5.b LNMT
Date Location User Value Reason
Jan-27-2021 09:23:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Low
39
High
51
Unit
%Initial Entry
5.c
Date Location User Value Reason
Jan-30-2021 10:17:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined I
dentifier:3
Test:: Erythrocytes
_PX3
Result:: 5.35New Information
090177e196ae3e80\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834820
Page 207 of 323
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1254 Site Name: (1254) Bayview Research Group
Subject No: 12541014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Not Done::
Lab Normal Rang
e:Low
4.5
High
6.0
Unit
/uL
Jan-27-2021 09:23:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:3
Tes
…[truncated]