Document text
Page 1 of 208
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 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
version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942967
Page 2 of 208
***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: 11521476 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/25/2020
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942968
Page 3 of 208
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11521476]
2.Birth Date: 1959
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0942969
Page 4 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942970
Page 5 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 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
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942971
Page 6 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942972
Page 7 of 208
***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: 11521476 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:[Gall Bladder Stones]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Aspirin Allergy]
Start Date: UNK/UNK/1985
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Penicillin Allergy]
Start Date: UNK/UNK/1970
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergy to black olives]
Start Date: UNK/UNK/1975
Ongoing: YES
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942973
Page 8 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gall Bladder Removal]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Breast Surgery for Fibrocystic Removal (left)]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Breast Surgery for Fibrocystic Removal (right)]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fibrocystic Left Breast]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942974
Page 9 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fibrocystic Right Breast]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942975
Page 10 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942976
Page 11 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
2.Weight: [129.6]
3.Unit: LB
4.Height: [59.0]
5.Unit: in
6.Body Mass Index: [26.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942977
Page 12 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942978
Page 13 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/25/2020
2.Randomization Number: [265209]
3.Randomization Group: [ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942979
Page 14 of 208
***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: 11521476 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/25/2020
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 [BP9K7H]
5.bSample ID [BP9K7G]
5.cSample ID [BNT39D]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942980
Page 15 of 208
***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: 11521476 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/25/2020
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 [BP0SH1]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942981
Page 16 of 208
***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: 11521476 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/25/2020 09:33
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942982
Page 17 of 208
***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: 11521476 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
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942983
Page 18 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942984
Page 19 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Oct/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942985
Page 20 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942986
Page 21 of 208
***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: 11521476 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:
Oct/15/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[BR920D barcode was taken in error and the sample will be destroyed.]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR920D]
5.bSample ID [BR9236]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942987
Page 22 of 208
***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: 11521476 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?YES
Date of First Delay:
Oct/15/2020
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESS
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location:
6.Body Side: Not Done Comments
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?Not Done Comments
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942988
Page 23 of 208
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/4/2020
2.Erroneous Visit
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942989
Page 24 of 208
***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, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 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:
Dec/4/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJN97]
5.bSample ID [BRJN98]
5.cSample ID [BS6K7D]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942990
Page 25 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942991
Page 26 of 208
***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: 11521476 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 [ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942992
Page 27 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942993
Page 28 of 208
***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: 11521476 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 [ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942994
Page 29 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942995
Page 30 of 208
***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: 11521476 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 [ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942996
Page 31 of 208
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942997
Page 32 of 208
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942998
Page 33 of 208
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 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 [ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0942999
Page 34 of 208
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11521476 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 [ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943000
Page 35 of 208
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
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?
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943001
Page 36 of 208
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943002
Page 37 of 208
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943003
Page 38 of 208
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: 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: 11521476 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 [ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943004
Page 39 of 208
***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: 11521476 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:
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943005
Page 40 of 208
***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: 11521476 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 [ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943006
Page 41 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: 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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943007
Page 42 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: UNPLANNED VISIT
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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943008
Page 43 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: CONTACT OUTCOME - UNPLANNED
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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Oct/29/2020
Contact Outcome:
VISIT ARRANGED
3.Comments: [Visit 2 vaccine was delayed. Subject returned for rescheduled Visit 2 today. Second
vaccine was canceled by sub-I.]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943009
Page 44 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Oct/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943010
Page 45 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Not Applicable
//Comments
2.Injection Site Location Not Applicable Comments
3.Injection Site Body Side: Not Applicable Comments
Reaction
4.aReaction: REDNESS
Reaction Present: Not Applicable Comments
4.bReaction: SWELLING
Reaction Present: Not Applicable Comments
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: Not Applicable Comments
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: Not Applicable Comments
5.cSymptom: HEADACHE
Symptom Present: Not Applicable Comments
5.dSymptom: VOMITING
Symptom Present: Not Applicable Comments
5.eSymptom: DIARRHEA
Symptom Present: Not Applicable Comments
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943011
Page 46 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5 fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: Not Applicable Comments
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: Not Applicable Comments
5.hSymptom: CHILLS
Symptom Present: Not Applicable Comments
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943012
Page 47 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 hearing loss right
ear Oct/14/2020 UNK:U
NK NO
End Date Time:
Oct/23/2020 UNK:UNK
Repeating
Pages
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943013
Page 48 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 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)[hearing loss right ear]
4.Start Date Time: Oct/14/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/23/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943014
Page 49 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943015
Page 50 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943016
Page 51 of 208
***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: 11521476 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[ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943017
Page 52 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
1. Repeating
Pages
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943018
Page 53 of 208
***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: 11521476 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: //
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943019
Page 54 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943020
Page 55 of 208
***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: 11521476 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?
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943021
Page 56 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943022
Page 57 of 208
***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: 11521476 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?
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943023
Page 58 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943024
Page 59 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943025
Page 60 of 208
***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: 11521476 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/15/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943026
Page 61 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943027
Page 62 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 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:
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943028
Page 63 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943029
Page 64 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 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?
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943030
Page 65 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943031
Page 66 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943032
Page 67 of 208
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943033
Page 68 of 208
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/23/2021
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943034
Page 69 of 208
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/23/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCMZZ]
5.bSample ID [BRCN00]
5.cSample ID [BS6KWG]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943035
Page 70 of 208
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/23/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMT3M]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943036
Page 71 of 208
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943037
Page 72 of 208
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Mar/10/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK2
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943038
Page 73 of 208
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Mar/10/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 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:
Mar/10/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [AA00003]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943039
Page 74 of 208
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943040
Page 75 of 208
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 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
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943041
Page 76 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943042
Page 77 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943043
Page 78 of 208
***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: 11521476 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: [ ]
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943044
Page 79 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/15/2020
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943045
Page 80 of 208
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 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
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943046
Page 81 of 208
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 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
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943047
Page 82 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormSep-25-2020 15:27:30 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943048
Page 83 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Sep-25-2020 15:45:37 (UTC-08:00) Pacific Time
(US & Canada)Post-menopausal 2004
Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943049
Page 84 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormOct-21-2020 19:11:19 (UTC-08:00) Pacific Time
(US & Canada)sUBJECT IS OVER 60 AND POST
MENOPAUSAL
Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943050
Page 85 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Oct-21-2020 19:11:19 (UTC-08:00) Pacific Time
(US & Canada)sUBJECT IS OVER 60 AND POST
MENOPAUSAL
Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943051
Page 86 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Oct-21-2020 19:11:19 (UTC-08:00) Pacific Time
(US & Canada)sUBJECT IS OVER 60 AND POST
MENOPAUSAL
Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943052
Page 87 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Oct-21-2020 19:11:19 (UTC-08:00) Pacific Time
(US & Canada)sUBJECT IS OVER 60 AND POST
MENOPAUSAL
Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943053
Page 88 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Oct-21-2020 19:11:19 (UTC-08:00) Pacific Time
(US & Canada)sUBJECT IS OVER 60 AND POST
MENOPAUSAL
Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943054
Page 89 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Oct-21-2020 19:11:19 (UTC-08:00) Pacific Time
(US & Canada)sUBJECT IS OVER 60 AND POST
MENOPAUSAL
Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943055
Page 90 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aOct-21-2020 19:11:19 (UTC-08:00) Pacific Time
(US & Canada)sUBJECT IS OVER 60 AND POST
MENOPAUSAL
Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943056
Page 91 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aOct-21-2020 19:11:19 (UTC-08:00) Pacific Time
(US & Canada)sUBJECT IS OVER 60 AND POST
MENOPAUSAL
Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943057
Page 92 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aOct-21-2020 19:11:19 (UTC-08:00) Pacific Time
(US & Canada)sUBJECT IS OVER 60 AND POST
MENOPAUSAL
Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943058
Page 93 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Oct-28-2020 08:23:51 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943059
Page 94 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6Oct-28-2020 08:24:05 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943060
Page 95 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
11Oct-28-2020 08:24:17 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943061
Page 96 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormNov-03-2020 07:04:17 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943062
Page 97 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Nov-03-2020 07:04:17 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943063
Page 98 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Nov-03-2020 07:04:17 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943064
Page 99 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Nov-03-2020 07:04:17 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943065
Page 100 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4.aNov-03-2020 07:04:17 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943066
Page 101 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4.bNov-03-2020 07:04:17 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943067
Page 102 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.aNov-03-2020 07:04:17 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943068
Page 103 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.bNov-03-2020 07:04:17 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943069
Page 104 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.cNov-03-2020 07:04:17 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943070
Page 105 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.dNov-03-2020 07:04:17 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943071
Page 106 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.eNov-03-2020 07:04:17 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943072
Page 107 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.fNov-03-2020 07:04:17 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943073
Page 108 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.gNov-03-2020 07:04:17 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943074
Page 109 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5.hNov-03-2020 07:04:17 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943075
Page 110 of 208
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 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 Jan-30-2021 14:55:29 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Donald Brandon Approved Jan-21-2021 11:27:28 (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-04-2020 10:45:47 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Donald Brandon Approved Nov-17-2020 12:38:51 (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 Nov-16-2020 19:43:23 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943076
Page 111 of 208
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Affidavit:
N/A
Donald Brandon Approved Nov-16-2020 12:28:44 (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 Nov-16-2020 06:43:01 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Donald Brandon Approved Nov-13-2020 09:59:18 (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 Nov-12-2020 14:35:25 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Donald Brandon Approved Nov-06-2020 08:52:50 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943077
Page 112 of 208
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 Nov-06-2020 07:30:17 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Donald Brandon Approved Nov-04-2020 12:47:50 (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 Nov-04-2020 06:30:42 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Donald Brandon Approved Nov-03-2020 16:27:04 (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.
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943078
Page 113 of 208
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 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-25-2020 15:26:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-25-2020 15:26:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943079
Page 114 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-25-2020 15:26:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/25/2020Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943080
Page 115 of 208
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-25-2020 15:25:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11521476Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-25-2020 15:25:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1959Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-25-2020 15:27:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-25-2020 15:27:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-25-2020 15:27:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943081
Page 116 of 208
***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: 11521476 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-25-2020 15:27:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943082
Page 117 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 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-25-2020 15:27:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-25-2020 15:27:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-25-2020 15:27:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943083
Page 118 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Sep-25-2020 15:30:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:Gall Bladder Sto
nes
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2
001Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-25-2020 15:30:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 15:30:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Gall Bladder StonesInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-25-2020 15:30:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-25-2020 15:30:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2001Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943084
Page 119 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b
Date Location User Value Reason
Sep-25-2020 15:32:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 2
Medical History Te
rm:Aspirin Allerg
y
Start Date: UNK/UNK/1
985
Ongoing: YESTranscription Error
Sep-25-2020 15:31:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Aspirin Allergy
Start Date: UNK/UNK/198
5
Ongoing: NO
End Date:
UNK/UNK/
1985Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943085
Page 120 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Line/MH Number:
Date Location User Value Reason
Sep-25-2020 15:31:10
(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-25-2020 15:31:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aspirin AllergyInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-25-2020 15:31:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-25-2020 15:32:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESTranscription Error
Sep-25-2020 15:31:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1985Initial Entry
1.c
Date Location User Value Reason
Sep-25-2020 15:31:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:Penicillin Aller
gy
Start Date: UNK/UNK/197
0
Ongoing: YESInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943086
Page 121 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.c Line/MH Number:
Date Location User Value Reason
Sep-25-2020 15:31:49
(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-25-2020 15:31:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Penicillin AllergyInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-25-2020 15:31:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1970Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-25-2020 15:31:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-28-2020 08:23:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:4
Medical History
Term:allergy to black
olives
Start Date: UNK/UNK/197
5
Ongoing: YESChanged Information
Sep-25-2020 15:32:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:Black Olives
Start Date: UNK/UNK/19
75Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943087
Page 122 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Ongoing: YES
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943088
Page 123 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.d Line/MH Number:
Date Location User Value Reason
Sep-25-2020 15:32:37
(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-28-2020
10:41:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Sep-28-2020
08:23:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dChanged
Information
Sep-28-2020
08:23:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
allergy to black ol
ivesChanged
Information
Sep-25-2020
23:24:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Opened Clarify BLACK
OLIVES as
follows...Are you
reporting
ALLERGY TO
BLACK OLIVES?
BLACK OLIVES
CAUSE
INDIGESTION?
or Other? If so
please edit as such,
Otherwise, clarify
further. Thank you.
Sep-25-2020
15:32:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Black OlivesInitial Entry
1.d Start Date:
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943089
Page 124 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-25-2020 15:32:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1975Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-25-2020 15:32:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-25-2020 15:33:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:Gall Bladder Rem
oval
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/20
01Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943090
Page 125 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.e Line/MH Number:
Date Location User Value Reason
Sep-25-2020 15:33:23
(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-25-2020 15:33:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Gall Bladder RemovalInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-25-2020 15:33:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-25-2020 15:33:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2001Initial Entry
1.f
Date Location User Value Reason
Sep-25-2020 15:35:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:6
Medical Hi
story Term
:Breast Surgery for Fib
rocystic Removal (left
)
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005Changed Information
Sep-25-2020 15:35:35
(UTC-08:00) Pacific TimeACV0PFEINFP6000 Data Entry: New Information
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0943091
Page 126 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US & Canada) Line/MH N
umber:6
Medical Hi
story Term:Breast Surgery for Fib
rocystic Removal (left
)
Start Date: UNK/UNK/2005
Ongoing: YES
Sep-25-2020 15:34:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:Breast Surgery for Fi
brocystic Removal
Start Date: UNK/UNK/2005
Ongoing: YESInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943092
Page 127 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.f Line/MH Number:
Date Location User Value Reason
Sep-25-2020 15:34:43
(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-25-2020 15:35:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Breast Surgery for Fibrocystic Rem
oval (left)New Information
Sep-25-2020 15:34:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Breast Surgery for Fibrocystic Rem
ovalInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-25-2020 15:34:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-25-2020 15:35:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Changed Information
Sep-25-2020 15:34:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-25-2020 15:36:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:7
Medical Hi
story Term
:Breast Surgery for Fibr
ocystic Removal (right
)New Information
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943093
Page 128 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
Sep-25-2020 15:35:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:7
Medical His
tory Term:Breast Surgery for Fi
brocystic Removal
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943094
Page 129 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.g Line/MH Number:
Date Location User Value Reason
Sep-25-2020 15:35:15
(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-25-2020 15:36:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Breast Surgery for Fibrocystic Rem
oval (right)New Information
Sep-25-2020 15:35:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Breast Surgery for Fibrocystic Rem
ovalInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-25-2020 15:35:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-25-2020 15:35:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
1.h
Date Location User Value Reason
Sep-25-2020 15:38:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8
Medical History
Term:Fibrocystic Left B
reast
Start Date: UNK/UNK/2005Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943095
Page 130 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Ongoing: NO
End Date:
UNK/UNK/20
05
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943096
Page 131 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.h Line/MH Number:
Date Location User Value Reason
Sep-25-2020 15:38:02
(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-25-2020 15:38:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Fibrocystic Left BreastInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-25-2020 15:38:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-25-2020 15:38:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.i
Date Location User Value Reason
Sep-25-2020 15:38:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:Fibrocystic Right
Breast
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/199
0Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943097
Page 132 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.i Line/MH Number:
Date Location User Value Reason
Sep-25-2020 15:38:42
(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-25-2020 15:38:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Fibrocystic Right BreastInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-25-2020 15:38:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-25-2020 15:38:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943098
Page 133 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-25-2020 15:43:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be HI
V POSITIVEInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943099
Page 134 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020 15:44:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-25-2020 15:44:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
129.6Initial Entry
3. Unit:
Date Location User Value Reason
Sep-25-2020 15:44:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-25-2020 15:44:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
59.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-25-2020 15:44:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-25-2020 15:44:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
26.2Initial Entry
7.a
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943100
Page 135 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-25-2020 15:44:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.9
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-25-2020 15:44:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-25-2020 15:44:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
97.9Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-25-2020 15:44:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-25-2020 15:44:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943101
Page 136 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
3. Collection Date:
Date Location User Value Reason
Sep-25-2020 15:45:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-25-2020 15:45:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-25-2020 15:45:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-25-2020 15:45:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-25-2020 15:45:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943102
Page 137 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-25-2020 15:49:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-25-2020 15:49:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
265209Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943103
Page 138 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 15:49:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 15:49:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020 08:44:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-26-2020 02:36:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-25-2020 15:49:24
(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-25-2020 15:49:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020 08:44:13 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)
(6)
(b)
(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943104
Page 139 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific Time
(US & Canada)Sample ID: BP9K7H
5.a Sample ID
Date Location User Value Reason
Sep-28-2020 08:44:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP9K7HInitial Entry
5.b
Date Location User Value Reason
Sep-28-2020 08:44:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9K7GInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-28-2020 08:44:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP9K7GInitial Entry
5.c
Date Location User Value Reason
Sep-28-2020 18:10:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNT39DInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-28-2020 18:10:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNT39DInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943105
Page 140 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 15:49:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 15:49:32
(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-28-2020 08:09:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-26-2020 02:36:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-25-2020 15:49:32
(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-25-2020 15:49:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020 08:09:29 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)
(6)
(b)
(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943106
Page 141 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific Time
(US & Canada)Sample ID: BP0SH1
5.a Sample ID
Date Location User Value Reason
Sep-28-2020 08:09:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP0SH1Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943107
Page 142 of 208
***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: 11521476 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-25-2020 15:49:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020 15:49:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020 15:49:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-25-2020 15:49:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020 09:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020 15:49:49
(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-25-2020 15:49:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943108
Page 143 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-25-2020 15:49:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-25-2020 15:49:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-25-2020 15:49:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943109
Page 144 of 208
***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: 11521476 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-25-2020 15:50:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943110
Page 145 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-07-2020
02:54:08
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: ClosedResponse satisfies query
Nov-06-2020
13:05:56
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2
: ClosedAuto closed by Validation
Check: VC_SV001_04_AN
Nov-06-2020
07:32:56
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Answe
redI was instructed in a
previous query to complete
the FUP form. I would not
have completed the FUP
form had I not been
erroneously instructed to do
so.
Nov-06-2020
07:22:20
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Reissu
ed:Ope
nedDate on DISPOSITION
FOLLOW UP CRF should
be the date at which
subjects ends the STUDY.
Date on DISPOSITION
TREATMENT CRF should
be the date at which subject
ends the
TREATMENT/STUDY
DRUG. Please review and
update for all dates to be in
logical order.
Nov-06-2020
07:20:54
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redMy apologies, but I just
cannot understand this
run-on sentence. The
subject will continue in the
study per protocol, as
previously indicated. Please
clarify if this does not
answer the query.
Nov-06-2020 ACV0PFEINFP6000 Query 1 DM2: Subject discontinued
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943111
Page 146 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
00:58:13
(UTC-08:00)
Pacific Time
(US &
Canada): Reissu
ed:Ope
nedtreatment as soon as
Vaccination 1 received on
25SEP2020. Please confirm
if subject is in follow up
status if Yes, the follow up
form is not expected to
enter now if not update FUP
date when subject disagree
to be in FUP.
Nov-05-2020
08:46:28
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redThe same question gets the
same answer. Sorry.
Nov-05-2020
01:27:37
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Ope
nedV2 DOV 15Oct2020 is after
the DISPOSITION -
FOLLOW-UP date
25Sep2020 under
Follow-up (FUP) visit.
Please correct or clarify.
Nov-04-2020
16:52:41
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Answe
redWhat do you want here?
Isn't the Date of Completion
the date of the final
vaccine?
Nov-04-2020
14:54:01
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2
: Opene
dDMW5284890;‘Date of
Visit' is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Nov-04-2020
06:38:44
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redIsn't the date of completion
the date of the last vaccine?
Even if the last vaccine was
the FIRST vaccine? If not,
what SHOULD it be?
Nov-04-2020
06:30:42
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1
: Opene
dDate of Visit is after the
Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943112
Page 147 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-21-2020
19:09:08
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
Oct/15/
2020Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943113
Page 148 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Nov-05-2020
21:44:12
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: ClosedResponse satisfies query
Nov-05-2020
08:48:28
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redTreatment ended with the
first vaccine, since she had
no second vaccine. The
subject had not ended the
study - she will continue as
per protocol, only having
had one vaccination.
Nov-05-2020
00:25:40
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Ope
nedThe date on form
DISPOSITION -
TREATMENT at EOT visit
should be a date of when
the TREATMENT ended.
The date on form
DISPOSITION -
FOLLOW-UP at visit
named FUP should be a
date of when the subject
ended the STUDY. Please
update accordingly or
clarify.
Nov-04-2020
16:52:54
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redWhat do you want here?
Isn't the Date of Completion
the date of the final
vaccine?
Nov-04-2020
14:54:01
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1
: Opene
dDMW5284889;Date is after
‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Oct-21-2020
19:09:57
(UTC-08:00)ACV0PFEINFP6000 Data E
ntry:
Oct/15/Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943114
Page 149 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time
(US &
Canada)2020
2.a
Date Location User Value Reason
Oct-21-2020 19:09:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.0
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-21-2020 19:09:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-21-2020 19:09:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.0Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-21-2020 19:09:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-21-2020 19:09:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943115
Page 150 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-21-2020 19:11:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-21-2020 19:11:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-21-2020 19:11:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-21-2020 19:11:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-21-2020 19:11:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-21-2020 19:11:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defined Ident
ifier:Not Applica
ble
Test:: Not Applica
bleInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943116
Page 151 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Result:: Not Applica
ble
Not Done:: Not Applica
ble
6.a Sponsor ID:
Date Location User Value Reason
Oct-21-2020 19:11:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-21-2020 19:11:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-21-2020 19:11:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-21-2020 19:11:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943117
Page 152 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 18:19:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 18:19:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-17-2020 12:45:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 5: Closed Response satisfies
query
Nov-17-2020 09:45:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 5: Answered OK. However, if this
query had been
entered on line 2,
where the correction
was needed, it could
have been answered in
one step. Instead, I had
to make the correction
and then come back
here to answer the
query. DOUBLE
WORK!
Nov-17-2020 04:02:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 5: Reissued:Opened DM: Per completion
requirement, Enter a
comment in the item
‘If no sample was
collected or sample
was not collected
according to protocol,
please provide reason’
indicating BR920D
barcode was taken in
error and that the
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0943118
Page 153 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
sample will be
destroyed.
Nov-17-2020 04:01:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 4: Closed As per the update
Nov-16-2020 19:44:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 5: Answered BR920D WAS SENT
IN ERROR.
SUBJECT VISIT 2
DELAYED UNTIL
10/29/20 WILL
SUBMITT REQUEST
FOR DESTRUCTION
Nov-16-2020 19:43:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Opened There are more than 1
barcode present for
sample collection.
Please review and
correct as appropriate.
Nov-16-2020 19:39:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 4: Answered UNFREEZE.
SUBJECT'S VISIT 2
WAS DELAYED
UNTIL 29 OCT 20.
WILL SUBMIT
REQUEST FOR
DESTRUCTION FOR
THIS SAMPLE
Nov-10-2020 08:21:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 4: Opened HOLDS: Nasal swab
BR9236 was received
by the lab for Visit 2.
Please review and
update or submit
updated SCF.
Nov-10-2020 08:21:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed re-query
Nov-10-2020 08:21:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opened HOLDS: Nasal swab
BR9236 was received
by the lab for
COVID_A. Please
review and update or
submit updated SCF.
Nov-03-2020 03:43:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0943119
Page 154 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-24-2020 04:20:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Sandip
Namdeorao
SuryawanshiQuery 2: Reissued:Candidate subject met delay of
vaccination. Kindly
verify and update data
once subject
completes vaccination.
Thank you.
Oct-23-2020 16:05:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered That can't be
completed until the
participant received
the vaccine
Oct-22-2020 22:56:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM1: Response says
completed. However
still data is not
updated in Vaccination
form. Kindly consider
to update the data in
all forms under this
visit. Thank you.
Oct-21-2020 19:13:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered COMPLETED
Oct-21-2020 01:50:30
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: Kindly consider
to update rest of the
forms under this visit
or else clarify. Thank
you.
Oct-15-2020 18:19:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 18:19:45
(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.
Oct-15-2020 18:19:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)
(6)
(b)(4),(b)(6)
(b)(4),(b)
(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943120
Page 155 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nov-17-2020 09:42:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR920D barcode was taken in error a
nd the sample will be destroyed.Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020 18:19:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR920DInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 18:19:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR920DInitial Entry
5.b
Date Location User Value Reason
Nov-16-2020 19:43:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR9236Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-16-2020 19:43:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR9236Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943121
Page 156 of 208
***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: 11521476 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
Oct-15-2020 15:01:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of First Delay:
Oct/15/2020
Reason(s) for Temporary Delay of V
accination
FEVER OR ACUTE ILLNESSInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Nov-06-2020
01:18:34
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Nov-04-2020
16:53:45
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredI assume this is an auto-query,
as the reason is clear if the
form is reviewed.
Nov-04-2020
14:54:01
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5284856;Randomization
number is recorded and the
final disposition date is
present on the Disposition -
Follow-up eCRF, but there is
no dosing date present on the
Treatment eCRF. Please
review and update as
appropriate.
Oct-28-2020
08:23:51
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Not D
oneInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)
(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943122
Page 157 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
6. Body Side:
Date Location User Value Reason
Oct-28-2020 08:24:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-28-2020 08:24:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943123
Page 158 of 208
***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, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 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-04-2020 10:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/4/2020Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943124
Page 159 of 208
***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, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-04-2020 10:45:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-04-2020 10:45:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-04-2020 17:37:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-04-2020 10:45:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-04-2020 10:45:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/4/2020Initial Entry
5.a
Date Location User Value Reason
Dec-04-2020 17:37:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRJN97Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-04-2020 17:37:41 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943125
Page 160 of 208
***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, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific Time
(US & Canada)BRJN97
5.b
Date Location User Value Reason
Dec-04-2020 17:37:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRJN98Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-04-2020 17:37:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BRJN98Initial Entry
5.c
Date Location User Value Reason
Dec-04-2020 17:38:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS6K7DInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-04-2020 17:38:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BS6K7DInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943126
Page 161 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: 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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-07-2020
03:22:36
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Sandip Namdeorao
SuryawanshiQuery 1
: Closedclosed as data is removed
from Disposition follow up.
Nov-06-2020
07:27:42
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redSome previous query told
me to complete the FUP
form, so I did. Apparently
that instruction was
incorrect. I would not have
completed that eCRF had I
not been erroneously
instructed to do so.
Nov-06-2020
07:12:04
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Ope
nedDate on DISPOSITION
FOLLOW UP CRF should
be the date at which
subjects ends the STUDY.
Date on DISPOSITION
TREATMENT CRF should
be the date at which subject
ends the
TREATMENT/STUDY
DRUG. Please review and
update for all dates to be in
logical order.
Nov-05-2020
00:00:40
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: ClosedRelated query present
Nov-04-2020
16:54:17
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Answe
redWhat do you want here?
Isn't the Date of Completion
the date of the final
vaccine?
Nov-04-2020 ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2 DMW5284891;‘Date of
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)
(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943127
Page 162 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: 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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14:54:01
(UTC-08:00)
Pacific Time
(US &
Canada): Opene
dVisit' is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Nov-04-2020
06:38:15
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redIsn't the date of completion
the date of the last vaccine?
Even if the last vaccine was
the FIRST vaccine? If not,
what SHOULD it be?
Nov-04-2020
06:30:42
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1
: Opene
dDate of Visit is after the
Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
Nov-03-2020
06:59:29
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
Oct/29/
2020Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943128
Page 163 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: UNPLANNED VISIT - 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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Assessments
Date Location User Value Reason
Nov-03-2020 07:03:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-03-2020 06:59:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update as
appropriate.
Nov-03-2020 06:59:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943129
Page 164 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: CONTACT OUTCOME - UNPLANNED - 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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Contact Type:
Date Location User Value Reason
Nov-03-2020 07:02:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Nov-04-2020 21:50:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Vitals updated
Nov-04-2020 06:27:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Please review, as this
query is incorrect.
Nov-04-2020 04:10:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened PDQ : Contact
Outcome' is selected
as 'VISIT
ARRANGED' but no
'VITAL SIGNS' and/or
'UNPLANNED
ASSESSMENT OF
LOCAL REACTION'
form(s) is/are entered.
Please review and
update as appropriate.
Nov-03-2020 07:03:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-03-2020 07:03:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Oct/29/2020
Contact Outcome:
VISIT ARRANGEDNew Information
Nov-03-2020 07:02:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Contact Outcome' is
selected as 'VISIT
ARRANGED' but no
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943130
Page 165 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: CONTACT OUTCOME - UNPLANNED - 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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
'VITAL SIGNS' and/or
'UNPLANNED
ASSESSMENT OF
LOCAL REACTION'
form(s) is/are entered.
Please review and
update as appropriate.
Nov-03-2020 07:02:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "Date of
Contact" is missing.
Nov-03-2020 07:02:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Contact Outcome:
VISIT ARRANGEDInitial Entry
3. Comments:
Date Location User Value Reason
Nov-03-2020 07:02:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Visit 2 vaccine was delayed. Subject r
eturned for rescheduled Visit 2 today.
Second vaccine was canceled by sub-
I.Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943131
Page 166 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Nov-06-2020
13:05:37
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1
: ClosedAuto closed by Validation
Check: VC_VS001_05_AN
Nov-05-2020
08:50:15
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redThe same question gets the
same answer. Sorry.
Nov-04-2020
22:00:32
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Ope
nedDM : Date of
Completion/Discontinuation
/Death (25/Sep/2020) on
EOT is prior to Date of visit
(5/Sep/2020) on VITAL
TEMP CRF. Please review
and update. Else, clarify.
Nov-04-2020
16:54:50
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redWhat do you want here?
Isn't the Date of Completion
the date of the final
vaccine?
Nov-04-2020
14:54:01
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1
: Opene
dDMW5284888;Date is after
‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Nov-03-2020
07:03:54
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
Oct/29/
2020Initial Entry
2.a
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943132
Page 167 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Nov-03-2020 07:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.5
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-03-2020 07:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-03-2020 07:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.5Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-03-2020 07:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-03-2020 07:03:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943133
Page 168 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-05-2020
08:57:21
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Clo
sedClose per query
response
Nov-04-2020
06:29:37
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: An
sweredSubject did not
receive a vaccine at
this visit, so how can
it be anything but
"Not Applicable"?
What SHOULD be
entered here if this is
not applicable?
Nov-03-2020
21:05:32
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: Op
enedDMW5269439;Date
of Assessment is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or
clarify
Nov-03-2020
07:04:17
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not Applica
bleInitial Entry
2. Injection Site Location
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Injection Site Body Side:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943134
Page 169 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.a
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Reaction:: Not Applicable
Reaction Present:: Not ApplicableInitial Entry
4.a Reaction:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4.a Reaction Present:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4.b
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Reaction:: Not Applicable
Reaction Present:: Not ApplicableInitial Entry
4.b Reaction:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4.b Reaction Present:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943135
Page 170 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: Not Applicable
Symptom Present:: Not ApplicableInitial Entry
5.a Symptom:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.a Symptom Present:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.b
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: Not Applicable
Symptom Present:: Not ApplicableInitial Entry
5.b Symptom:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.b Symptom Present:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.c
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific TimeACV0PFEINFP6000 Data Entry:
Symptom:: Not ApplicableInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0943136
Page 171 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US & Canada) Symptom Present:: Not Applicable
5.c Symptom:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.c Symptom Present:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.d
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: Not Applicable
Symptom Present:: Not ApplicableInitial Entry
5.d Symptom:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.d Symptom Present:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.e
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: Not Applicable
Symptom Present:: Not ApplicableInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943137
Page 172 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.e Symptom:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.e Symptom Present:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.f
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: Not Applicable
Symptom Present:: Not ApplicableInitial Entry
5.f Symptom:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.f Symptom Present:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.g
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: Not Applicable
Symptom Present:: Not ApplicableInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943138
Page 173 of 208
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.g Symptom:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.g Symptom Present:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.h
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: Not Applicable
Symptom Present:: Not ApplicableInitial Entry
5.h Symptom:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.h Symptom Present:
Date Location User Value Reason
Nov-03-2020 07:04:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943139
Page 174 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Oct-16-2020 12:15:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943140
Page 175 of 208
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 12:15:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 12:15:08
(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
Feb-07-2021 13:41:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-05-2021 16:31:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered CONFIRMED NO
PAST HISTORY OF
SAME.
Feb-05-2021 08:17:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened clinical: pls confirm
subject has no past
history of hearing loss,
episodes of hearing
loss or other ear
problems or update
MedHx CRF
accordingly. Thanks
Feb-02-2021 14:25:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-02-2021 14:08:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered 60 MG QD FOR 7
DAYS.
Feb-02-2021 06:48:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened clinical: Thanks, what
dose and duration of
prednisone was given?
Feb-01-2021 14:55:00
(UTC-08:00) Pacific TimeACV0PFEINFP6000 Query 1: Answered THIS IS BASED ON
SUBJECT SELF
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0943141
Page 176 of 208
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US & Canada) REPORT.
PREDNISONE WAS
GIVEN.
Feb-01-2021 05:19:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened clinical: thanks, but
pls confirm hearing
back to normal and if
this is based on
audiometry results or
subject self report.
What treatment did
subject receive?
Jan-30-2021 14:54:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered RESOLVED. THANK
YOU.
Jan-25-2021 05:17:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened clinical: pls confirm
hearing is back to
normal, advise if
audiometry done and
if so what were the
results. Advise what
treatment the subject
received. Thanks.
Oct-16-2020 12:15:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hearing loss right earInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-06-2020
12:41:12
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2
: ClosedAuto closed by Validation
Check: VC_AE001_09_AN
Nov-06-2020
07:23:47
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Answe
redSubject discontinued study
treatment, but did not
discontinue from study
follow-up. Another query
told me to enter information
on the FUP form. Was that
incorrect?
Nov-06-2020
02:49:11
(UTC-08:00)ACV0PFEINFP6000 Query 2
: Reissu
ed:OpePlease review date at which
subject discontinued the
study on FUP
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943142
Page 177 of 208
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time
(US &
Canada)ned DISPOSITION CRF
(currently 25Sep2020), as it
occurs before this AE start
date (currently 14Oct2020).
And correct, or clarify.
Nov-05-2020
21:45:46
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: ClosedResponse satisfies query
Nov-05-2020
08:49:35
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Answe
redThe same question gets the
same answer. Sorry.
Nov-05-2020
08:49:17
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redThe same question gets the
same answer. Sorry.
Nov-04-2020
22:04:10
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Ope
nedDM : Date of
Completion/Discontinuation
/Death (25/Sep/2020) on
EOT is prior to AE Start
Date (14/Oct/2020). Please
review and update. Else,
clarify. Kindly contact CRA
for further assistance.
Nov-04-2020
22:02:20
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Reissu
ed:Ope
nedDM : Date of
Completion/Discontinuation
/Death (25/Sep/2020) on
EOT is prior to AE Start
Date (14/Oct/2020). Please
review and update. Else,
clarify.
Nov-04-2020
16:50:35
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Answe
redWhat do you want here?
Isn't the Date of Completion
the date of the final
vaccine?
Nov-04-2020 ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2 DMW5284868;Start Date'
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943143
Page 178 of 208
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14:37:37
(UTC-08:00)
Pacific Time
(US &
Canada): Opene
dis after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Nov-04-2020
06:36:24
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redShouldn't the date of
completion be the date of
the last vaccine? Even if the
last vaccine is the ONLY
vaccine? If not, what
SHOULD it be?
Nov-04-2020
03:23:20
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Ope
nedDM : Date of
Completion/Discontinuation
/Death on EOT (25/Sep
/2020) is prior to the AE
Start Date (14/Oct/2020).
Please review and update
the data as appropriate.
Else,clarify.
Nov-02-2020
07:12:27
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redPlease read previous
answer. You have asked the
exact same question, and
thus, the same answer is
still correct.
Nov-02-2020
05:27:35
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Ope
nedDM: The Latest Action to
Study Treatment is DRUG
WITHDRAWN, but the
Start Date (14/Oct/2020) of
this AE is AFTER the Date
of
Completion/Discontinuation
/Death (25/Sep/2020) on
Disposition-Treatment
Form. Please review and
update as appropriate.
Oct-30-2020
08:35:15
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redWhat? The subject was
discontinued = no second
vaccine, due to the AE. So
the last vaccine was the first
vaccine. How else should
this be recorded?
Oct-30-2020
00:42:08
(UTC-08:00)
Pacific TimeACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1
: Opene
dDMW5220375;The Latest
Action to Study Treatment
is DRUG WITHDRAWN,
but the Start Date of this AE
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943144
Page 179 of 208
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US &
Canada)is AFTER the Date of
Completion/Discontinuation
/Death on Disposition-
Treatment Form. Please
review and update as
appropriate.
Oct-16-2020
12:15:08
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
Oct/14/
2020 U
NK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-06-2020
13:05:17
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 3
: ClosedAuto closed by Validation
Check: VC_AE001_10_AN
Nov-04-2020
16:51:11
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 3
: Answe
redI answered this on that
form, more than once. What
do you want here? Isn't the
Date of Completion the date
of the final vaccine?
Nov-04-2020
14:54:01
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 3
: Opene
dDMW5284850;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Nov-01-2020
10:30:26
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Closedclinical: Thanks
Oct-31-2020
13:55:44
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Answe
redYES. THE SUBJECT WAS
ON DISABILITY ONLY
FOR HER HEARING
LOSS.
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943145
Page 180 of 208
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-31-2020
09:48:04
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Reissu
ed:Ope
nedclinical: please confirm the
short term disability was
specifically due to hearing
loss and no other issue.
Thanks
Oct-30-2020
16:34:40
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Answe
redYes, this was short term
disability. We are waiting
on medical records.
Oct-29-2020
06:25:49
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Reissu
ed:Ope
nedclinical: Pls confirm reason
for disability was because
of hearing loss and advise if
this was short term
disability since hearing
restored. Pls also advise
what specific testing done
to document hearing
loss/recovery ie audiometry.
Thanks
Oct-28-2020
17:23:03
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Answe
redYes. Subject has her hearing
restored
Oct-28-2020
06:21:14
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Opene
dclinical: pls confirm hearing
loss has completely
resolved. Thanks
Oct-26-2020
11:16:59
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
NO
End D
ate Ti
me:
Oct/
23/2
020
UN
K:U
NKNew Information
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943146
Page 181 of 208
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-26-2020
06:27:37
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: ClosedResponse satisfies query
Oct-23-2020
16:07:58
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redYes. She is improving but
still on disability. Will
update when resolved
Oct-21-2020
12:00:46
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Opene
dClinQuery: Please verify if
Hearing Loss Right Ear is
ongoing, then update the
END DATE and
OUTCOME as appropriate.
Oct-16-2020
12:15:08
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-16-2020 12:15:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial 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).
Date Location User Value Reason
Oct-16-2020 12:15:08
(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.
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943147
Page 182 of 208
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Oct-16-2020 12:15:08
(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
Oct-27-2020 06:22:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Juleen
GayedQuery 2: Closed Response satisfies
query
Oct-26-2020 12:00:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered The PI feels the IP
may have cause the
inflammatory reaction.
He can't rule it out
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943148
Page 183 of 208
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-26-2020 08:16:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Juleen Gayed Query 2: Opened Clin: Please confirm
if you have received
more information to
clarify if this is still
considered related
Oct-26-2020 06:19:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-23-2020 16:06:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered This could be a
delayed immune
response. We are
waiting for more
information from her
doctor before the PI
can say it is not
related.
Oct-21-2020 12:03:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Causality
is noted as Related to
Study Treatment.
However Study
Treatment was given
more than 2 weeks
prior to this AE.
Please confirm if this
AE is truly related to
study treatment, then
update the CRF
accordingly.
Oct-16-2020 12:15:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-29-2020 11:35:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-29-2020 07:52:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered OK. Thank you.
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943149
Page 184 of 208
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-29-2020 07:07:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Since
Drug Withdrawn is
marked, please
complete the EOT
CRF as appropriate.
Oct-26-2020 12:01:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNNew Information
Oct-16-2020 12:15:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-30-2021 14:55:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESChanged Information
Oct-16-2020 12:15:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 12:15:08
(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
Oct-26-2020 11:17:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-26-2020 11:17:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Oct-26-2020 11:16:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE hearing loss
right ear: Response to
"What was the
outcome of this
adverse event?" is
'Not Recovered/Not
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943150
Page 185 of 208
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Resolved' but AE End
Date/Time is present.
Oct-16-2020 12:15:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020 12:31:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-16-2020 06:43:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered OK. I hope this does
not result in more and
more queries . . .
Nov-16-2020 06:43:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOOK. I hope this does
not result in more and
more queries . . .
Nov-14-2020 06:47:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened IF the subject did
NOT discontinue the
study, then question
"Did the adverse event
cause the subject to be
discontinued from the
study?" should be NO.
Please update
response.
Nov-12-2020 13:13:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Candidate Sent to Triad team to
review.
Nov-11-2020 06:33:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Please read previous
response. I am not
going to complete the
FUP form again only
to be told to remove it
because the subject
did NOT
DISCONTINUE THE
STUDY. I believe the
query is WRONG.
Please review.
Nov-11-2020 01:55:48 ACV0PFEINFP6000 Query 2: Reissued:Opened DM: As response to
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)
(4),
(b)(6)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)(4),(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943151
Page 186 of 208
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific Time
(US & Canada)'Did the adverse event
cause the subject to be
discontinued from the
study?' is marked as
YES. Therefore,
please complete
disposition follow up
CRF with the reason
indicating as adverse
event. Thank you.
Nov-10-2020 10:17:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered I already did that and
then had to change it.
I entered yes here due
to the previous query.
I will not change this
over and over, so
please decide how this
should be done and I
will do that one last
time. Thank you.
Nov-09-2020 23:14:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 2: Opened Did the adverse event
cause the subject to be
discontinued from the
study? is marked as
YES, hence please
complete disposition
follow up CRF with
the reason indicating
as adverse event. If
subject not
discontinued from
study due to this AE,
update to NO
Nov-09-2020 23:12:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 1: Closed Invalid query, new
query raised
Nov-07-2020 05:30:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate Please review and
action as appropriate.
Nov-05-2020 08:52:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Isn't the end of
treatment the day of
the last vaccination if
subject did not have a
second vaccine? I
don't know what to
enter here.
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943152
Page 187 of 208
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nov-05-2020 00:06:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened You are welcome.
Please check date
entered on FUP
DISPOSITION CRF
(currently 25Sep2020)
as it doesn't
correspond to the AE
dates (currently
14Oct2020). And
correct, or clarify.
Nov-04-2020 06:34:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered OK. Thank you. It is
very helpful to list the
NAME of the eCRF
as it is listed in the
header. Until the page
is opened, you don't
see the the actual
eCRF name if it is
different. (I.E.:
DISPOSITION -
FOLLOW-UP only
shows up as FUP in
the header.)
Nov-04-2020 00:33:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened AE start date is after
DISPOSITION -
TREATMENT date,
hence DISPOSITION
- FOLLOW-UP under
Follow-up (FUP) visit
is required. If the
Participant,
discontinues after the
treatment period,
select the status
accordingly.
Nov-03-2020 05:47:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered I don't find any forms
with the names you
list here. However, the
EOT page is
completed with AE
listed as the reason, so
this query is incorrect.
If there is another
page we need to
complete, please
indicate the actual
name of the page.
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943153
Page 188 of 208
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nov-03-2020 03:46:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Did the adverse event
cause the subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Oct-29-2020 07:54:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Did the adverse event
cause the subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Oct-29-2020 07:54:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESNew Information
Oct-16-2020 12:15:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943154
Page 189 of 208
***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: 11521476 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
Nov-13-2020 03:36:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Nov-12-2020 14:35:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Changed Information
Nov-12-2020 14:35:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020Changed Information
Nov-12-2020 09:24:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opened EOT
DISCONTINUATION
DATE must be relative
to AE that caused
withdrawal of study
vaccine & since AE
start=14OCT2020 &
end=23OCT2020, EOT
DISCONTINUATION
DATE must be within
that time period. Please
refer to source related
to AE then adjust date
accordingly
Nov-12-2020 09:17:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Will re-write a clearer
query.
Nov-11-2020 06:28:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered I would be happy to
comply if I could.
Nov-10-2020 23:56:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-10-2020 19:54:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened The discontinuation
date of 25SEP2020
should be relative to the
AE causing the the
withdrawal of the study
vaccine, AE start
14OCT2020 and end
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943155
Page 190 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
23OCT2020 (date
should not be after the
AE ended). Please
adjust Discontinuation
date.
Nov-10-2020 17:43:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Well, I can't change this
anyway.
Nov-10-2020 15:37:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Since Subject
discontinued from
treatment due to
Adverse Event, the date
of discontinuation
should be between start
date and prior to stop
date of Adverse Event
causing the
discontinuation. Please
update accordingly.
Oct-29-2020 07:54:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-29-2020 07:54:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-12-2020 08:41:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-11-2020 06:30:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered I was told to do this
for another subject and
than was told the FUP
form is only
completed if the
subject discontinues
the STUDY. I will not
go round and round
with this again. I
believe this query is
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943156
Page 191 of 208
***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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
INCORRECT. Please
review.
Nov-10-2020 22:24:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Please confirm if
subject treatment is
discontinued early due
to AE. If yes, kindly
updated FUP
disposition CRF
accordingly. Or
clarify.
Nov-10-2020 17:41:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Subject did NOT
discontinue the study.
Only discontinued
receiving second
vaccine.
Nov-10-2020 15:40:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened Since Subject
discontinued from
study per adverse
event, the FUP page
needs to be completed
with the same
information then the
End of Treatment page
(discontinuation date
should be between
start date and prior to
stop date of AE).
Thank You!
Oct-29-2020 07:54:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-29-2020 07:54:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check
and correct the data.
Oct-29-2020 07:54:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943157
Page 192 of 208
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021 09:48:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/23/2021Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943158
Page 193 of 208
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-23-2021 09:48:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/23/2021Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943159
Page 194 of 208
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-23-2021 09:48:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-23-2021 09:48:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-23-2021 20:16:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-23-2021 09:48:39
(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.
Feb-23-2021 09:48:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/23/2021Initial Entry
5.a
Date Location User Value Reason
Feb-23-2021 20:16:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRCMZZInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-23-2021 20:16:51 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943160
Page 195 of 208
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific Time
(US & Canada)BRCMZZ
5.b
Date Location User Value Reason
Feb-23-2021 20:17:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRCN00Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-23-2021 20:17:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BRCN00Initial Entry
5.c
Date Location User Value Reason
Feb-23-2021 20:17:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS6KWGInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-23-2021 20:17:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BS6KWGInitial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943161
Page 196 of 208
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 11521476 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-23-2021 09:49:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-23-2021 09:49:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-23-2021 20:17:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-23-2021 09:49:00
(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.
Feb-23-2021 09:49:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/23/2021Initial Entry
5.a
Date Location User Value Reason
Feb-23-2021 20:17:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRMT3MInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-23-2021 20:17:34 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fcd\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943162
Page 197 of 208
***Confidential***
Header Text: c4591001
Visit: V201_S
…[truncated]