125742 S1 M5 CRF c4591001 1152 11521095

Document text

Page 1 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941532
Page 2 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/19/2020
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941533
Page 3 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11521095]
2.Birth Date: /1953
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:
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941534
Page 4 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941535
Page 5 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941536
Page 6 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941537
Page 7 of 582
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteoarthritis]
Start Date: UNK/UNK/1971
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2008
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type II diabetes]
Start Date: UNK/UNK/1995
Ongoing: NO
End Date:
UNK/UNK/2007
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941538
Page 8 of 582
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anemia]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2017
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[nervous breakdoen]
Start Date: UNK/UNK/1972
Ongoing: NO
End Date:
UNK/UNK/1972
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety]
Start Date: UNK/UNK/1972
Ongoing: YES
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941539
Page 9 of 582
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bipolar depression]
Start Date: UNK/UNK/1972
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[insomnia]
Start Date: UNK/UNK/2010
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[dyspepsia]
Start Date: UNK/UNK/1989
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[irritable bowel]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941540
Page 10 of 582
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seborrheic dermatitis]
Start Date: UNK/UNK/1995
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[arthroscopic surgery right knee]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypothyroid]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941541
Page 11 of 582
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[colitis]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2017
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergy to codeine]
Start Date: UNK/UNK/1983
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergy to thorazine]
Start Date: UNK/UNK/1983
Ongoing: YES
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941542
Page 12 of 582
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gastric bypass]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[arthroscopic surgery left knee]
Start Date: UNK/UNK/1970
Ongoing: NO
End Date:
UNK/UNK/1970
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[arthroscopic surgery left knee]
Start Date: UNK/UNK/1985
Ongoing: NO
End Date:
UNK/UNK/1985
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941543
Page 13 of 582
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[arthroscopic surgery left knee]
Start Date: UNK/UNK/1991
Ongoing: NO
End Date:
UNK/UNK/1991
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cervical disc disease]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cervical disc surgery]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941544
Page 14 of 582
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[thoracic spine disc disease]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[surgery T-3 disc]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.yLine/MH Number: [25]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hyoid bone removed]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941545
Page 15 of 582
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
2.Weight: [181.4]
3.Unit: LB
4.Height: [68.5]
5.Unit: in
6.Body Mass Index: [27.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941546
Page 16 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/19/2020
2.Randomization Number: [233726]
3.Randomization Group: [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941547
Page 17 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
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 [BPYKDJ]
5.bSample ID [BPYKDK]
5.cSample ID [BPYKDL]
5.dSample ID [BNWK33]
5.eSample ID [BNWK34]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941548
Page 18 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
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 [BPYKY8]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941549
Page 19 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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/19/2020 12:42
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941550
Page 20 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941551
Page 21 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941552
Page 22 of 582
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941553
Page 23 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BP9ZF1]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941554
Page 24 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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/10/2020 10:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941555
Page 25 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941556
Page 26 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
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 [BP0SWL]
5.bSample ID [BP0SWM]
5.cSample ID [BNT3F3]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941557
Page 27 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941558
Page 28 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/6/2020
2.Date of First Symptom
Started:Nov/3/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/6/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941559
Page 29 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941560
Page 30 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Loc
ationAssay Code and Descri
ptionDevice TypeForm Insta
nce
 1.Oct/29/
2020 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RESP
SYNDROME CORONA
VIRUS 2 SARS-COV-2
DIAGNOSTIC
TEST Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941561
Page 31 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/29/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection
Location:NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME
CORONAVIRUS 2Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [Negative COVID-19 test required for hospital
admission.]Comments
9.Trade Name Other, Specify: [NALT Unknown] Comments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941562
Page 32 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Subject in hospital and doesn't have his illness kit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941563
Page 33 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Subject is in the hospital]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941564
Page 34 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941565
Page 35 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941566
Page 36 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Treatment Id
entifierCon Non-Drug Treatmen
ts Pre-specifiedTreatmen
tTreatmen
tStart Dat
eForm Instanc
e
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941567
Page 37 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment
Identifier?Not Applicable
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941568
Page 38 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941569
Page 39 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category of Clinical
Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity Gr
adeForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941570
Page 40 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical
Event:Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941571
Page 41 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category f
or Lab Tes
tVendor
NameCollecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.Not Applic
able Not Ap
plicable Not App
licable Not Ap
plicable Sponsor-Defi
ned Identifie
rTest:Result:
Not Applicab
le Not Ap
plicable
 Not Ap
plicable
 
Not Applicab
le Not Ap
plicable
 Not Ap
plicable
 
Not Applicab
le Not Ap
plicable
 Not Ap
plicable
 
Not Applicab
le Not Ap
plicable
 Not Ap
plicable
 
Not Applicab
le Not Ap
plicable
 Not Ap
plicable
 
Not Applicab
le Not Ap
plicable
 Not Ap
plicable
 
Not Applicab
le Not Ap
plicable
 Not Ap
plicable
 Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941572
Page 42 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and
AddressNot Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941573
Page 43 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941574
Page 44 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941575
Page 45 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941576
Page 46 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941577
Page 47 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941578
Page 48 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941579
Page 49 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category
for Lab T
estVendor Na
me (DERIV
ED)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.Not Appli
cable Not Applica
ble Not Ap
plicable
 Not Ap
plicable
 Sponsor-De
fined Identi
fierTest:Result:
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e 
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e 
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e 
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e 
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e 
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e 
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e 
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941580
Page 50 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category
for Lab T
estVendor Na
me (DERIV
ED)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
Sponsor-De
fined Identi
fierTest:Result:
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e 
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e 
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941581
Page 51 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and
AddressNot Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941582
Page 52 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941583
Page 53 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941584
Page 54 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941585
Page 55 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941586
Page 56 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941587
Page 57 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941588
Page 58 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941589
Page 59 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941590
Page 60 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941591
Page 61 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941592
Page 62 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941593
Page 63 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941594
Page 64 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941595
Page 65 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date Time of Assess
mentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled O
xygen)Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941596
Page 66 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941597
Page 67 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart Da
teForm Instan
ce
 1.Not Applicable
 Not Applicabl
e Not Applicable  Not Applica
ble Not App
licable Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941598
Page 68 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic
drug name (including salt
form, where applicable).
Where generic name is
unknown, enter the full trade
or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941599
Page 69 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of Assessm
entLocation of Assessm
entImaging Meth
odOverall Assessm
entForm Instance
 1.Not Applicable  Not Applicable  Not Applicable
 Not Applicable  Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941600
Page 70 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941601
Page 71 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/10/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941602
Page 72 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/10/2021
2.Date of First Symptom
Started:Jan/9/2021
3.Symptoms Ongoing? YES Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941603
Page 73 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941604
Page 74 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of Coll
ectionSpecimen
TypeSpecimen Collectio
n LocationAssay Code and D
escriptionDevice
TypeForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Don
e Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941605
Page 75 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941606
Page 76 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[SUBJECT CAME TO OFFICE FOR SWAB.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941607
Page 77 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/11/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Swab collected in the office on the day after original contact, per
patient preference.]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRRL4M]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941608
Page 78 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941609
Page 79 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941610
Page 80 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Treatment Ide
ntifierCon Non-Drug Treatments P
re-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941611
Page 81 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941612
Page 82 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941613
Page 83 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category of Clinical
Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity Gr
adeForm Instanc
e
 1.        Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941614
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941615
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category for
Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Define
d IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941616
Page 86 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941617
Page 87 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category fo
r Lab TestVendor Name
(DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941618
Page 88 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941619
Page 89 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941620
Page 90 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941621
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941622
Page 92 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941623
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date Time of Assess
mentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled O
xygen)Form Instance
 1.      Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941624
Page 94 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941625
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicat
ions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941626
Page 96 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
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(b) (4)
FDA-CBER-2021-5683-0941627
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of Assessm
entLocation of Assessm
entImaging Meth
odOverall Assessm
entForm Instance
 1.        Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941628
Page 98 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941629
Page 99 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/04/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941630
Page 100 of 582
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/04/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/4/2021
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 [BRCMRF]
5.bSample ID [BRCMRG]
5.cSample ID [BS6KRV]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941631
Page 101 of 582
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941632
Page 102 of 582
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941633
Page 103 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/8/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941634
Page 104 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941635
Page 105 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941636
Page 106 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941637
Page 107 of 582
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# CategoryAE Id
entifie
rAdverse Eve
ntStart DateIs the Adverse Ev
ent Still OngoingForm Insta
nce
 1. ADVERS
E EVEN
T 1 urinary freque
ncy Oct/6/2020
UNK:UNK
 NO
End Date Time:
Nov/1/2020 U
NK:UNK
 Repeating
Pages
 2. ADVERS
E EVEN
T 2 worsening of
bipolar disord
er Oct/29/202
0 UNK:UN
K NO
End Date Time:
Nov/6/2020 U
NK:UNK
 Repeating
Pages
 3. DELETED ADVERS
E EVEN
T 3 cough  Nov/3/2020
UNK:UNK
 NO
End Date Time:
Nov/6/2020 U
NK:UNK
 Repeating
Pages
 4. ADVERS
E EVEN
T 4 Chills  Feb/27/202
1 UNK:UN
K NO
End Date Time:
Feb/27/2021 U
NK:UNK
 Repeating
Pages
 5. ADVERS
E EVEN
T 5 Myalgia  Feb/27/202
1 UNK:UN
K NO
End Date Time:
Feb/27/2021 U
NK:UNK
 Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941638
Page 108 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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)[urinary frequency]
4.Start Date Time: Oct/6/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/1/2020 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
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941639
Page 109 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941640
Page 110 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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)[worsening of bipolar disorder]
4.Start Date Time: Oct/29/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/6/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941641
Page 111 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[historical condition with variability]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941642
Page 112 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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[2020437860]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941643
Page 113 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** 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)[cough]
4.Start Date Time: Nov/3/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/6/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941644
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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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941645
Page 115 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941646
Page 116 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Chills]
4.Start Date Time: Feb/27/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/27/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941647
Page 117 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941648
Page 118 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14.Did the adverse event cause
the subject to be
discontinued from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941649
Page 119 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Myalgia]
4.Start Date Time: Feb/27/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/27/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941650
Page 120 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941651
Page 121 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14.Did the adverse event cause
the subject to be
discontinued from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941652
Page 122 of 582
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication E
rrors ActionForm Instan
ce
 1.         Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941653
Page 123 of 582
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941654
Page 124 of 582
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicat
ions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941655
Page 125 of 582
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt
form, where applicable).
Where generic name is
unknown, enter the full trade
or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941656
Page 126 of 582
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941657
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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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941658
Page 128 of 582
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Catego
ryTreatment Ide
ntifierCon Non-Drug Treatments P
re-specifiedTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941659
Page 129 of 582
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941660
Page 130 of 582
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941661
Page 131 of 582
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941662
Page 132 of 582
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941663
Page 133 of 582
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941664
Page 134 of 582
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941665
Page 135 of 582
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941666
Page 136 of 582
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941667
Page 137 of 582
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941668
Page 138 of 582
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response -
Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941669
Page 139 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/29/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941670
Page 140 of 582
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent Date
://
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941671
Page 141 of 582
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941672
Page 142 of 582
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941673
Page 143 of 582
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/4/2021
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941674
Page 144 of 582
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941675
Page 145 of 582
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/4/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941676
Page 146 of 582
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[COLLECTED AT COVID B1 SAME DAY]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941677
Page 147 of 582
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/4/2021
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 [BRRLC2]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941678
Page 148 of 582
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/4/2021 11:02
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941679
Page 149 of 582
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941680
Page 150 of 582
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMT4L]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941681
Page 151 of 582
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/26/2021 11:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941682
Page 152 of 582
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941683
Page 153 of 582
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941684
Page 154 of 582
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941685
Page 155 of 582
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941686
Page 156 of 582
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941687
Page 157 of 582
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941688
Page 158 of 582
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941689
Page 159 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/8/2020
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941690
Page 160 of 582
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941691
Page 161 of 582
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Donald
Brandon Approved Mar-10-2021 23:14:45 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DonaldBrandon, 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.
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941692
Page 162 of 582
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormAug-19-2020 14:40:13 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941693
Page 163 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormNov-19-2020 14:51:20 (UTC-08:00)
Pacific Time (US & Canada)Subject was hospitalized.
FormNov-19-2020 14:50:39 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
FormNov-13-2020 14:30:35 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
Not Done
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941694
Page 164 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Nov-19-2020 14:50:39 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
1Nov-13-2020 14:30:35 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
Not Done
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941695
Page 165 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Nov-19-2020 14:50:39 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
2Nov-13-2020 14:30:35 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
Not Done
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941696
Page 166 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Nov-19-2020 14:50:39 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
3Nov-13-2020 14:30:35 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
Not Done
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941697
Page 167 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Nov-19-2020 14:50:39 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
4Nov-13-2020 14:30:35 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
Not Done
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941698
Page 168 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Nov-19-2020 14:50:39 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
5Nov-13-2020 14:30:35 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
Not Done
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941699
Page 169 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6Nov-19-2020 14:50:39 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
6Nov-13-2020 14:30:35 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
Not Done
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941700
Page 170 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
7Nov-19-2020 14:50:39 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
7Nov-13-2020 14:30:35 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
Not Done
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941701
Page 171 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
8Nov-19-2020 14:50:39 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
8Nov-13-2020 14:30:35 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
Not Done
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941702
Page 172 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
9Nov-19-2020 14:50:39 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
9Nov-13-2020 14:30:35 (UTC-08:00)
Pacific Time (US & Canada)Subject is in the hospital
Not Done
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941703
Page 173 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormNov-19-2020 15:02:43 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941704
Page 174 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Nov-19-2020 15:02:43 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941705
Page 175 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Nov-19-2020 15:02:43 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941706
Page 176 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
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ItemDate User Comment
3Nov-19-2020 15:02:43 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
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(4), 
(b) (6)
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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ItemDate User Comment
4Nov-19-2020 15:02:43 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
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(4), 
(b) (6)
(b) (4)
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Nov-19-2020 15:02:43 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6Nov-19-2020 15:02:43 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormNov-19-2020 15:04:08 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Nov-19-2020 15:04:08 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Nov-19-2020 15:04:08 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Nov-19-2020 15:04:08 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941714
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Nov-19-2020 15:04:08 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941715
Page 185 of 582
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CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941716
Page 186 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Nov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941717
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Nov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941718
Page 188 of 582
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Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Nov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941719
Page 189 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Nov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941720
Page 190 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.aNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941721
Page 191 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.aNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941722
Page 192 of 582
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.aNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941723
Page 193 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.aNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941724
Page 194 of 582
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.bNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941725
Page 195 of 582
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.bNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941726
Page 196 of 582
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.bNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941727
Page 197 of 582
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.bNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941728
Page 198 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.cNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941729
Page 199 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.cNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941730
Page 200 of 582
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.cNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941731
Page 201 of 582
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.cNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941732
Page 202 of 582
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.dNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941733
Page 203 of 582
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.dNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941734
Page 204 of 582
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.dNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941735
Page 205 of 582
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.dNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941736
Page 206 of 582
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.eNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941737
Page 207 of 582
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.eNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941738
Page 208 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.eNov-19-2020 15:05:14 (UTC-08:00)
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ItemDate User Comment
5.eNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
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(4), 
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ItemDate User Comment
5.fNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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Site No: 1152 Site Name: (1152) California Research Foundation
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ItemDate User Comment
5.fNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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ItemDate User Comment
5.fNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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Site No: 1152 Site Name: (1152) California Research Foundation
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ItemDate User Comment
5.fNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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ItemDate User Comment
5.gNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941745
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
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Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.gNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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(b) (4)
FDA-CBER-2021-5683-0941746
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
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Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.gNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.gNov-19-2020 15:05:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941748
Page 218 of 582
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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ItemDate User Comment
FormNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941749
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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ItemDate User Comment
1Nov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
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(4), 
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
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Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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ItemDate User Comment
2Nov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
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(4), 
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Site No: 1152 Site Name: (1152) California Research Foundation
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Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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ItemDate User Comment
3Nov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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ItemDate User Comment
4Nov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.aNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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ItemDate User Comment
5.aNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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Site No: 1152 Site Name: (1152) California Research Foundation
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Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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ItemDate User Comment
5.aNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
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(4), 
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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ItemDate User Comment
5.aNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.bNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.bNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.bNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.bNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941761
Page 231 of 582
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.cNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941762
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.cNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941763
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.cNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941764
Page 234 of 582
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Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.cNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941765
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.dNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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(b) (4)
FDA-CBER-2021-5683-0941766
Page 236 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.dNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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(b) (4)
FDA-CBER-2021-5683-0941767
Page 237 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.dNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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(b) (4)
FDA-CBER-2021-5683-0941768
Page 238 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.dNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941769
Page 239 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.eNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941770
Page 240 of 582
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.eNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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ItemDate User Comment
5.eNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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ItemDate User Comment
5.eNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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(b) (4)
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
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ItemDate User Comment
5.fNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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Page 244 of 582
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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ItemDate User Comment
5.fNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
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Page 245 of 582
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.fNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941776
Page 246 of 582
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Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.fNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941777
Page 247 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.gNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941778
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Visit: POT_COVID_ILL 1 -
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.gNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941779
Page 249 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.gNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941780
Page 250 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.gNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941781
Page 251 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.hNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941782
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.hNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.hNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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(b) (4)
FDA-CBER-2021-5683-0941784
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.hNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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(b) (4)
FDA-CBER-2021-5683-0941785
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.iNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941786
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.iNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941787
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.iNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.iNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941789
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.jNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941790
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.jNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941791
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.jNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941792
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.jNov-19-2020 15:03:51 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941793
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormNov-19-2020 15:04:23 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941794
Page 264 of 582
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Nov-19-2020 15:04:23 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941795
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2.aNov-19-2020 15:04:23 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941796
Page 266 of 582
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2.aNov-19-2020 15:04:23 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941797
Page 267 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2.aNov-19-2020 15:04:23 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941798
Page 268 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2.aNov-19-2020 15:04:23 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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FDA-CBER-2021-5683-0941799
Page 269 of 582
***Confidential***
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Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormNov-19-2020 15:04:40 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941800
Page 270 of 582
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Nov-19-2020 15:04:40 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941801
Page 271 of 582
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Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2.aNov-19-2020 15:04:40 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941802
Page 272 of 582
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Unscheduled Visit on Nov/06/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormNov-19-2020 15:04:58 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941803
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Site No: 1152 Site Name: (1152) California Research Foundation
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ItemDate User Comment
1Nov-19-2020 15:04:58 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941804
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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ItemDate User Comment
2Nov-19-2020 15:04:58 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941805
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Nov-19-2020 15:04:58 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
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FDA-CBER-2021-5683-0941806
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormNov-19-2020 15:03:35 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941807
Page 277 of 582
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Nov-19-2020 15:03:35 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941808
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: CONCOMITANT MEDICATIONS -
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Nov-19-2020 15:03:35 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941809
Page 279 of 582
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Nov-19-2020 15:03:35 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941810
Page 280 of 582
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Nov-19-2020 15:03:35 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941811
Page 281 of 582
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Nov-19-2020 15:03:35 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941812
Page 282 of 582
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: CONCOMITANT MEDICATIONS -
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6Nov-19-2020 15:03:35 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941813
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormNov-19-2020 15:03:21 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941814
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Nov-19-2020 15:03:21 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941815
Page 285 of 582
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Visit: POT_COVID_ILL 1 -
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Nov-19-2020 15:03:21 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941816
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Header Text: c4591001
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Nov-19-2020 15:03:21 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941817
Page 287 of 582
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Visit: POT_COVID_ILL 1 -
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Nov-19-2020 15:03:21 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) 
(4), 
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(b) (4)
FDA-CBER-2021-5683-0941818
Page 288 of 582
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Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL
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Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Mar-08-2021 16:10:30 (UTC-08:00)
Pacific Time (US & Canada)Cough and sore throat are ongoing as
of 3/8/2021.
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(b) (4)
FDA-CBER-2021-5683-0941819
Page 289 of 582
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Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormJan-11-2021 20:50:54 (UTC-08:00)
Pacific Time (US & Canada)SUBJECT DECLINED
Not Done
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(b) (4)
FDA-CBER-2021-5683-0941820
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Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Jan-11-2021 20:50:54 (UTC-08:00)
Pacific Time (US & Canada)SUBJECT DECLINED
Not Done
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FDA-CBER-2021-5683-0941821
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Jan-11-2021 20:50:54 (UTC-08:00)
Pacific Time (US & Canada)SUBJECT DECLINED
Not Done
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FDA-CBER-2021-5683-0941822
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Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Jan-11-2021 20:50:54 (UTC-08:00)
Pacific Time (US & Canada)SUBJECT DECLINED
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FDA-CBER-2021-5683-0941823
Page 293 of 582
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Unscheduled Visit on Jan/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Jan-11-2021 20:50:54 (UTC-08:00)
Pacific Time (US & Canada)SUBJECT DECLINED
Not Done
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FDA-CBER-2021-5683-0941824
Page 294 of 582
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Unscheduled Visit on Jan/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Jan-11-2021 20:50:54 (UTC-08:00)
Pacific Time (US & Canada)SUBJECT DECLINED
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FDA-CBER-2021-5683-0941825
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Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6Jan-11-2021 20:50:54 (UTC-08:00)
Pacific Time (US & Canada)SUBJECT DECLINED
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FDA-CBER-2021-5683-0941826
Page 296 of 582
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Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
7Jan-11-2021 20:50:54 (UTC-08:00)
Pacific Time (US & Canada)SUBJECT DECLINED
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FDA-CBER-2021-5683-0941827
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Unscheduled Visit on Jan/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
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Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
8Jan-11-2021 20:50:54 (UTC-08:00)
Pacific Time (US & Canada)SUBJECT DECLINED
Not Done
090177e196ae2fc9\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0941828
Page 298 of 582
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
9Jan-11-2021 20:50:54 (UTC-08:00)
Pacific Time (US & Canada)SUBJECT DECLINED
Not Done
090177e196ae2fc9\Final\Final On: 01
…[truncated]