Document text
Page 1 of 191
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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
version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924105
Page 2 of 191
***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: 10921208 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
Oct/7/2020
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924106
Page 3 of 191
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10921208]
2.Birth Date: /1984
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924107
Page 4 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924108
Page 5 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924109
Page 6 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924110
Page 7 of 191
***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: 10921208 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:[obesity]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924111
Page 8 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924112
Page 9 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Oct/7/2020
2.Weight: [205.4]
3.Unit: LB
4.Height: [63.0]
5.Unit: in
6.Body Mass Index: [36.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924113
Page 10 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/7/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924114
Page 11 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/7/2020
2.Randomization Number: [104657]
3.Randomization Group: [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924115
Page 12 of 191
***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: 10921208 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:
Oct/7/2020
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 [BM9L1Z]
5.bSample ID [BL9V3W]
5.cSample ID [BL9V3X]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924116
Page 13 of 191
***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: 10921208 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/7/2020
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 [BM9L25]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924117
Page 14 of 191
***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: 10921208 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: Oct/7/2020 10:47
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
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924118
Page 15 of 191
***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: 10921208 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
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924119
Page 16 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924120
Page 17 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Oct/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924121
Page 18 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/28/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924122
Page 19 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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/28/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9L6Y]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924123
Page 20 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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: Oct/28/2020 14:58
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
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924124
Page 21 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/3/2020
2.Erroneous Visit
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924125
Page 22 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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:
Dec/3/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNVLFN]
5.bSample ID [BM9LCX]
5.cSample ID [BNVLFD]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924126
Page 23 of 191
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924127
Page 24 of 191
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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 [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924128
Page 25 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924129
Page 26 of 191
***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: 10921208 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 [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924130
Page 27 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924131
Page 28 of 191
***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: 10921208 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 [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924132
Page 29 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: DATE OF VISIT - ILLNESS ONSET
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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/24/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924133
Page 30 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/24/2021
2.Date of First Symptom Started: Jan/24/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/24/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Body Aches]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924134
Page 31 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Locat
ionAssay Code and Descripti
onDevice Type Form Instance
1.Not Applicable Not Applicabl
e Not Applicable Not Applicable Not Applicabl
e Repeating
Pages
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924135
Page 32 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924136
Page 33 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 10921208 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_SELF
3.Sample Collected? YES
Date of Collection:
Jan/27/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV03160]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924137
Page 34 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: 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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Subject collected self swab] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924138
Page 35 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924139
Page 36 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924140
Page 37 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924141
Page 38 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924142
Page 39 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924143
Page 40 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924144
Page 41 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
1. Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924145
Page 42 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924146
Page 43 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924147
Page 44 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924148
Page 45 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924149
Page 46 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924150
Page 47 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924151
Page 48 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924152
Page 49 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924153
Page 50 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924154
Page 51 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924155
Page 52 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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.Start Date: //
6.Ongoing?
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924156
Page 53 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924157
Page 54 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924158
Page 55 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Feb/24/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924159
Page 56 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Feb/24/2021Form: 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: 10921208 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:
Feb/24/2021
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 [BSM62G]
5.bSample ID [BR96B0]
5.cSample ID [BSM629]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924160
Page 57 of 191
***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: 10921208 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:
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924161
Page 58 of 191
***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: 10921208 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 [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924162
Page 59 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924163
Page 60 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Unplanned Assessments
1.Assessments
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924164
Page 61 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 Exposure During Pregn
ancy Jan/16/2021 UNK:
UNK YES Repeating
Pages
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924165
Page 62 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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)[Exposure During Pregnancy]
4.Start Date Time: Jan/16/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
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:
[unplanned pregnancy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:UNKNOWN
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924166
Page 63 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924167
Page 64 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924168
Page 65 of 191
***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: 10921208 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[ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924169
Page 66 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924170
Page 67 of 191
***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: 10921208 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: //
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924171
Page 68 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924172
Page 69 of 191
***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: 10921208 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?
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924173
Page 70 of 191
***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: 10921208 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
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924174
Page 71 of 191
***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: 10921208 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?
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924175
Page 72 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924176
Page 73 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924177
Page 74 of 191
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924178
Page 75 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924179
Page 76 of 191
***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: 10921208 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:
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924180
Page 77 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924181
Page 78 of 191
***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: 10921208 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?
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924182
Page 79 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924183
Page 80 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924184
Page 81 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924185
Page 82 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924186
Page 83 of 191
***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: 10921208 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 [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924187
Page 84 of 191
***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: 10921208 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 [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924188
Page 85 of 191
***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: 10921208 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: [ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924189
Page 86 of 191
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924190
Page 87 of 191
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924191
Page 88 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/26/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924192
Page 89 of 191
***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: 10921208 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
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924193
Page 90 of 191
***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: 10921208 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
[ ]
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924194
Page 91 of 191
***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: 10921208 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 Dec/3/2020
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924195
Page 92 of 191
***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: 10921208 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
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924196
Page 93 of 191
***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: 10921208 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-08-2021 11:35:11 (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.
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924197
Page 94 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormOct-07-2020 11:05:55 (UTC-05:00) Eastern Time
(US & Canada)all inclusion and exclusion criteria met
Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924198
Page 95 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormJan-26-2021 11:27:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924199
Page 96 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Jan-26-2021 11:27:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924200
Page 97 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Jan-26-2021 11:27:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924201
Page 98 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Jan-26-2021 11:27:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924202
Page 99 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Jan-26-2021 11:27:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924203
Page 100 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5Jan-26-2021 11:27:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924204
Page 101 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Jan-26-2021 11:27:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924205
Page 102 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
7Jan-26-2021 11:27:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924206
Page 103 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
8Jan-26-2021 11:27:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924207
Page 104 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
9Jan-26-2021 11:27:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924208
Page 105 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: 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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormJan-29-2021 11:22:28 (UTC-05:00) Eastern Time
(US & Canada)
FormJan-28-2021 07:51:23 (UTC-05:00) Eastern Time
(US & Canada)Subject collected self swab
Not Done
FormJan-28-2021 07:51:00 (UTC-05:00) Eastern Time
(US & Canada)
FormJan-26-2021 11:27:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924209
Page 106 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Jan-29-2021 11:22:28 (UTC-05:00) Eastern Time
(US & Canada)
1Jan-28-2021 07:51:23 (UTC-05:00) Eastern Time
(US & Canada)Subject collected self swab
Not Done
1Jan-28-2021 07:51:00 (UTC-05:00) Eastern Time
(US & Canada)
1Jan-26-2021 11:27:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924210
Page 107 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Jan-29-2021 11:22:28 (UTC-05:00) Eastern Time
(US & Canada)
2Jan-28-2021 07:51:23 (UTC-05:00) Eastern Time
(US & Canada)Subject collected self swab
Not Done
2Jan-28-2021 07:51:00 (UTC-05:00) Eastern Time
(US & Canada)
2Jan-26-2021 11:27:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924211
Page 108 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Jan-29-2021 11:22:28 (UTC-05:00) Eastern Time
(US & Canada)
3Jan-28-2021 07:51:23 (UTC-05:00) Eastern Time
(US & Canada)Subject collected self swab
Not Done
3Jan-28-2021 07:51:00 (UTC-05:00) Eastern Time
(US & Canada)
3Jan-26-2021 11:27:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924212
Page 109 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Jan-29-2021 11:22:28 (UTC-05:00) Eastern Time
(US & Canada)
4Jan-28-2021 07:51:23 (UTC-05:00) Eastern Time
(US & Canada)Subject collected self swab
Not Done
4Jan-28-2021 07:51:00 (UTC-05:00) Eastern Time
(US & Canada)
4Jan-26-2021 11:27:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924213
Page 110 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Jan-29-2021 14:17:08 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924214
Page 111 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormJan-26-2021 14:54:45 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924215
Page 112 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Jan-26-2021 14:54:45 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924216
Page 113 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormJan-26-2021 14:54:55 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924217
Page 114 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Jan-26-2021 14:54:55 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924218
Page 115 of 191
***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: 10921208 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-08-2021 11:35:11 (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-26-2021 11:25:35 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-26-2021 10:56:14 (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 Dec-03-2020 14:16:11 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-10-2020 12:02:22 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924219
Page 116 of 191
***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: 10921208 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.
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924220
Page 117 of 191
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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
Oct-07-2020 11:04:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-07-2020 11:04:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924221
Page 118 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-07-2020 11:04:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/7/2020Initial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924222
Page 119 of 191
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-07-2020 11:04:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10921208Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-07-2020 11:04:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1984Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-07-2020 11:05:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-07-2020 11:05:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-07-2020 11:05:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924223
Page 120 of 191
***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: 10921208 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 11:05:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924224
Page 121 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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
Oct-07-2020 11:06:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-07-2020 11:06:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-07-2020 11:06:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924225
Page 122 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Oct-07-2020 11:31:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:obesity
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-07-2020 11:31:15
(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
Oct-07-2020 11:31:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
obesityInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-07-2020 11:31:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-07-2020 11:31:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924226
Page 123 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-07-2020 11:32:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be HIV
POSITIVEInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924227
Page 124 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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 11:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-07-2020 11:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
205.4Initial Entry
3. Unit:
Date Location User Value Reason
Oct-07-2020 11:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-07-2020 11:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
63.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-07-2020 11:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-07-2020 11:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
36.4Initial Entry
7.a
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924228
Page 125 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-07-2020 11:31:52
(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
7.a Record Identifier:
Date Location User Value Reason
Oct-07-2020 11:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-07-2020 11:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-07-2020 11:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-07-2020 11:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924229
Page 126 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-07-2020 11:06:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-07-2020 11:06:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-07-2020 11:06:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-07-2020 11:06:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-07-2020 11:06:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-07-2020 11:06:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924230
Page 127 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-07-2020 11:06:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-07-2020 11:06:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-07-2020 11:06:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924231
Page 128 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-07-2020 11:32:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-07-2020 11:32:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
104657Initial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924232
Page 129 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020 11:06:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020 11:06:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020 11:07:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-07-2020 11:06:49
(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.
Oct-07-2020 11:06:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020 11:07:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM9L1ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-07-2020 11:07:02
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
BM9L1ZInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924233
Page 130 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
5.b
Date Location User Value Reason
Oct-07-2020 11:07:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9V3WInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-07-2020 11:07:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BL9V3WInitial Entry
5.c
Date Location User Value Reason
Oct-07-2020 11:07:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9V3XInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-07-2020 11:07:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BL9V3XInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924234
Page 131 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020 11:07:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020 11:07:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020 11:08:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-07-2020 11:07:51
(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.
Oct-07-2020 11:07:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020 11:08:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM9L25Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-07-2020 11:08:07
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
BM9L25Initial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924235
Page 132 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924236
Page 133 of 191
***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: 10921208 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
Oct-07-2020 11:32:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-07-2020 11:32:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-07-2020 11:32:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-07-2020 11:32:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020 10:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-07-2020 11:32:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-07-2020 11:32:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924237
Page 134 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-07-2020 11:32:58
(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
Oct-07-2020 11:32:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-07-2020 11:32:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924238
Page 135 of 191
***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: 10921208 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
Oct-07-2020 11:06:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924239
Page 136 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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-28-2020 14:45:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
Oct/28/2020Initial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0924240
Page 137 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Oct-28-2020 14:51:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
Oct/28/2020Initial Entry
2.a
Date Location User Value Reason
Oct-28-2020 14:51:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
Record Identifier:: 1
Temperature: 98.5
Temperature Unit: F
Temperature Locatio
n::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-28-2020 14:51:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-28-2020 14:51:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
98.5Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-28-2020 14:51:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-28-2020 14:51:55
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Kofi Amoah Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0924241
Page 138 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924242
Page 139 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-28-2020 14:52:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-28-2020 14:52:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-28-2020 14:52:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
Oct/28/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-28-2020 14:52:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-28-2020 14:52:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-28-2020 14:52:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0924243
Page 140 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-28-2020 14:52:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-28-2020 14:52:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-28-2020 14:52:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
NEGATIVEInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0924244
Page 141 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020 15:32:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020 15:32:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020 15:33:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-28-2020 15:32:58
(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.
Oct-28-2020 15:32:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/28/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020 15:33:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM9L6YInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 15:33:20
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
BM9L6YInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924245
Page 142 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924246
Page 143 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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
Oct-28-2020 15:01:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-28-2020 15:01:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-28-2020 15:01:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-28-2020 15:01:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
Oct/28/2020 14:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-28-2020 15:01:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-28-2020 15:01:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0924247
Page 144 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-28-2020 15:01:24
(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
Oct-28-2020 15:01:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-28-2020 15:01:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kofi Amoah Data Entry:
YESInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0924248
Page 145 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User ValueReason
Dec-07-2020
02:28:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedClosed per SITE response,
added to PD tracker for
Clinical Review
Dec-04-2020
07:37:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredDate correct as is, subject was
unable to make original
appointment.
Dec-04-2020
02:20:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 1 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately.
Dec-03-2020
14:16:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Dec/3
/2020Initial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0924249
Page 146 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-03-2020 14:16:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-03-2020 14:16:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-03-2020 14:18:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-03-2020 14:16:22
(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.
Dec-03-2020 14:16:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/3/2020Initial Entry
5.a
Date Location User Value Reason
Dec-03-2020 14:18:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNVLFNInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-03-2020 14:18:07
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
BNVLFNInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924250
Page 147 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
5.b
Date Location User Value Reason
Dec-03-2020 14:18:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM9LCXInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-03-2020 14:18:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM9LCXInitial Entry
5.c
Date Location User Value Reason
Dec-03-2020 14:18:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNVLFDInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-03-2020 14:18:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNVLFDInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924251
Page 148 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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-27-2021 10:32:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-27-2021 01:33:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update as
appropriate.
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-26-2021 11:25:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the
Signs and Symptoms
form is missing.
Please review and
update as appropriate.
Jan-26-2021 11:25:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update as
appropriate.
Jan-26-2021 11:25:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/24/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-26-2021 11:25:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924252
Page 149 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/24/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/24/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolved:
Jan/24/2021Initial Entry
4.a
Date Location User Value Reason
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924253
Page 150 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.b
Date Location User Value Reason
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASE
D COUGH
Symptom Pr
esent:NOInitial Entry
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASE
D COUGH
Symptom Pr
esent:Initial Entry
4.b Symptoms:
Date Location User Value Reason
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASED
SHORTNESS OF BREA
TH
Sympto
m Presen
t:NOInitial Entry
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASED
SHORTNESS OF BREA
THInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924254
Page 151 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sympto
m Presen
t:
4.c Symptoms:
Date Location User Value Reason
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORTNES
S OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present:Initial Entry
4.d Symptoms:
Date Location User Value Reason
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924255
Page 152 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:NOInitial Entry
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:Initial Entry
4.e Symptoms:
Date Location User Value Reason
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCLE P
AINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW LOSS OF TAST
E OR SMELL
Symptom P
resent:NOInitial Entry
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW LOSS OF TAST
E OR SMELL
Symptom P
resent:Initial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924256
Page 153 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.f Symptoms:
Date Location User Value Reason
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCREASE
D SORE THROAT
Symptom
Present:NOInitial Entry
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCREASE
D SORE THROAT
Symptom
Present:Initial Entry
4.g Symptoms:
Date Location User Value Reason
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE THR
OATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924257
Page 154 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present:Initial Entry
4.h Symptoms:
Date Location User Value Reason
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present:Initial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924258
Page 155 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.i Symptoms:
Date Location User Value Reason
Jan-26-2021 11:26:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-26-2021 11:26:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Jan-26-2021 11:26:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Other: Body AchesInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Jan-26-2021 11:26:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Body AchesInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924259
Page 156 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Jan-26-2021 11:27:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-26-2021 11:27:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-26-2021 11:27:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Jan-26-2021 11:27:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Device Type:
Date Location User Value Reason
Jan-26-2021 11:27:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Trade Name:
Date Location User Value Reason
Jan-26-2021 11:27:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
7. Test Result:
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924260
Page 157 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Jan-26-2021 11:27:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Jan-26-2021 11:27:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Jan-26-2021 11:27:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924261
Page 158 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021 10:32:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021 10:32:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021 10:32:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-27-2021 10:32:04
(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.
Jan-27-2021 10:32:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/27/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021 10:32:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: CV03160Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-27-2021 10:32:59
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
CV03160Initial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924262
Page 159 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924263
Page 160 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-29-2021 11:22:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
Jan-29-2021 11:22:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-28-2021 07:51:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Jan-28-2021 07:51:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-26-2021 11:27:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 11:22:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
Jan-29-2021 11:22:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-28-2021 07:51:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Jan-28-2021 07:51:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-26-2021 11:27:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Sample Collected?
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924264
Page 161 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Jan-29-2021
15:18:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2: Cl
osedAuto closed by
Validation Check:
VC_BEETRK001_07
Jan-29-2021
11:22:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: An
sweredInitial Entry
Jan-29-2021
11:22:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
NOInitial Entry
Jan-29-2021
11:22:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:Initial Entry
Jan-29-2021
01:59:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2: Op
enedDMW7047441;Sample
Collected is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately, In the
case that the SWAB
PFE is not collected
and instead SELF
SWAB, this form is
still required indicating
“Sample Collected” as
NO and the reason.
Jan-28-2021
21:46:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: Cl
osedAuto closed by
Validation Check:
VC_BEETRK001_05
Jan-28-2021
15:41:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Re
issued:Open
edSample Collected is
not expected to be
Unknown or Not
Applicable. Please
update the form by
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0924265
Page 162 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
answering 'Yes' or 'No'.
Please review and
update appropriately or
clarify
Jan-28-2021
07:51:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: An
sweredcorrected
Jan-28-2021
07:51:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
Not DoneInitial Entry
Jan-28-2021
07:51:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:Initial Entry
Jan-27-2021
03:12:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: Op
enedDMW7004408;Sample
Collected is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Jan-26-2021
11:27:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
Not Applica
bleInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-29-2021 11:22:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Subject collected self swabInitial Entry
Jan-29-2021 11:22:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-28-2021 07:51:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(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)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924266
Page 163 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Jan-28-2021 07:51:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-26-2021 11:27:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924267
Page 164 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIAL
IST
Occurrence of Visits or
Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner
:EMERGENC
Y ROOM
Occurrence of Visit
s or Contacts:NOInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924268
Page 165 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:PRIMARY CAR
E PHYSICIAN
Occurrence of Vi
sits or Contacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: URGENT
CARE
Occurrence of Visits o
r Contacts:NOInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924269
Page 166 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:TELEPHONE C
ONSULTATION
Occurrence of Vi
sits or Contacts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or Co
ntacts:NOInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924270
Page 167 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Jan-26-2021 11:27:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924271
Page 168 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/24/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Jan-26-2021 11:27:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Jan-26-2021 11:27:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Jan-26-2021 11:27:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b)
(5)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924272
Page 169 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Feb/24/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021 11:03:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/24/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-24-2021 11:03:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924273
Page 170 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Feb/24/2021Form: 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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-24-2021 11:08:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-24-2021 11:08:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-24-2021 11:08:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-24-2021 11:08:10
(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.
Feb-24-2021 11:08:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/24/2021Initial Entry
5.a
Date Location User Value Reason
Feb-24-2021 11:08:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSM62GInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-24-2021 11:08:29
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
BSM62GInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924274
Page 171 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Feb/24/2021Form: 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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
5.b
Date Location User Value Reason
Feb-24-2021 11:08:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR96B0Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-24-2021 11:08:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR96B0Initial Entry
5.c
Date Location User Value Reason
Feb-24-2021 11:09:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSM629Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-24-2021 11:09:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BSM629Initial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924275
Page 172 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Jan-26-2021 14:54:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924276
Page 173 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Jan-26-2021 14:54:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-26-2021 14:54:12
(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
Mar-02-2021 15:49:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Feb-26-2021 13:32:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Answered Updated report sent
with LMP date,
known conception
date, and pregnancy
due date.
Feb-25-2021 10:51:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Opened CLINICAL Current
PG safety report has
MISSING for
REQUIRED items:
first day of LMP;
estimated Conception
date (with method for
calculating; e.g. was
this by OB
Ultrasound)
Feb-10-2021 11:14:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Feb-10-2021 11:14:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-10-2021 11:13:56
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924277
Page 174 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
Feb-09-2021 16:20:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answered Updated report sent
Feb-09-2021 16:20:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Updated report sent
Feb-09-2021 16:20:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Updated report sent
Jan-30-2021 22:55:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical Please submit
a PG safety update
reporting the outcome
of the subject's 3
previous pregnancies
Jan-30-2021 22:54:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical Please submit
Father information on
the Pregnancy form
(age, med hx, social
habits)
Jan-30-2021 22:42:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Clinical Thank you;
please submit a PG
safety update
reporting this revised
event term
Jan-29-2021 14:16:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-29-2021 14:16:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exposure During PregnancyTranscription Error
Jan-27-2021 14:00:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical As per CRF
CG 8.50.2.5, a healthy
pregnancy is not an
AE term; instead
“Exposure During
Pregnancy” will be
recorded as an AE on
CRF/safety report
until 6 months after
the last dose of study
intervention.
Jan-26-2021 14:54:12
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
PregnanyInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0924278
Page 175 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
4. Start Date Time:
Date Location User Value Reason
Mar-02-2021 15:49:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Feb-26-2021 13:31:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Answered Updated report sent
Feb-25-2021 10:50:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Opened Clinical Event start
date is 16Jan21;
however PG safety
report most recent
(24Feb21) has
25Jan21 (must
match). Please enter
revised start date in
Event section under
START.
Feb-25-2021 10:45:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Feb-24-2021 13:59:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answered Updated SAE forms
sent
Feb-23-2021 20:27:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical Event start
date is 16Jan21;
however PG safety
report has 25Jan21
(must match). LMP &
Conception dates
were removed from
PG Safety report;
some start date is
needed. Consider
subject's due date
(from OB, minus 40
weeks to approximate
Feb-23-2021 20:24:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed revising query
Feb-22-2021 15:58:14
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Query 2: Opened CLINICAL updated
start date is
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0924279
Page 176 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada) 16Jan2021 (estimated
date of conception);
however, the updated
start date was not yet
submitted to the PG
Safety report (which
still has 25Jan21).
Please submit PG
safety update with the
revised start date.
Feb-17-2021 23:01:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-17-2021 07:39:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-17-2021 07:39:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/16/2021 UNK:UNKNew Information
Feb-10-2021 11:16:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened CLINICAL Event
report already states
please LMP date
(30Dec20) and
Estimated date of
Conception
[16Jan21]; please
update currently to
one of these 2 dates
(can be updated later
w/Med records)
Feb-09-2021 16:22:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Will update after
records received
Jan-30-2021 22:51:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical For PG start
date, ultrasound
measurement of the
fetus during the first
trimester is the most
accurate method; in
the absence of US, the
1st day of the last
menstrual period
(LMP) should be used
to estimate conception
(not urine test date).
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924280
Page 177 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Jan-26-2021 14:54:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-26-2021 14:54:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-30-2021 22:42:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-29-2021 14:17:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-29-2021 14:16:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-29-2021 14:16:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-27-2021 14:01:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical As per CRF
CG 8.50.2.5, the
toxicity grade for
“Exposure During
Pregnancy” is
reported as Not
Applicable
Jan-26-2021 14:54:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924281
Page 178 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Feb-11-2021 04:54:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Deleted Close Auto Query
Feb-01-2021 09:19:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate For AE Exposure
During Pregnancy:
Response to "Is the
adverse event
serious?" is 'No' but
"Serious Adverse
Event Number" is
present.
Jan-30-2021 22:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Jan-29-2021 14:17:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Jan-29-2021 14:17:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-29-2021 14:17:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription Error
Jan-29-2021 14:16:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Exposure
During Pregnancy:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Jan-27-2021 14:00:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical As per CRF
CG 8.50.2.5, an
“Exposure During
Pregnancy” is not an
SAE [despite using
similar forms to report
pregnancy]; only
abnormal outcomes of
pregnancy are
evaluated for serious
criteria
Jan-26-2021 14:54:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Pregnany:
Response to "Is the
adverse event
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924282
Page 179 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Jan-26-2021 14:54:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated wit
h congenital anomaly or birth defec
t?
NO
Did this serious event result in deat
h?
NO
Did this serious event require or pr
olong hospitalization?
NO
Did this serious event result in pers
istent or significant disability/incap
acity?
NO
Is this serious event life threatening
?
NO
Other medically important serious
event
YESInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924283
Page 180 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
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
Jan-26-2021 14:54:12
(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
Jan-26-2021 14:54:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s)
, this event is due to:
OTHER
If Other, specify:
unplanned pregnancyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-26-2021 14:54:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-26-2021 14:54:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-26-2021 14:54:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924284
Page 181 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Feb-12-2021 16:09:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-12-2021 14:34:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-12-2021 10:29:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Changed
Feb-12-2021 10:28:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE Exposure
During Pregnancy:
Response to "What was
the outcome of this
adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse event
still ongoing?" is
marked "Yes".
Feb-12-2021 10:28:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Feb-12-2021 10:28:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNChanged Information
Feb-10-2021 22:57:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2021077885, the
outcome in AE CRF
was reported as NOT
RECOVERED/NOT
RESOLVED. Per 3
Nov EDP guidance ,
outcome should be
recorded as
UNKNOWN. Please
confirm and update
accordingly.
Jan-26-2021 14:54:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0924285
Page 182 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Jan-26-2021 14:54:12
(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
Feb-11-2021 04:54:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: downgraded to non
serious
Feb-01-2021 09:19:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2021077885Initial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924286
Page 183 of 191
***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, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921208 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
Dec-03-2020 14:19:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-03-2020 14:19:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-03-2020 14:19:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924287
Page 184 of 191
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled 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: 10921208 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-26-2021 14:55:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/26/2021Initial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924288
Page 185 of 191
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 10921208 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-09-2021 17:54:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Closed per site response -
deemed eligible at
time of revax.
Feb-09-2021 16:24:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Subject reported the
pregnancy after the
phone contact
Feb-09-2021 03:11:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINQUERY: It
appears subject
reported pregnancy at
the time of revax
review - pregnancy is
an exclusion from
further dosing on trial.
Please clarify this
entry and the
treatment unblind that
has reported to have
occurred.
Feb-08-2021 14:29:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Candidate CLINQUERY: It
appears subject
reported pregnancy at
the time of revax
review - pregnancy is
an exclusion from
further dosing on trial.
Please clarify this
entry and the
treatment unblind that
has reported to have
occurred.
Feb-02-2021 13:10:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Feb-02-2021 10:31:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-02-2021 10:31:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for Va
ccination 3Transcription Error
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924289
Page 186 of 191
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Participant is:
eligible and NOT confirmed to ha
ve received only placebo at Vacci
nation 1/2
Feb-02-2021 09:53:34
(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
Feb-01-2021 08:45:34
(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-26-2021 14:55:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willing to return
for Vaccination 3 OR otherwise not
eligibleInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924290
Page 187 of 191
***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: 10921208 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-26-2021 14:54:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/26/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-26-2021 14:54:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR ADDI
TIONAL VACCINATIONInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0924291
Page 188 of 191
***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: 10921208 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-26-2021 14:54:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924292
Page 189 of 191
***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: 10921208 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-26-2021 14:54:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924293
Page 190 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-03-2020 14:19:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-07-2020 11:32:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-07-2020 11:06:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-03-2020 14:19:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/3/2020Initial Entry
Oct-07-2020 11:32:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
Oct-07-2020 11:06:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924294
Page 191 of 191
***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: 10921208 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020 11:09:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3073\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924295