Document text
Page 1 of 224
***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: 11521316 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
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942457
Page 2 of 224
***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: 11521316 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
Sep/3/2020
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942458
Page 3 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11521316]
2.Birth Date: /1968
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:
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0942459
Page 4 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/3/2020
2.Erroneous Visit
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942460
Page 5 of 224
***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: 11521316 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
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942461
Page 6 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942462
Page 7 of 224
***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: 11521316 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:[nephrolithiasis]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[allergy to guava]
Start Date: UNK/UNK/2016
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[left rotator cuff tears]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942463
Page 8 of 224
***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: 11521316 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:[left rotator cuff repair]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[left rotator cuff tear]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[left rotator cuff repair]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942464
Page 9 of 224
***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: 11521316 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:[left rotator cuff tear]
Start Date: UNK/UNK/1989
Ongoing: NO
End Date:
UNK/UNK/1989
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[left rotator cuff repair]
Start Date: UNK/UNK/1989
Ongoing: NO
End Date:
UNK/UNK/1989
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[vasectomy]
Start Date: UNK/UNK/1987
Ongoing: NO
End Date:
UNK/UNK/1987
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942465
Page 10 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[vasectomy reversal]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942466
Page 11 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
2.Weight: [185.6]
3.Unit: LB
4.Height: [66.0]
5.Unit: in
6.Body Mass Index: [30.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942467
Page 12 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/3/2020
2.Randomization Number: [80140]
3.Randomization Group: [ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942468
Page 13 of 224
***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: 11521316 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:
Sep/3/2020
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 [BP9KY6]
5.bSample ID [BP9KY7]
5.cSample ID [BP9KY8]
5.dSample ID [BNWJS5]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942469
Page 14 of 224
***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: 11521316 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/3/2020
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 [BP9Z89]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942470
Page 15 of 224
***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: 11521316 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/3/2020 12:43
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
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942471
Page 16 of 224
***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: 11521316 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
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942472
Page 17 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942473
Page 18 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942474
Page 19 of 224
***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: 11521316 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/22/2020
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 [BP0SDY]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942475
Page 20 of 224
***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: 11521316 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/22/2020 11:17
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
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942476
Page 21 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942477
Page 22 of 224
***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: 11521316 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/20/2020
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 [BRJGG0]
5.bSample ID [BRJGG1]
5.cSample ID [BS6JVV]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942478
Page 23 of 224
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942479
Page 24 of 224
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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 [ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942480
Page 25 of 224
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942481
Page 26 of 224
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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 [ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942482
Page 27 of 224
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942483
Page 28 of 224
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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 [ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942484
Page 29 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: 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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/8/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942485
Page 30 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/8/2020
2.Date of First Symptom
Started:Dec/7/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/14/2020
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? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942486
Page 31 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
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: [ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942487
Page 32 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942488
Page 33 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942489
Page 34 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: 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: 11521316 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? YES
Date of Collection:
Dec/9/2020
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 [CV20471]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942490
Page 35 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: 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: 11521316 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:[sELF SWAB OBTAINED]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Done
[ ]Comments
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942491
Page 36 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942492
Page 37 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942493
Page 38 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942494
Page 39 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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?
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942495
Page 40 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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: 2
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942496
Page 41 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1. Repeating
Pages
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942497
Page 42 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: 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: 11521316 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:
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942498
Page 43 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1. Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942499
Page 44 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942500
Page 45 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
1. Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942501
Page 46 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942502
Page 47 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942503
Page 48 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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:[ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942504
Page 49 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942505
Page 50 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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 % [ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942506
Page 51 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1. Repeating
Pages
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942507
Page 52 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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):[ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942508
Page 53 of 224
***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: 11521316 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
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942509
Page 54 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: 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: 11521316 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?
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942510
Page 55 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1. Repeating
Pages
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942511
Page 56 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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:
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942512
Page 57 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/05/2021Form: 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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942513
Page 58 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/05/2021Form: 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: 11521316 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:
Jan/5/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[NO RETAIN SAMPLE OBTAINED]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGVX5]
5.bSample ID [BRGVX6]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942514
Page 59 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942515
Page 60 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942516
Page 61 of 224
***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: 11521316 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/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942517
Page 62 of 224
***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: 11521316 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: [ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942518
Page 63 of 224
***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: 11521316 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:
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942519
Page 64 of 224
***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: 11521316 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 [ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942520
Page 65 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Body ach
es Sep/23/2020 U
NK:UNK NO
End Date Time:
Sep/23/2020 UNK:
UNK
Repeating
Pages
2.ADVERSE
EVENT 2 Bell's pal
sy Feb/23/2021 U
NK:UNK YES Repeating
Pages
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942521
Page 66 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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)[Body aches]
4.Start Date Time: Sep/23/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/23/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942522
Page 67 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942523
Page 68 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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[ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942524
Page 69 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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)[Bell's palsy]
4.Start Date Time: Feb/23/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942525
Page 70 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[virus]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942526
Page 71 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942527
Page 72 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942528
Page 73 of 224
***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: 11521316 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[ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942529
Page 74 of 224
***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: 11521316 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
DateForm Instan
ce
1.[ ] [ ] Repeating
Pages
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942530
Page 75 of 224
***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: 11521316 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: //
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942531
Page 76 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942532
Page 77 of 224
***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: 11521316 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?
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942533
Page 78 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942534
Page 79 of 224
***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: 11521316 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?
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942535
Page 80 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942536
Page 81 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942537
Page 82 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942538
Page 83 of 224
***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: 11521316 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:
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942539
Page 84 of 224
***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: 11521316 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?
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942540
Page 85 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942541
Page 86 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942542
Page 87 of 224
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942543
Page 88 of 224
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942544
Page 89 of 224
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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 [ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942545
Page 90 of 224
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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 [ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942546
Page 91 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942547
Page 92 of 224
***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, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942548
Page 93 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/15/2020
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942549
Page 94 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942550
Page 95 of 224
***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: 11521316 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: [ ]
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942551
Page 96 of 224
***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: 11521316 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/20/2020
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942552
Page 97 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942553
Page 98 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942554
Page 99 of 224
***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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormSep-03-2020 13:29:17 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942555
Page 100 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormDec-15-2020 20:27:11 (UTC-08:00)
Pacific Time (US & Canada)Subject didn't have the test done
Not Done
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942556
Page 101 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Dec-15-2020 20:27:11 (UTC-08:00)
Pacific Time (US & Canada)Subject didn't have the test done
Not Done
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942557
Page 102 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Dec-15-2020 20:27:11 (UTC-08:00)
Pacific Time (US & Canada)Subject didn't have the test done
Not Done
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942558
Page 103 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Dec-15-2020 20:27:11 (UTC-08:00)
Pacific Time (US & Canada)Subject didn't have the test done
Not Done
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942559
Page 104 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Dec-15-2020 20:27:11 (UTC-08:00)
Pacific Time (US & Canada)Subject didn't have the test done
Not Done
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942560
Page 105 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Dec-15-2020 20:27:11 (UTC-08:00)
Pacific Time (US & Canada)Subject didn't have the test done
Not Done
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942561
Page 106 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6Dec-15-2020 20:27:11 (UTC-08:00)
Pacific Time (US & Canada)Subject didn't have the test done
Not Done
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942562
Page 107 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
7Dec-15-2020 20:27:11 (UTC-08:00)
Pacific Time (US & Canada)Subject didn't have the test done
Not Done
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942563
Page 108 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
8Dec-15-2020 20:27:11 (UTC-08:00)
Pacific Time (US & Canada)Subject didn't have the test done
Not Done
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942564
Page 109 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
9Dec-15-2020 20:27:11 (UTC-08:00)
Pacific Time (US & Canada)Subject didn't have the test done
Not Done
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942565
Page 110 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.aDec-09-2020 14:55:45 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942566
Page 111 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-22-2021 22:58:08 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Donald
Brandon Approved Jan-21-2021 11:03:06 (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.
N/A Dec-09-2020 14:49:03 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0942567
Page 112 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Affidavit:
N/A
Donald
Brandon Approved Oct-30-2020 12:58:27 (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.
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942568
Page 113 of 224
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-03-2020
13:27:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-03-2020
13:27:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942569
Page 114 of 224
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-03-2020
13:27:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/3/2020Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942570
Page 115 of 224
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-03-2020
13:26:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11521316Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-03-2020
13:26:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1968Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-03-2020
13:28:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942571
Page 116 of 224
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-03-2020
13:28:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-03-2020
13:28:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942572
Page 117 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-03-2020
13:29:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942573
Page 118 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-03-2020
13:29:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-03-2020
13:29:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-03-2020
13:29:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942574
Page 119 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Sep-03-2020
13:30:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:nephrolithi
asis
Start Date
:UNK/UN
K/2015
Ongoing: NO
End Date
:
UNK/U
NK/201
5Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-03-2020
13:30:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942575
Page 120 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-03-2020
13:30:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
nephrolithiasisInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-03-2020
13:30:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-03-2020
13:30:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.b
Date Location User Value Reason
Sep-03-2020
13:30:57
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942576
Page 121 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada) Medical His
tory Term:allergy t
o guava
Start Date: UNK/U
NK/201
6
Ongoing: YES
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942577
Page 122 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Line/MH Number:
Date Location User Value Reason
Sep-03-2020
13:30:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020
13:30:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
allergy to guavaInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-03-2020
13:30:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-03-2020
13:30:57ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0942578
Page 123 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)
1.c
Date Location User Value Reason
Sep-03-2020
13:31:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:left rotator
cuff tears
Start Date
:UNK/UN
K/2015
Ongoing: NO
End Date
:
UNK/U
NK/201
5Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0942579
Page 124 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.c Line/MH Number:
Date Location User Value Reason
Sep-03-2020
13:31:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020
13:31:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
left rotator cuff tearsInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-03-2020
13:31:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-03-2020
13:31:37ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0942580
Page 125 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/2015
1.d
Date Location User Value Reason
Sep-03-2020
13:32:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History T
erm:left rotator
cuff repair
Start Date
:UNK/UNK
/2015
Ongoing: NO
End Date
:
UNK/U
NK/201
5Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0942581
Page 126 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.d Line/MH Number:
Date Location User Value Reason
Sep-03-2020
13:32:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020
13:32:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
left rotator cuff repai
rInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-03-2020
13:32:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-03-2020
13:32:16ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0942582
Page 127 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/2015
1.e
Date Location User Value Reason
Sep-03-2020
13:33:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical H
istory Ter
m:left rotator
cuff tear
Start Date
:UNK/UN
K/2014
Ongoing: NO
End Date
:
UNK/U
NK/201
4Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0942583
Page 128 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.e Line/MH Number:
Date Location User Value Reason
Sep-03-2020
13:33:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020
13:33:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
left rotator cuff tearInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-03-2020
13:33:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-03-2020
13:33:45ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0942584
Page 129 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/2014
1.f
Date Location User Value Reason
Sep-03-2020
13:35:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical
History T
erm:left rotator
cuff repair
Start Date
:UNK/UNK
/2014
Ongoing: NO
End Date
:
UNK/U
NK/201
4Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0942585
Page 130 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.f Line/MH Number:
Date Location User Value Reason
Sep-03-2020
13:35:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020
13:35:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
left rotator cuff repai
rInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-03-2020
13:35:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-03-2020
13:35:06ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0942586
Page 131 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/2014
1.g
Date Location User Value Reason
Sep-03-2020
13:35:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical H
istory Ter
m:left rotator
cuff tear
Start Date
:UNK/UN
K/1989
Ongoing: NO
End Date
:
UNK/U
NK/198
9Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0942587
Page 132 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.g Line/MH Number:
Date Location User Value Reason
Sep-03-2020
13:35:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020
13:35:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
left rotator cuff tearInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-03-2020
13:35:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1989Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-03-2020
13:35:43ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0942588
Page 133 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/1989
1.h
Date Location User Value Reason
Sep-03-2020
13:36:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical
History T
erm:left rotator
cuff repair
Start Date
:UNK/UNK
/1989
Ongoing: NO
End Date
:
UNK/U
NK/198
9Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0942589
Page 134 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.h Line/MH Number:
Date Location User Value Reason
Sep-03-2020
13:36:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020
13:36:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
left rotator cuff repai
rInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-03-2020
13:36:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1989Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-03-2020
13:36:14ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0942590
Page 135 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/1989
1.i
Date Location User Value Reason
Sep-03-2020
13:36:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:9
Medical H
istory Ter
m:vasectomy
Start Date
:UNK/UN
K/1987
Ongoing: NO
End Date
:
UNK/U
NK/198
7Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0942591
Page 136 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.i Line/MH Number:
Date Location User Value Reason
Sep-03-2020
13:36:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020
13:36:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
vasectomyInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-03-2020
13:36:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1987Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-03-2020
13:36:42ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0942592
Page 137 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/1987
1.j
Date Location User Value Reason
Sep-03-2020
13:37:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:10
Medical H
istory Ter
m:vasectomy
reversal
Start Date
:UNK/UN
K/2001
Ongoing: NO
End Date
:
UNK/U
NK/200
1Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0942593
Page 138 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.j Line/MH Number:
Date Location User Value Reason
Sep-03-2020
13:37:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020
13:37:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
vasectomy reversalInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-03-2020
13:37:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-03-2020
13:37:07ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0942594
Page 139 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/2001
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0942595
Page 140 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-03-2020
13:37:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-03-2020
13:37:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
185.6Initial Entry
3. Unit:
Date Location User Value Reason
Sep-03-2020
13:37:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942596
Page 141 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-03-2020
13:37:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
66.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-03-2020
13:37:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-03-2020
13:37:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
7.a
Date Location User Value Reason
Sep-03-2020
13:37:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.4Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942597
Page 142 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-03-2020
13:37:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-03-2020
13:37:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.4Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-03-2020
13:37:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942598
Page 143 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.a Temperature Location:
Date Location User Value Reason
Sep-03-2020
13:37:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942599
Page 144 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-03-2020
13:38:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-03-2020
13:38:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
80140Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942600
Page 145 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020
13:38:39
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020
13:38:39
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020
10:53:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-04-2020
01:30:28
(UTC-08:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942601
Page 146 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-03-2020
13:38:39
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-03-2020
13:38:39
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020
10:53:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9KY
6Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942602
Page 147 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-04-2020
10:53:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9KY6Initial Entry
5.b
Date Location User Value Reason
Sep-04-2020
10:53:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9KY
7Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-04-2020
10:53:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9KY7Initial Entry
5.c
Date Location User Value Reason
Sep-04-2020
10:54:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9KY
8Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942603
Page 148 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c Sample ID
Date Location User Value Reason
Sep-04-2020
10:54:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9KY8Initial Entry
5.d
Date Location User Value Reason
Sep-04-2020
10:54:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BNWJS
5Initial Entry
5.d Sample ID
Date Location User Value Reason
Sep-04-2020
10:54:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BNWJS5Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942604
Page 149 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020
13:38:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020
13:38:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020
10:54:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-04-2020
01:30:28
(UTC-08:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942605
Page 150 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-03-2020
13:38:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-03-2020
13:38:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020
10:54:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9Z89Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942606
Page 151 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-04-2020
10:54:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9Z89Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942607
Page 152 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-03-2020
13:39:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020
13:39:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020
13:39:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942608
Page 153 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-03-2020
13:39:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 12:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020
13:39:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-03-2020
13:39:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-03-2020
13:39:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942609
Page 154 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-03-2020
13:39:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-03-2020
13:39:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942610
Page 155 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-03-2020
14:15:39
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942611
Page 156 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-22-2020
11:54:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942612
Page 157 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020
11:55:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020
11:55:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.9
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020
11:55:07
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942613
Page 158 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-22-2020
11:55:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-22-2020
11:55:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-22-2020
11:55:07
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942614
Page 159 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020
11:55:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020
11:55:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020
14:55:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-22-2020
11:55:17
(UTC-08:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942615
Page 160 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-22-2020
11:55:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-22-2020
14:55:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP0SD
YInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020
14:55:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP0SDYInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942616
Page 161 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-22-2020
11:55:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020
11:55:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020
11:55:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942617
Page 162 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-22-2020
11:55:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020 11:17Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020
11:55:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-22-2020
11:55:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-22-2020
11:55:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942618
Page 163 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-22-2020
11:55:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-22-2020
11:55:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942619
Page 164 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020
12:21:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942620
Page 165 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020
12:22:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020
12:22:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020
18:51:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-20-2020
12:22:01
(UTC-08:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942621
Page 166 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-20-2020
12:22:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020
18:51:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRJGG
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020
18:51:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRJGG0Initial Entry
5.b
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942622
Page 167 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Oct-20-2020
18:51:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRJGG
1Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020
18:51:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRJGG1Initial Entry
5.c
Date Location User Value Reason
Oct-20-2020
18:51:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BS6JV
VInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942623
Page 168 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c Sample ID
Date Location User Value Reason
Oct-20-2020
18:51:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BS6JVVInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942624
Page 169 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-16-2020
22:37:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Query 4: Closed Response
satisfies query
Dec-15-2020
20:27:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Query 4: Answere
dDone
Dec-11-2020
22:34:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Query 4: Opened DM: Kindly
review and
complete
‘Microbiology
Specimen form'
at this visit.
Thank you.
Dec-09-2020
14:56:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Deleted Close Auto
Query
Dec-09-2020
14:54:43
(UTC-08:00)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidat
eDate of Visit is
completed but
Date of
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)(6)
(b)(4),(b)
(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942625
Page 170 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)Collection in
both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and
update as
appropriate.
Dec-09-2020
14:50:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Dec-09-2020
14:49:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidat
eDate of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms form
is missing.
Please review
and update as
appropriate.
Dec-09-2020
14:49:02
(UTC-08:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
eDate of Visit is
completed but
Date of
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942626
Page 171 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)Collection in
both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and
update as
appropriate.
Dec-09-2020
14:49:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/8/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-09-2020
14:49:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942627
Page 172 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/8/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-23-2021
07:48:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed data updated
Feb-22-2021
22:58:08
(UTC-08:00)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New
Information
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942628
Page 173 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)
Feb-22-2021
22:58:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symp
tom Resolved:
Dec/14/2020New
Information
Feb-12-2021
03:19:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened 60 days have
passed since
the Date of
First Symptom
Started and
Ongoing is
YES. Please
confirm if
symptoms are
truly ongoing.
Else, please
enter Date of
Last Symptom
Resolved.
Dec-23-2020
07:08:52
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Dec-21-2020
16:10:08
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000 Query 1: Answered Done
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),
(b)(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942629
Page 174 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
Dec-21-2020
07:38:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:O
penedData field is
unlocked.
Kindly make
the necessary
update
Dec-15-2020
20:25:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Please unlock.
Dec-13-2020
19:31:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Per source
document,
patient
reported new
loss of
taste/smell on
12/10. Kindly
review and
update EDC as
appropriate.
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)
(6)
(b)(4),
(b)(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942630
Page 175 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEV
ER
Symptom Pre
sent:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR I
NCREASE
D COUGHInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942631
Page 176 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sympt
om Pre
sent:YES
4.b Symptoms:
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symp
toms:NEW OR IN
CREASED S
HORTNESS
OF BREATHInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942632
Page 177 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Symp
tom P
resen
t:YES
4.c Symptoms:
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED SHORTNESS OF
BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHIL
LS
Symptom Pr
esent:NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942633
Page 178 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.d Symptoms:
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE PA
IN
Sympt
om Pr
esent:NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942634
Page 179 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.e Symptoms:
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Dec-21-2020
16:09:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pr
esent:YESNew
Information
Dec-09-2020
14:49:57
(UTC-08:00)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW LOSS
OF TASTEInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942635
Page 180 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)OR SMELL
Sympt
om Pr
esent:NO
4.f Symptoms:
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TAS
TE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Dec-21-2020
16:09:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESNew
Information
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942636
Page 181 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THRO
AT
Sympt
om Pr
esent:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Dec-09-2020
14:49:57ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0942637
Page 182 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)HEA
Symptom P
resent:NO
4.h Symptoms:
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMIT
ING
Symptom P
resent:NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942638
Page 183 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.i Symptoms:
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Dec-09-2020
14:49:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942639
Page 184 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Dec-15-2020
20:27:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Dec-15-2020
20:27:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Dec-15-2020
20:27:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942640
Page 185 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-15-2020
20:27:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Dec-15-2020
20:27:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Dec-15-2020
20:27:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Dec-15-2020
20:27:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942641
Page 186 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
8. Comments/Findings/Details:
Date Location User Value Reason
Dec-15-2020
20:27:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Dec-15-2020
20:27:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942642
Page 187 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-09-2020
14:56:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-09-2020
14:56:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-09-2020
14:56:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-09-2020
14:56:03
(UTC-08:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942643
Page 188 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Dec-09-2020
14:56:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/9/2020Initial Entry
5.a
Date Location User Value Reason
Dec-09-2020
14:56:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:CV2047
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-09-2020
14:56:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CV20471Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942644
Page 189 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-09-2020
14:50:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-09-2020
14:50:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-09-2020
14:55:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Closed Close Auto
Query
Dec-09-2020
14:55:00
(UTC-08:00)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto
Query
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942645
Page 190 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)
Dec-09-2020
14:54:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Opened 'Sample
Collected?' is
marked as No
and 'If no
sample was
collected or
sample was not
collected
according to
protocol, please
provide reason'
is missing.
Please review
and update as
appropriate.
Dec-09-2020
14:54:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened Response to
"Sample
Collected?" is
No, but
Barcodes are
present on the
page.
Dec-09-2020
14:54:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription
Error
Dec-09-2020
14:51:44ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942646
Page 191 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)
Dec-09-2020
14:51:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Dec-09-2020
14:51:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/8/2020Transcription
Error
Dec-09-2020
14:50:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
appropriate.
Dec-09-2020
14:50:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of
Collection
09/Dec/2020 is
different from
Date of Visit
08/Dec/2020.
Please review
and update as
appropriate,
else clarify.
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942647
Page 192 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-09-2020
14:50:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/9/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Dec-09-2020
14:55:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
sELF SWAB OBTAI
NEDInitial Entry
5.a
Date Location User Value Reason
Dec-09-2020
14:55:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:Not Don
eInitial Entry
Dec-09-2020
14:55:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID:Transcription
Error
Dec-09-2020
14:51:44
(UTC-08:00)ACV0PFEINFP6000 Data Entry:
Sample I CV2047Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942648
Page 193 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)D: 1
5.a Sample ID
Date Location User Value Reason
Dec-09-2020
14:55:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Dec-09-2020
14:55:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Dec-09-2020
14:55:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry: Transcription
Error
Dec-09-2020
14:51:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not
6 characters in
length. Please
review and
correct as
appropriate.
Dec-09-2020
14:51:44
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000 Data Entry:
CV20471Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942649
Page 194 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942650
Page 195 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Pract
itioner:SPEC
IALI
ST
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942651
Page 196 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Pr
actitioner:EMERG
ENCY
ROOM
Occurrenc
e of Visits o
r Contacts:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942652
Page 197 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of P
ractitione
r:PRIMAR
Y CARE
PHYSICI
AN
Occurren
ce of Visit
s or Cont
acts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE PH
YSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942653
Page 198 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Prac
titioner:URGE
NT C
ARE
Occurrence
of Visits or
Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)ACV0PFEINFP6000 Data Entry:
Type of P
ractitioneTELEPH
ONE COInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942654
Page 199 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)r: NSULTA
TION
Occurren
ce of Visit
s or Cont
acts:NO
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CONS
ULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000 Data Entry:
Type of Practit
ioner:OT
HE
RInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942655
Page 200 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada) Occurrence of
Visits or Conta
cts:NO
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Dec-09-2020
14:57:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942656
Page 201 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/08/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Dec-09-2020
15:15:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-
19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Dec-09-2020
15:15:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Dec-09-2020
15:15:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942657
Page 202 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/05/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-05-2021
11:28:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/5/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-05-2021
11:28:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942658
Page 203 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/05/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-05-2021
11:28:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-05-2021
11:28:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-05-2021
22:12:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-05-2021
11:28:13
(UTC-08:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942659
Page 204 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/05/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-05-2021
11:28:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Jan/5/2021Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Jan-05-2021
22:12:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO RETAIN SAMPL
E OBTAINEDInitial Entry
5.a
Date Location User Value Reason
Jan-05-2021
22:12:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRGVX
5Initial Entry
5.a Sample ID
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942660
Page 205 of 224
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/05/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Jan-05-2021
22:12:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRGVX5Initial Entry
5.b
Date Location User Value Reason
Jan-05-2021
22:12:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRGVX
6Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-05-2021
22:12:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRGVX6Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0942661
Page 206 of 224
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
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: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-20-2020
12:22:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-20-2020
12:22:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-20-2020
12:22:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942662
Page 207 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Mar-12-2021
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942663
Page 208 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Mar-12-2021
15:36:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942664
Page 209 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Mar-12-2021
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-12-2021
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-12-2021
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Body achesInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942665
Page 210 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-12-2021
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-12-2021
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/23/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-12-2021
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
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).
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942666
Page 211 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Mar-12-2021
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Mar-12-2021
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-12-2021
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-12-2021
15:31:49
(UTC-08:00)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942667
Page 212 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-12-2021
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-12-2021
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-12-2021
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942668
Page 213 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Mar-12-2021
15:31:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942669
Page 214 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Mar-12-2021
15:36:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-12-2021
15:36:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-12-2021
15:36:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Bell's palsyInitial Entry
4. Start Date Time:
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942670
Page 215 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Mar-12-2021
15:36:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/23/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-12-2021
15:36:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-12-2021
15:36:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
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
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942671
Page 216 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
prevent above outcomes).
Date Location User Value Reason
Mar-12-2021
15:36:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Mar-12-2021
15:36:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-12-2021
15:36:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), th
is event is due to:
OTHER
If Other, specify:
virusInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942672
Page 217 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-12-2021
15:36:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-12-2021
15:36:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-12-2021
15:36:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-12-2021
15:36:20ACV0PFEINFP6000 Data Entry:
RECOVERING/RESInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0942673
Page 218 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)OLVING
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-12-2021
15:36:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942674
Page 219 of 224
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-15-2020
13:13:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/15/2020Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942675
Page 220 of 224
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-18-2020
09:48:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Participant is willin
g to return for Vacc
ination 3
Participant is:
eligible and NO
T confirmed to h
ave received onl
y placebo at Vac
cination 1/2Transcription
Error
Dec-15-2020
13:13:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT
willing to return for
Vaccination 3 OR o
therwise not eligibl
eInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942676
Page 221 of 224
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-15-2020
13:13:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/15/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-15-2020
13:13:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942677
Page 222 of 224
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-20-2020
12:22:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-03-2020
13:38:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-03-2020
13:29:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-20-2020
12:22:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/20/2020Initial Entry
Sep-03-2020
13:38:30ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/3/2020Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942678
Page 223 of 224
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)
Sep-03-2020
13:29:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/3/2020Initial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942679
Page 224 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521316 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-30-2020
07:29:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2fd6\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0942680