Document text
Page 1 of 186
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922722
Page 2 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/19/2020
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922723
Page 3 of 186
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10921015]
2.Birth Date: 1952
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922724
Page 4 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922725
Page 5 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922726
Page 6 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922727
Page 7 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myopia]
Start Date: Jun/UNK/1962
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tonsillitis]
Start Date: Jun/UNK/1962
Ongoing: NO
End Date:
UNK/UNK/1962
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[basal cell carcinoma right shoulder]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[basal cell carcinoma on nose]
Start Date: Aug/UNK/2018
Ongoing: NO
End Date:
Aug/UNK/2018
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922728
Page 8 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[basal cell carcinoma on nose]
Start Date: Jun/UNK/2020
Ongoing: NO
End Date:
UNK/UNK/2020
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[actinic keratosis]
Start Date: Jun/UNK/2013
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: Jun/UNK/1988
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[dyslipidemia]
Start Date: Jun/UNK/1988
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gastro esophageal reflux disease]
Start Date: Jun/UNK/2019
Ongoing: YES
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922729
Page 9 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[umbilical hernia]
Start Date: UNK/UNK/1955
Ongoing: NO
End Date:
UNK/UNK/1955
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[inguinal hernia]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendicitis]
Start Date: Jun/UNK/1968
Ongoing: NO
End Date:
UNK/UNK/1968
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[plantar fasciitis in the right foot]
Start Date: Jun/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922730
Page 10 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergies]
Start Date: UNK/UNK/1952
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[environmental allergies]
Start Date: UNK/UNK/1952
Ongoing: YES
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922731
Page 11 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
2.Weight: [188.8]
3.Unit: LB
4.Height: [67.7]
5.Unit: in
6.Body Mass Index: [29.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922732
Page 12 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/19/2020
2.Randomization Number: [233770]
3.Randomization Group: [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922733
Page 13 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5WL8]
5.bSample ID [BN5WL9]
5.cSample ID [BN5WLB]
5.dSample ID [BL9TNF]
5.eSample ID [BL9TNG]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922734
Page 14 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5WKS]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922735
Page 15 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/19/2020 15:54
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
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922736
Page 16 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922737
Page 17 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922738
Page 18 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Oct/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922739
Page 19 of 186
***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, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/6/2020Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[There was a delay in vaccine for this subject sample BN5X6N will be
destroyed]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5X6N] Comments
5.bSample ID [BM9L1K] Comments
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922740
Page 20 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Sep/9/2020
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESSComments
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/6/2020 14:30 Comments
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT Comments
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 Comments
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922741
Page 21 of 186
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922742
Page 22 of 186
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/2/2020
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 [BSJR5Y]
5.bSample ID [BM9L7Y]
5.cSample ID [BSJR5M]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922743
Page 23 of 186
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922744
Page 24 of 186
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/3/2021
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 [BSM62Y]
5.bSample ID [BRBT3N]
5.cSample ID [BSM62N]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922745
Page 25 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922746
Page 26 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922747
Page 27 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922748
Page 28 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922749
Page 29 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922750
Page 30 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922751
Page 31 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922752
Page 32 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922753
Page 33 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922754
Page 34 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922755
Page 35 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922756
Page 36 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922757
Page 37 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922758
Page 38 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922759
Page 39 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Oct/6/2020
Contact Outcome:
VISIT ARRANGED
3.Comments: [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922760
Page 40 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Oct/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922761
Page 41 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Not Applicable
//Comments
2.Injection Site Location
3.Injection Site Body Side: LEFT
Reaction
4.aReaction: REDNESS
Reaction Present: NO
4.bReaction: SWELLING
Reaction Present: NO
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: NO
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: NO
5.cSymptom: HEADACHE
Symptom Present: NO
5.dSymptom: VOMITING
Symptom Present: NO
5.eSymptom: DIARRHEA
Symptom Present: NO
5 fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: NO
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: NO
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922762
Page 42 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.hSymptom: CHILLS
Symptom Present: NO
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922763
Page 43 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922764
Page 44 of 186
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922765
Page 45 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922766
Page 46 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922767
Page 47 of 186
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Arrhythmia atrial fibril
lation Aug/26/2020 UNK:
UNK NO
End Date Time:
Aug/27/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Elevated troponin Aug/26/2020 UNK:
UNK NO
End Date Time:
Aug/26/2020 UNK:UNK
Repeating
Pages
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922768
Page 48 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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)[Arrhythmia atrial fibrillation]
4.Start Date Time: Aug/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/27/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[medical records being reviewed not able to answer at this time.]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922769
Page 49 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020350164]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922770
Page 50 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Elevated troponin]
4.Start Date Time: Aug/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/26/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922771
Page 51 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922772
Page 52 of 186
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922773
Page 53 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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[ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922774
Page 54 of 186
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922775
Page 55 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: //
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922776
Page 56 of 186
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922777
Page 57 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922778
Page 58 of 186
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922779
Page 59 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922780
Page 60 of 186
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922781
Page 61 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922782
Page 62 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922783
Page 63 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922784
Page 64 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922785
Page 65 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922786
Page 66 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922787
Page 67 of 186
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922788
Page 68 of 186
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922789
Page 69 of 186
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922790
Page 70 of 186
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922791
Page 71 of 186
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922792
Page 72 of 186
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922793
Page 73 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922794
Page 74 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922795
Page 75 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922796
Page 76 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/2/2020
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922797
Page 77 of 186
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922798
Page 78 of 186
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-10-2021 11:28:50 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922799
Page 79 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormAug-19-2020 16:05:12 (UTC-05:00) Eastern Time
(US & Canada)All inclusion and exclusion criteria met.
Not Applicable
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922800
Page 80 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Jan-25-2021 15:31:26 (UTC-05:00) Eastern Time
(US & Canada)BN5X6N nasal swab was taken on the day vaccine
was delayed,9/sep/2020. The correct swab that
needed to be entered and sent to lab was collected
on 6/oct/2020 BM9L1K. Per EDC guidelines both
barcode are entered using the date of vaccine please
advise
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922801
Page 81 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.aJan-25-2021 15:31:42 (UTC-05:00) Eastern Time
(US & Canada)BN5X6N nasal swab was taken on the day vaccine
was delayed,9/sep/2020. The correct swab that
needed to be entered and sent to lab was collected
on 6/oct/2020 BM9L1K. Per EDC guidelines both
barcode are entered using the date of vaccine please
advise
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922802
Page 82 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.bNov-07-2020 16:06:44 (UTC-05:00) Eastern Time
(US & Canada)Sample BM9L1K Collected at delayed Vaccination
Visit 06Oct2020
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922803
Page 83 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormNov-05-2020 06:59:25 (UTC-05:00) Eastern Time
(US & Canada)Please allow for sections 2 through 4 to be erased
so data can be entered
FormSep-23-2020 09:56:44 (UTC-05:00) Eastern Time
(US & Canada)vaccination not done
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922804
Page 84 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Sep-22-2020 09:16:56 (UTC-05:00) Eastern Time
(US & Canada)vaccine not given on this date due to illness
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922805
Page 85 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Nov-06-2020 13:33:16 (UTC-05:00) Eastern Time
(US & Canada)
4Sep-23-2020 08:36:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922806
Page 86 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Nov-06-2020 13:33:28 (UTC-05:00) Eastern Time
(US & Canada)
6Sep-23-2020 08:36:58 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922807
Page 87 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
11Nov-06-2020 13:33:38 (UTC-05:00) Eastern Time
(US & Canada)
11Sep-23-2020 08:37:12 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922808
Page 88 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Oct-07-2020 14:56:18 (UTC-05:00) Eastern Time
(US & Canada)No reaction visit, was a delayed vaccine 2, no
reactions on site day of vaccine 2
Not Applicable
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922809
Page 89 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormJan-22-2021 09:31:27 (UTC-05:00) Eastern Time
(US & Canada)Kofi Amoah Not Applicable
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922810
Page 90 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Jan-22-2021 09:31:27 (UTC-05:00) Eastern Time
(US & Canada)Kofi Amoah Not Applicable
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922811
Page 91 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormJan-22-2021 09:31:41 (UTC-05:00) Eastern Time
(US & Canada)Kofi Amoah Not Applicable
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922812
Page 92 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Jan-22-2021 09:31:41 (UTC-05:00) Eastern Time
(US & Canada)Kofi Amoah Not Applicable
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922813
Page 93 of 186
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-10-2021 11:28:50 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-03-2021 14:16:33 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-24-2021 10:06:35 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-25-2021 15:11:52 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-22-2021 13:21:25 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922814
Page 94 of 186
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-14-2020 09:22:51 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-16-2020 14:56:06 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-16-2020 09:10:39 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-10-2020 11:28:04 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922815
Page 95 of 186
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
N/A Nov-02-2020 14:17:29 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-22-2020 11:34:04 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922816
Page 96 of 186
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-19-2020 16:03:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-19-2020 16:03:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922817
Page 97 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-19-2020 16:04:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/19/2020Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922818
Page 98 of 186
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-14-2020 05:50:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Recorded as AE Atrial
fibrillation
Sep-11-2020 07:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per query
Sep-11-2020 05:16:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020350164
NO ADVERSE
EFFECT(onset
date:26Aug2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
if subject experienced an
SAE.If yes, please update
the term in Safety Db and
add event in AE CRF
Aug-19-2020 16:03:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10921015Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-19-2020 16:03:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1952Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-19-2020 16:04:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922819
Page 99 of 186
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-19-2020 16:04:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-19-2020 16:04:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922820
Page 100 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-19-2020 16:04:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922821
Page 101 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-19-2020 16:05:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-19-2020 16:05:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-19-2020 16:05:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922822
Page 102 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Aug-19-2020 17:46:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Myopia
Start Date: Jun/UNK/196
2
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-19-2020 17:46:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 17:46:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MyopiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-19-2020 17:46:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/1962Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-19-2020 17:46:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922823
Page 103 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-19-2020 17:46:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:tonsillitis
Start Date: Jun/UNK/1962
Ongoing: NO
End Date:
UNK/UNK/1
962Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-19-2020 17:46:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 17:46:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
tonsillitisInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-19-2020 17:46:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/1962Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-19-2020 17:46:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1962Initial Entry
1.c
Date Location User Value Reason
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922824
Page 104 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-19-2020 17:48:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:basal cell carcinoma r
ight shoulder
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012Initial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-19-2020 17:48:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 17:48:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
basal cell carcinoma right shoulderInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-19-2020 17:48:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-19-2020 17:48:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
1.d
Date Location User Value Reason
Aug-19-2020 17:49:02 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922825
Page 105 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern Time
(US & Canada)(autocalc) Line/MH Num
ber:4
Medical Histor
y Term:basal cell carcinom
a on nose
Start Date: Aug/UNK/2018
Ongoing: NO
End Date:
Aug/UNK/2018
1.d Line/MH Number:
Date Location User Value Reason
Aug-19-2020 17:49:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 17:49:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
basal cell carcinoma on noseInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-19-2020 17:49:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-19-2020 17:49:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/UNK/2018Initial Entry
1.e
Date Location User Value Reason
Aug-19-2020 17:49:46
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num 5Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922826
Page 106 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada) ber:
Medical Histor
y Term:basal cell carcinom
a on nose
Start Date: Jun/UNK/2020
Ongoing: NO
End Date:
UNK/UNK/2020
1.e Line/MH Number:
Date Location User Value Reason
Aug-19-2020 17:49:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 17:49:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
basal cell carcinoma on noseInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-19-2020 17:49:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-19-2020 17:49:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2020Initial Entry
1.f
Date Location User Value Reason
Aug-19-2020 17:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922827
Page 107 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Medical History Ter
m:actinic keratos
is
Start Date: Jun/UNK/201
3
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Aug-19-2020 17:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 17:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
actinic keratosisInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-19-2020 17:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2013Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-19-2020 17:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-19-2020 17:51:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Ter
m:hypertension
Start Date: Jun/UNK/198
8
Ongoing: YESInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922828
Page 108 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.g Line/MH Number:
Date Location User Value Reason
Aug-19-2020 17:51:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 17:51:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hypertensionInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-19-2020 17:51:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/1988Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-19-2020 17:51:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-19-2020 17:52:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Ter
m:dyslipidemia
Start Date: Jun/UNK/198
8
Ongoing: YESInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922829
Page 109 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.h Line/MH Number:
Date Location User Value Reason
Aug-19-2020 17:52:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 17:52:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
dyslipidemiaInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-19-2020 17:52:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/1988Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-19-2020 17:52:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-19-2020 17:52:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9
Medical Histor
y Term:gastro esophageal re
flux disease
Start Date: Jun/UNK/2019
Ongoing: YESInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922830
Page 110 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.i Line/MH Number:
Date Location User Value Reason
Aug-19-2020 17:52:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 17:52:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
gastro esophageal reflux diseaseInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-19-2020 17:52:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2019Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-19-2020 17:52:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-19-2020 17:54:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:10
Medical History T
erm:umbilical hernia
Start Date: UNK/UNK/195
5
Ongoing: NO
End Date:
UNK/UNK/1
955Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922831
Page 111 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.j Line/MH Number:
Date Location User Value Reason
Aug-19-2020 17:54:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 17:54:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
umbilical herniaInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-19-2020 17:54:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1955Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-19-2020 17:54:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1955Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922832
Page 112 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.k
Date Location User Value Reason
Aug-19-2020 18:00:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:11
Medical History T
erm:inguinal hernia
Start Date: UNK/UNK/201
1
Ongoing: NO
End Date:
UNK/UNK/2
011Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922833
Page 113 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.k Line/MH Number:
Date Location User Value Reason
Aug-19-2020 18:00:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 18:00:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inguinal herniaInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-19-2020 18:00:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-19-2020 18:00:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
1.l
Date Location User Value Reason
Aug-19-2020 18:01:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:12
Medical History T
erm:appendicitis
Start Date: Jun/UNK/1968
Ongoing: NO
End Date:
UNK/UNK/1
968Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922834
Page 114 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.l Line/MH Number:
Date Location User Value Reason
Aug-19-2020 18:01:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 18:01:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
appendicitisInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-19-2020 18:01:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/1968Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-19-2020 18:01:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1968Initial Entry
1.m
Date Location User Value Reason
Aug-24-2020 08:38:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:13
Medical Hist
ory Term:plantar fasciitis in t
he right foot
Start Date: Jun/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/201
8Changed
Information
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922835
Page 115 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-21-2020 10:17:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:13
Medical Histo
ry Term:plantar fascia in th
e right foot
Start Date: Jun/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/201
8Changed
Information
Aug-20-2020 08:06:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:13
Medical Histor
y Term:plantar fascia rig
ht foot
Start Date: Jun/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2
018Changed
Information
Aug-19-2020 18:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:13
Medical History
Term:plantar fascia
Start Date: Jun/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/
2018Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922836
Page 116 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.m Line/MH Number:
Date Location User Value Reason
Aug-19-2020 18:03:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
09:45:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 3: Closed Discrepancy has
been closed.
Aug-24-2020
08:38:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answer
edChanged
Information
Aug-24-2020
08:38:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
plantar fasciitis in
the right footChanged
Information
Aug-22-2020
23:27:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 3: Opened Clarify
PLANTAR
FASCIA IN THE
RIGHT FOOT as
follows...Term is
unclear. Are you
reporting
PLANTAR
FASCIITIS IN
THE RIGHT
FOOT? If so,
update the
verbatim term as
such. Otherwise
clarify and
update the term
as appropriate.
Thank you.
Aug-22-2020
18:23:45ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 2: Closed Discrepancy has
been closed.
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922837
Page 117 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)
Aug-21-2020
10:17:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answer
edChanged
Information
Aug-21-2020
10:17:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
plantar fascia in t
he right footChanged
Information
Aug-21-2020
00:01:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 2: Opened Clarify
PLANTAR
FASCIA RIGHT
FOOT as
follows...Body
site only
reported. Specify
the
corresponding
symptom,
diagnosis or
procedure being
reported and
update the
verbatim term
accordingly.
Thank you.
Aug-20-2020
17:50:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Aug-20-2020
08:06:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answer
edChanged
Information
Aug-20-2020
08:06:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
plantar fascia rig
ht footChanged
Information
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922838
Page 118 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-20-2020
03:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Opened Clarify
PLANTAR
FASCIA as
follows...Site
only reported.
Specify the
corresponding
symptom,
diagnosis or
procedure being
reported and edit
the term. Thank
you.
Aug-19-2020
18:03:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
plantar fasciaInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-19-2020 18:03:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2017Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-19-2020 18:03:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.n
Date Location User Value Reason
Aug-19-2020 18:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 14
Medical History Te
rm:seasonal allerg
ies
Start Date: UNK/UNK/19
52
Ongoing: YESInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922839
Page 119 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.n Line/MH Number:
Date Location User Value Reason
Aug-19-2020 18:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 18:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
seasonal allergiesInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-19-2020 18:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1952Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-19-2020 18:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Aug-19-2020 18:04:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:15
Medical History
Term:environmental all
ergies
Start Date: UNK/UNK/1952
Ongoing: YESInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922840
Page 120 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.o Line/MH Number:
Date Location User Value Reason
Aug-19-2020 18:04:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 18:04:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
environmental allergiesInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-19-2020 18:04:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1952Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-19-2020 18:04:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922841
Page 121 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Aug-19-2020 18:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-19-2020 18:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
188.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-19-2020 18:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-19-2020 18:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
67.7Initial Entry
5. Unit:
Date Location User Value Reason
Aug-19-2020 18:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-19-2020 18:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.0Initial Entry
7.a
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922842
Page 122 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Aug-19-2020 18:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.0
Temperature Unit: F
Temperature Locatio
n::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-19-2020 18:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-19-2020 18:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-19-2020 18:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-19-2020 18:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922843
Page 123 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-19-2020 18:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-19-2020 18:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
233770Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922844
Page 124 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 16:06:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 16:06:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020 16:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020 16:06:47
(UTC-05:00) Eastern 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.
Aug-19-2020 16:06:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020 16:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5WL8Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922845
Page 125 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-19-2020 16:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN5WL8Initial Entry
5.b
Date Location User Value Reason
Aug-19-2020 16:07:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5WL9Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-19-2020 16:07:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN5WL9Initial Entry
5.c
Date Location User Value Reason
Aug-19-2020 16:07:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5WLBInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-19-2020 16:07:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN5WLBInitial Entry
5.d
Date Location User Value Reason
Aug-19-2020 16:08:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9TNFInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922846
Page 126 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.d Sample ID
Date Location User Value Reason
Aug-19-2020 16:08:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BL9TNFInitial Entry
5.e
Date Location User Value Reason
Aug-19-2020 16:08:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9TNGInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-19-2020 16:08:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BL9TNGInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922847
Page 127 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 16:06:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 16:06:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020 16:06:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020 16:06:23
(UTC-05:00) Eastern 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.
Aug-19-2020 16:06:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020 16:06:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5WKSInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0922848
Page 128 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-19-2020 16:06:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN5WKSInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922849
Page 129 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-19-2020 18:07:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-19-2020 18:07:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-19-2020 18:07:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-19-2020 18:07:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020 15:54Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-19-2020 18:07:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-19-2020 18:07:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922850
Page 130 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Aug-19-2020 18:07:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-19-2020 18:07:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-19-2020 18:07:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922851
Page 131 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-19-2020 16:05:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922852
Page 132 of 186
***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, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-25-2021 17:18:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Changed Information
Sep-09-2020 16:06:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922853
Page 133 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Jan-25-2021 17:19:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Changed Information
Nov-06-2020 14:57:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-06-2020 13:34:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Vital Signs Date is
not same as
Vaccination Date in
the same visit. Please
review and update as
appropriate or
clarify.
Sep-11-2020 07:28:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2.a
Date Location User Value Reason
Sep-11-2020 07:28:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.5
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-11-2020 07:28:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-11-2020 07:28:40 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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) (6)
FDA-CBER-2021-5683-0922854
Page 134 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern Time
(US & Canada)98.5
2.a Unit:
Date Location User Value Reason
Sep-11-2020 07:28:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-11-2020 07:28:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922855
Page 135 of 186
***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, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020 16:06:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020 16:06:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-26-2021 11:33:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 8: Closed Response satisfies
query
Jan-26-2021 11:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 9: Closed Close per site
response
Jan-25-2021 15:32:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 9: Answered BN5X6N nasal swab
was taken on the day
vaccine was
delayed,9/sep/2020.
The correct swab that
needed to be entered
and sent to lab was
collected on
6/oct/2020 BM9L1K.
Per EDC guidelines
both barcode are
entered using the date
of vaccine please
advise
Jan-25-2021 15:32:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 8: Answered BN5X6N nasal swab
was taken on the day
vaccine was
delayed,9/sep/2020.
The correct swab that
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922856
Page 136 of 186
***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, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
needed to be entered
and sent to lab was
collected on
6/oct/2020 BM9L1K.
Per EDC guidelines
both barcode are
entered using the date
of vaccine please
advise
Jan-25-2021 15:22:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 9: Opened Date of Collection
06/Oct/2020 is
greater than Date of
Visit 09/Sep/2020.
Please review and
update as
appropriate, else
clarify.
Jan-25-2021 15:22:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/6/2020Changed Information
Jan-25-2021 15:11:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 8: Opened There are more than
1 barcode present for
sample collection.
Please review and
correct as
appropriate.
Dec-15-2020 09:18:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 6: Closed Response satisfies
query
Dec-14-2020 09:25:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 6: Answered BN5X6N is the
barcode for
10921015 for visit 2
09/SEP/2020 on the
SCF at our site.
Dec-14-2020 09:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 7: Deleted Close Auto Query
Dec-14-2020 09:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 7: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922857
Page 137 of 186
***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, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
correct as
appropriate.
Dec-11-2020 10:54:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 6: Opened LIMS: Nasal swab
BM9L1K was
received by the lab
for Visit2. Please
consider re-entering
all barcodes in
inform including
destroyed barcodes.
Please review and
update or submit
updated SCF.
Nov-08-2020 08:24:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 5: Closed Response satisfies
query
Nov-08-2020 01:43:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Nov-07-2020 16:08:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 5: Answered Added Barcode taken
at Delayed
Vaccination Visit
Nov-07-2020 16:08:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered Added barcode taken
at Delayed
Vaccination Visit
Nov-07-2020 16:05:51
(UTC-05:00) Eastern
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-07-2020 14:01:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened HOLDS: Nasal swab
BM9L1K was
received by the lab
for Visit2. Please
consider entering all
barcodes in inform
including destroyed
barcodes. Please
review and update or
submit updated SCF.
Nov-07-2020 14:01:33 ACV0PFEINFP6000 Query 3: Closed re-queried
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922858
Page 138 of 186
***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, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)
Nov-07-2020 13:57:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened HOLDS: Nasal swab
BM9L1K was
received by the lab
for COVID_A.
Please consider
entering all barcodes
in inform including
destroyed barcodes.
Please review and
update or submit
updated SCF.
Nov-06-2020 15:01:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-06-2020 13:34:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Date of Collection is
more than 1 day
before Dose Date on
the Vaccination form.
Please review and
update as
appropriate, else
clarify.
Sep-09-2020 16:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-09-2020 16:06:34
(UTC-05:00) Eastern
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-09-2020 16:06:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-25-2021 17:26:01 ACV0PFEINFP6000 auto query Query 1: Closed Close Auto Query
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0922859
Page 139 of 186
***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, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern Time
(US & Canada)(autoquery)
Jan-25-2021 17:26:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
There was a delay in vaccine for this
subject sample BN5X6N will be dest
royedTranscription Error
Jan-25-2021 17:24:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Entered text has
either a carriage
return (line break) or
extra spaces at the
end of the text or
between words.
Please correct by
removing all data in
the field and re-enter
without adding extra
spaces or using enter
or tab keys.
Jan-25-2021 17:24:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
There was a vaccine delay sample ba
rcode BN5X6N will be destroyedInitial Entry
5.a
Date Location User Value Reason
Dec-14-2020 09:23:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5X6NChanged Information
Dec-14-2020 09:22:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID:Transcription Error
Sep-09-2020 16:06:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5X6NInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-14-2020 09:23:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN5X6NChanged Information
Dec-14-2020 09:22:51
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry: Transcription Error
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0922860
Page 140 of 186
***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, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
Sep-09-2020 16:06:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN5X6NInitial Entry
5.b
Date Location User Value Reason
Jan-25-2021 15:11:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM9L1KChanged Information
Nov-16-2020 09:10:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM9L1KTranscription Error
(DELETED)
Nov-07-2020 16:05:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM9L1KInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-25-2021 15:11:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM9L1KChanged Information
Nov-16-2020 09:10:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM9L1KTranscription Error
(DELETED)
Nov-07-2020 16:05:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM9L1KInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922861
Page 141 of 186
***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, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 08:33:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of First Delay:
Sep/9/2020
Reason(s) for Temporary Delay of
Vaccination
FEVER OR ACUTE ILLNESSInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-06-2020 13:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-06-2020 13:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Nov-07-2020
10:50:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
4: Clo
sedResponse satisfies query
Nov-07-2020
09:26:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
4: Ans
weredPlease allow EOT visit to
be updated
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922862
Page 142 of 186
***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, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-06-2020
21:58:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
4: Op
enedDMW5308058;Date is after
‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Treatment eCRF. Please
clarify or correct.
Nov-06-2020
16:39:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedResponse satisfies query
Nov-06-2020
15:01:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Clo
sedResponse satisfies query
Nov-06-2020
13:35:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Ans
weredon 09Sep2020 dose was
delayed. Dose given
06Oct2020
Nov-06-2020
13:34:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
3: Op
enedDose Date is not equal to
Date of Visit 09/Sep/2020
of the corresponding Visit.
Please review and update as
appropriate.
Nov-06-2020
13:34:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Oct/6/
2020
14:30Initial Entry
Nov-06-2020
13:33:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:Initial Entry
Nov-05-2020
06:59:58ACV0PFEINFP6000 Query
2: AnsPlease allow for sections 2
through 4 to be erased so
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922863
Page 143 of 186
***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, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time
(US &
Canada)wereddata can be entered
Nov-05-2020
00:27:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Balaji Prabu R Query
2: Rei
ssued:
Opene
dPlease do not remove
temporary delay details and
should stat as is. But, please
remove the item comments
and add vaccine details.
Nov-04-2020
10:40:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredvaccine given 10/6/20 this
page is actually locked. do
you want new date put here
and delay taken away now
that vaccine has been given
Nov-04-2020
07:24:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Balaji Prabu R Query
2: Op
enedPlease confirm whether this
subject received vaccination
2 in October based on
previous response. If
received after temporary
delay, complete this CRF.
Else clarify.
Sep-27-2020
02:59:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Sep-25-2020
09:29:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredVax 2 not given due to SAE
event, dose was delayed and
subject will be dosed for
Vax 2 in october
Sep-25-2020
06:03:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Op
enedDMW4795103;Dose Date
is not expected to be
Unknown or Not
Applicable. Please review
and update appropriately or
clarify
Sep-24-2020
01:43:00
(UTC-05:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Can
didateDMW4795103;Dose Date
is not expected to be
Unknown or Not
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922864
Page 144 of 186
***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, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time
(US &
Canada)Applicable. Please review
and update appropriately or
clarify
Sep-23-2020
08:36:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-06-2020 13:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-06-2020 13:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
Nov-06-2020 13:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-23-2020 08:36:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
7. Route:
Date Location User Value Reason
Nov-06-2020 13:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-06-2020 13:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922865
Page 145 of 186
***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, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Nov-06-2020 13:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
Nov-06-2020 13:33:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-23-2020 08:37:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922866
Page 146 of 186
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-07-2020 10:51:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Nov-07-2020 09:27:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Please allow for
EOT visit to be
updated
Nov-07-2020 03:35:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened PDQ: DOV at this
visit is out of
window (-1 day)
from DOV (9/Sep
/2020) at V2. Please
reconcile and update
accordingly, else
confirm date is
correct as is.
Nov-04-2020 01:17:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed As per site
confirmation -
updated PD tracker
Nov-03-2020 09:37:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Date correct
Nov-03-2020 06:37:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened PDQ: DOV at this
visit is out of
window (19 day)
from DOV (9/Sep
/2020) at
V2_VAX2_L. Please
reconcile and update
accordingly, else
confirm date is
correct as is.
Nov-02-2020 14:17:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Initial Entry
Nov-02-2020 14:17:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/2/2020Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922867
Page 147 of 186
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-27-2020 09:08:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Candidate As per CRF
guidelines, the
treatment period is
defined as 1st
vaccination visit
through the 1-month
post vaccination visit
after the 2nd
vaccination. Hence,
please complete
treatment disposition
CRF and update date
of EOT to match the
date the Visit 3.
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922868
Page 148 of 186
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-02-2020 14:17:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-02-2020 14:17:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020 14:18:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-02-2020 14:17:44
(UTC-05:00) Eastern 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.
Nov-02-2020 14:17:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/2/2020Initial Entry
5.a
Date Location User Value Reason
Nov-02-2020 14:18:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSJR5YInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922869
Page 149 of 186
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-02-2020 14:18:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BSJR5YInitial Entry
5.b
Date Location User Value Reason
Nov-02-2020 14:18:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM9L7YInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-02-2020 14:18:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM9L7YInitial Entry
5.c
Date Location User Value Reason
Nov-02-2020 14:18:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSJR5MInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-02-2020 14:18:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BSJR5MInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922870
Page 150 of 186
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-03-2021 14:16:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/3/2021Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922871
Page 151 of 186
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-03-2021 14:21:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-03-2021 14:21:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-03-2021 14:22:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-03-2021 14:21:45
(UTC-05:00) Eastern 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.
Mar-03-2021 14:21:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/3/2021Initial Entry
5.a
Date Location User Value Reason
Mar-03-2021 14:22:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSM62YInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922872
Page 152 of 186
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Mar-03-2021 14:22:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BSM62YInitial Entry
5.b
Date Location User Value Reason
Mar-03-2021 14:22:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRBT3NInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-03-2021 14:22:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BRBT3NInitial Entry
5.c
Date Location User Value Reason
Mar-03-2021 14:22:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSM62NInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-03-2021 14:22:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BSM62NInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922873
Page 153 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020 14:54:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922874
Page 154 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Assessments
Date Location User Value Reason
Oct-07-2020 14:54:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-07-2020 14:54:21
(UTC-05:00) Eastern 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.
Oct-07-2020 14:54:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922875
Page 155 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Contact Type:
Date Location User Value Reason
Oct-07-2020 14:54:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Oct-08-2020 07:23:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Deleted forms are updated
Oct-07-2020 14:54:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 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.
Oct-07-2020 14:54:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Oct/6/2020
Contact Outcome:
VISIT ARRANGEDInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922876
Page 156 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Oct-07-2020 14:55:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
2.a
Date Location User Value Reason
Oct-07-2020 14:55:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.2
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-07-2020 14:55:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-07-2020 14:55:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-07-2020 14:55:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922877
Page 157 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-07-2020 14:55:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922878
Page 158 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Injection Site Body Side:
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
4.a
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Reaction:: REDNESS
Reaction Present:: NOInitial Entry
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Reaction:: REDNESS
Reaction Present::Initial Entry
4.a Reaction:
Date Location User Value Reason
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
4.a Reaction Present:
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922879
Page 159 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Reaction:: SWELLING
Reaction Present:: NOInitial Entry
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Reaction:: SWELLING
Reaction Present::Initial Entry
4.b Reaction:
Date Location User Value Reason
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
4.b Reaction Present:
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: PAIN AT INJECTIO
N SITE
Symptom Pre
sent::NOInitial Entry
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: PAIN AT INJECTIO
N SITE
Symptom Pre
sent::Initial Entry
5.a Symptom:
Date Location User Value Reason
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922880
Page 160 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.a Symptom Present:
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FATIGUE/TIRED
NESS
Symptom Prese
nt::NOInitial Entry
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FATIGUE/TIRED
NESS
Symptom Prese
nt::Initial Entry
5.b Symptom:
Date Location User Value Reason
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUE/TIREDNESSInitial Entry
5.b Symptom Present:
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEADACHE
Symptom Present:: NOInitial Entry
Oct-07-2020 14:56:18 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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), (b) (6)
FDA-CBER-2021-5683-0922881
Page 161 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern Time
(US & Canada)Symptom:: HEADACHE
Symptom Present::
5.c Symptom:
Date Location User Value Reason
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
5.c Symptom Present:
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.d
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VOMITING
Symptom Present:: NOInitial Entry
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VOMITING
Symptom Present::Initial Entry
5.d Symptom:
Date Location User Value Reason
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
5.d Symptom Present:
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.e
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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), (b) (6)
FDA-CBER-2021-5683-0922882
Page 162 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIARRHEA
Symptom Present:: NOInitial Entry
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIARRHEA
Symptom Present::Initial Entry
5.e Symptom:
Date Location User Value Reason
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
5.e Symptom Present:
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.f
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR WORSENE
D MUSCLE PAIN
Symptom
Present::NOInitial Entry
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR WORSENE
D MUSCLE PAIN
Symptom
Present::Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922883
Page 163 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.f Symptom:
Date Location User Value Reason
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
5.f Symptom Present:
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.g
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR WORSENE
D JOINT PAIN
Symptom P
resent::NOInitial Entry
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR WORSENE
D JOINT PAIN
Symptom P
resent::Initial Entry
5.g Symptom:
Date Location User Value Reason
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
5.g Symptom Present:
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.h
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922884
Page 164 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/06/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CHILLS
Symptom Present:: NOInitial Entry
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CHILLS
Symptom Present::Initial Entry
5.h Symptom:
Date Location User Value Reason
Oct-07-2020 14:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
5.h Symptom Present:
Date Location User Value Reason
Oct-07-2020 14:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922885
Page 165 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-08-2020 00:37:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-07-2020 16:09:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Nov-07-2020 16:09:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/2/2020Changed Information
Nov-07-2020 11:06:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: EOT form is
now unfrozen. Please
review and update as
appropriate.
Nov-07-2020 09:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Please allow for data
to be updated
Nov-07-2020 07:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 1: Opened As per CRF
guidelines, the
treatment period is
defined as 1st
vaccination visit
through the 1-month
post vaccination visit
after the 2nd
vaccination. Please
complete treatment
disposition CRF and
update date of EOT
to match the date the
Visit 3 blood draw
Oct-16-2020 10:34:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922886
Page 166 of 186
***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: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-16-2020 10:34:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-27-2020 09:09:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Query issued on V3.
Oct-26-2020 08:28:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered V3 not completed yet
Oct-26-2020 06:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 1: Opened As per CRF
guidelines, the
treatment period is
defined as 1st
vaccination visit
through the 1-month
post vaccination visit
after the 2nd
vaccination. Please
update status or
update date of EOT
to match the date the
Visit 3, if visit 3
completed.
Oct-16-2020 10:34:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0922887
Page 167 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Sep-11-2020 07:42:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0922888
Page 168 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Sep-29-2020 14:27:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0922889
Page 169 of 186
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Sep-11-2020 07:42:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-11-2020 07:42:22
(UTC-05:00) Eastern 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
Nov-03-2020
00:47:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Clos
edQuery closed; will
follow for SAE update
with the requested
COVID test info
Nov-02-2020
17:03:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Ans
weredFollow-Up SAE being
submitted
Oct-28-2020
00:57:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Reis
sued:OpenedClinical – Thank you.
If NO hospital Covid
test was performed is
known, please submit
this information on a
follow-up SAE form,
as pertinent
information for this
trial.
Oct-27-2020
08:37:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Ans
weredPlease see SAE
Follow-up report page
11 of 12. SAE not
related, test not done.
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922890
Page 170 of 186
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-26-2020
15:49:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Reis
sued:OpenedPlease report the
COVID test result and
date performed on a
follow-up SAE form
[lab test section;
#2020350164] as a
pertinent negative test
result for this trial.
Oct-23-2020
08:41:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Ans
weredTest not performed
Oct-21-2020
11:07:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Ope
nedCLINICAL COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020350164] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the results.
Sep-30-2020
13:59:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Clos
edResponse satisfies
query
Sep-29-2020
14:26:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Ans
weredChanged data per
query
Sep-29-2020
09:32:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Ope
nedCLINQUERY: On
review of the SAE
report for Atrial
fibrillation, an event
of elevated troponin
has been mentioned,
yet it does not appear
in the CRF. Please
review for safety and
update AE log CRF
accordingly.
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922891
Page 171 of 186
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-15-2020
07:32:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Clos
edacceptable
discrepancy
Sep-14-2020
08:33:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Clos
edDiscrepancy has been
closed.
Sep-14-2020
07:40:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Ans
weredTranscription Error
Sep-14-2020
07:40:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredTranscription Error
Sep-14-2020
07:40:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Arrhythmia at
rial fibrillationTranscription Error
Sep-14-2020
05:46:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Ope
nedSAE RECON:
AER#2020350164,the
term was updated in
Safety database to
Atrial fibrillation.
Please confirm correct
term. If safety update
is required, please
submit a follow-up
form.
Sep-11-2020
21:40:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Ope
nedSpacing: Verbatim
Term contains leading,
trailing or more than
one consecutive space.
Sep-11-2020
07:42:22
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Data Entry:
Arrhythmia-
A-FibInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922892
Page 172 of 186
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
4. Start Date Time:
Date Location User Value Reason
Sep-11-2020 07:42:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-23-2020 04:39:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Charu
SabharwalQuery 1: Closed No further action
Sep-21-2020 12:27:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered It was resolved with
medication, how
would you like me to
proceed?
Sep-18-2020 16:49:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery - Please
clarify if Aug 27 is
the end of AE Atrial
Fibrillation (subject
in normal sinus
rhythm), or is the end
of 1st hospitalization.
If A Fib persists on
Aug 27, please update
AE end date here and
with a SAE followup.
Sep-11-2020 07:42:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/27/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-11-2020 07:42:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922893
Page 173 of 186
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
Sep-14-2020 05:42:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-12-2020 08:10:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: For AE
Arrhythmia- A-Fib :
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank. Please
consider to update as
appropriate. Thank
you.
Sep-11-2020 07:42:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Arrhythmia-
A-Fib : Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Sep-11-2020 07:42:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated wi
th congenital anomaly or birth de
fect?
NO
Did this serious event result in de
ath?
NO
Did this serious event require or p
rolong hospitalization?
YES
Did this serious event result in peInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922894
Page 174 of 186
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
rsistent or significant disability/in
capacity?
NO
Is this serious event life threateni
ng?
NO
Other medically important seriou
s event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-11-2020 07:42:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-18-2020 16:43:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Sep-15-2020 07:33:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed causality updated in SDB.
Issue resolved
Sep-15-2020 07:32:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened causality updated in SDB.
Issue resolved
Sep-15-2020 07:29:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Original value is correct
Sep-15-2020 07:29:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is correct
Sep-14-2020 05:49:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE
RECON:AER#2020350164
causality was reported as
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922895
Page 175 of 186
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
RELATED to Safety DB;
however, NOT RELATED
on the AE CRF. Please
confirm and update.If
safety update is required
submit a follow-up SAE
form.
Sep-11-2020 13:07:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL Please send a
SAE update with the
investigator's assessment of
SAE relationship to study
medication (not yet
reported for safety
database)
Sep-11-2020 07:42:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
medical records being re
viewed not able to answe
r at this time.Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-11-2020 07:42:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-11-2020 07:42:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-11-2020 07:42:22
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0922896
Page 176 of 186
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-11-2020 07:42:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-11-2020 07:42:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-14-2020 05:42:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2020350164Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0922897
Page 177 of 186
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Sep-29-2020 14:27:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-29-2020 14:27:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-29-2020 14:27:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Elevated troponinInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-29-2020 14:27:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-29-2020 14:27:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/26/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-29-2020 14:27:37
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0922898
Page 178 of 186
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
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
Sep-29-2020 14:27:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-29-2020 14:27:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-02-2020 15:02:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-02-2020 13:25:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Oct-02-2020 13:18:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL As
elevated troponin
levels occurred
during A fib with
rapid heart rate,
consider if the cause
would be A fib or
should remain as
Unknown
Sep-29-2020 14:28:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:Changed Information
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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), (b) (6)
FDA-CBER-2021-5683-0922899
Page 179 of 186
***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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
OTHER
If Other, specify:
Unknown
Sep-29-2020 14:27:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-29-2020 14:27:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-29-2020 14:27:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-29-2020 14:27:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-29-2020 14:27:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-29-2020 14:27:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (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-2021-5683-0922900
Page 180 of 186
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021 15:54:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922901
Page 181 of 186
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-02-2021 12:55:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Feb-02-2021 08:54:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-02-2021 08:54:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Transcription Error
Jan-29-2021 13:53:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please confirm
correct selection has
been made on this
revax confirmation
page. Please refer to
pg 207 of CRF
guidelines
Jan-29-2021 09:11:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Candidate CLINQUERY:
Please confirm
correct selection has
been made on this
revax confirmation
page. Please refer to
pg 207 of CRF
guidelines
Jan-19-2021 15:54:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willing to retu
rn for Vaccination 3 OR otherwis
e not eligibleInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922902
Page 182 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-22-2021 09:31:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
Jan/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-22-2021 09:31:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
ASSESS ELIGIBILITY FOR ADDI
TIONAL VACCINATIONInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922903
Page 183 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Jan-22-2021 09:31:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
Not ApplicableInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922904
Page 184 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Jan-22-2021 09:31:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
Not ApplicableInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922905
Page 185 of 186
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-16-2020 10:34:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-19-2020 18:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-19-2020 16:05:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-07-2020 16:09:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/2/2020Changed Information
Oct-16-2020 10:34:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/9/2020Initial Entry
Aug-19-2020 18:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
Aug-19-2020 16:05:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922906
Page 186 of 186
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020 16:34:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae306f\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922907