125742 S1 M5 CRF c4591001 1092 10921187

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
191
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 191
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923914
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: 10921187 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
Sep/15/2020
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923915
Page 3 of 191
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10921187]
2.Birth Date: 1947
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923916
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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923917
Page 5 of 191
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923918
Page 6 of 191
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923919
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: 10921187 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:[asthma Controlled]
Start Date: UNK/UNK/2004
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[hypertension]
Start Date: Sep/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[coronary artery disease]
Start Date: Jan/10/2020
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[coronary artery bypass graft]
Start Date: Jan/10/2020
Ongoing: NO
End Date:
Jan/10/2020
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[transient ischemic attack]
Start Date: Dec/6/2013
Ongoing: NO
End Date:
Dec/6/2013
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923920
Page 8 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[atrial fibrillation]
Start Date: Jul/6/2020
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[insertion of intra-cardiac defibrillator]
Start Date: Jul/6/2020
Ongoing: NO
End Date:
Jul/6/2020
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[dyslipidemia]
Start Date: May/UNK/2010
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[type 2 diabetes]
Start Date: UNK/UNK/2003
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[obesity]
Start Date: UNK/UNK/2010
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[seasonal allergies]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923921
Page 9 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[insomnia]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923922
Page 10 of 191
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
2.Weight: [296.2]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [40.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923923
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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/15/2020
2.Randomization Number: [257715]
3.Randomization Group: [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923924
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: 10921187 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:
Sep/15/2020
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 [BN5X64]
5.bSample ID [BL9V1W]
5.cSample ID [BL9V1X]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923925
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: 10921187 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:
Sep/15/2020
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 [BM9KXB]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923926
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: 10921187 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: Sep/15/2020 11:06
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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923927
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: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923928
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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923929
Page 17 of 191
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Oct/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923930
Page 18 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
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 [BM9L1B]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923931
Page 19 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: 10921187 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/6/2020 10:49
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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923932
Page 20 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, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923933
Page 21 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, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/3/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[samples collected at visit 3 will be scanned into convalescent visit which also occurred
today]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923934
Page 22 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923935
Page 23 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: 10921187 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 [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923936
Page 24 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923937
Page 25 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: 10921187 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 [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923938
Page 26 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923939
Page 27 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: 10921187 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 [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923940
Page 28 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923941
Page 29 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/1/2020
2.Date of First Symptom Started: Oct/1/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/3/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
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.Symptoms - Other Text: [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923942
Page 30 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
 1.Oct/1/2020  SWABBED M
ATERIAL NASOPHARYNX  SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923943
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/1/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [NALT unknown]
9.Trade Name Other, Specify: [NALT unknown]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923944
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: 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: 10921187 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Swab collected at Visit 2 06Oct2020 can be used for Illness visit per Data Management
Query]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
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(b) (4)
FDA-CBER-2021-5683-0923945
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: 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: 10921187 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Swab collected at Visit 2 06Oct2020 can be used for Illness visit per Data Management
Query]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923946
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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: YES
Number of Visits or Contacts:
[1]
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?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923947
Page 35 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Oct/1/2020  NO
Discharge Date:
Oct/3/2020
 Repeating Pages
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923948
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Oct/1/2020
4.Ongoing? NO
Discharge Date:
Oct/3/2020
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923949
Page 37 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: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923950
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: 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: 10921187 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?
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923951
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923952
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***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: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923953
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: 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: 10921187 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:
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923954
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923955
Page 43 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923956
Page 44 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923957
Page 45 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923958
Page 46 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923959
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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: [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923960
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923961
Page 49 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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 % [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923962
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***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: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923963
Page 51 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: 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: 10921187 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): [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923964
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***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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923965
Page 53 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: 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: 10921187 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?
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923966
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***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: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923967
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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:
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923968
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/03/2020Form: 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923969
Page 57 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/03/2020Form: 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/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 [BSJR61]
5.bSample ID [BM9L81]
5.cSample ID [BSJR5R]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923970
Page 58 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923971
Page 59 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Unplanned Assessments
1.Assessments
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923972
Page 60 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, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923973
Page 61 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: 10921187 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: [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923974
Page 62 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: 10921187 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:
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923975
Page 63 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: 10921187 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 [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923976
Page 64 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
 1.ADVERSE EVEN
T 1  Congestive heart failu
re Oct/1/2020 01:0
0 NO
End Date Time:
Oct/3/2020 UNK:UNK
 Repeating
Pages
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923977
Page 65 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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)[Congestive heart failure]
4.Start Date Time: Oct/1/2020 01:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/3/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Progression of cardiovascular disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923978
Page 66 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020381765]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923979
Page 67 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: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923980
Page 68 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: 10921187 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[ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923981
Page 69 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923982
Page 70 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: 10921187 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: //
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923983
Page 71 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: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923984
Page 72 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: 10921187 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?
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923985
Page 73 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: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923986
Page 74 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: 10921187 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?
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923987
Page 75 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923988
Page 76 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923989
Page 77 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923990
Page 78 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: 10921187 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:
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923991
Page 79 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: 10921187 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?
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923992
Page 80 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923993
Page 81 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923994
Page 82 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923995
Page 83 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923996
Page 84 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: 10921187 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 [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923997
Page 85 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: 10921187 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 [ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923998
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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923999
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: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924000
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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/20/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924001
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: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924002
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: 10921187 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
[ ]
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924003
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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/3/2020
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924004
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: 10921187 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
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924005
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: 10921187 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-04-2021 14:41:26 (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.
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924006
Page 94 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormSep-15-2020 11:12:51 (UTC-05:00) Eastern Time
(US & Canada)All inclusion and exclusion criteria met
Not Applicable
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924007
Page 95 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormNov-04-2020 10:30:06 (UTC-05:00) Eastern Time
(US & Canada)both visits occurred same day
FormNov-03-2020 10:47:48 (UTC-05:00) Eastern Time
(US & Canada)samples collected at visit 3 will be scanned into
convalescent visit which also occurred today
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924008
Page 96 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormNov-03-2020 10:47:32 (UTC-05:00) Eastern Time
(US & Canada)samples collected at visit 3 will be scanned into
convalescent visit which also occurred today
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924009
Page 97 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormOct-26-2020 08:25:48 (UTC-05:00) Eastern Time
(US & Canada)Swab collected at Visit 2 06Oct2020 can be used
for Illness visit per Data Management Query
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924010
Page 98 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormOct-26-2020 08:18:24 (UTC-05:00) Eastern Time
(US & Canada)Trade name unknown
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924011
Page 99 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormJan-21-2021 08:01:16 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924012
Page 100 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Jan-21-2021 08:01:16 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924013
Page 101 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormJan-21-2021 08:01:26 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924014
Page 102 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Jan-21-2021 08:01:26 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924015
Page 103 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: 10921187 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-04-2021 14:41:26 (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-21-2021 08:01:09 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-17-2020 14:15:31 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-17-2020 08:23:44 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-08-2020 13:41:42 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3072\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-2021-5683-0924016
Page 104 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: 10921187 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.
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924017
Page 105 of 191
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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
Sep-15-2020 11:11:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-15-2020 11:11:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924018
Page 106 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-15-2020 11:11:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/15/2020Initial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924019
Page 107 of 191
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-03-2020 08:47:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed AE entered
Oct-02-2020 12:06:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Oct-02-2020 09:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020381765
Shortness of breath(onset
01Oct2020)was reported as
serious in Safety database
but missing in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Sep-15-2020 11:11:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10921187Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-15-2020 11:11:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1947Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-15-2020 11:12:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-15-2020 11:12:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
090177e196ae3072\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), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924020
Page 108 of 191
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-15-2020 11:12:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924021
Page 109 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-15-2020 11:12:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924022
Page 110 of 191
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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
Sep-15-2020 11:13:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-15-2020 11:13:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-15-2020 11:13:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924023
Page 111 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Sep-15-2020 13:02:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:asthma Controll
ed
Start Date: UNK/UNK/200
4
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-15-2020 13:02:52
(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
Sep-15-2020 13:02:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
asthma ControlledInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-15-2020 13:02:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-15-2020 13:02:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-15-2020 13:03:41 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3072\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-2021-5683-0924024
Page 112 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern Time
(US & Canada)(autocalc) Line/MH Number: 2
Medical History Ter
m:hypertension
Start Date: Sep/UNK/201
0
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Sep-15-2020 13:03:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 13:03:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
hypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-15-2020 13:03:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-15-2020 13:03:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-15-2020 13:04:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:coronary artery di
sease
Start Date: Jan/10/2020
Ongoing: YESInitial Entry
090177e196ae3072\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-2021-5683-0924025
Page 113 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.c Line/MH Number:
Date Location User Value Reason
Sep-15-2020 13:04:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 13:04:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
coronary artery diseaseInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-15-2020 13:04:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/10/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-15-2020 13:04:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-15-2020 13:05:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:coronary artery byp
ass graft
Start Date: Jan/10/2020
Ongoing: NO
End Date:
Jan/10/2020Initial Entry
090177e196ae3072\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-2021-5683-0924026
Page 114 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.d Line/MH Number:
Date Location User Value Reason
Sep-15-2020 13:05:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 13:05:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
coronary artery bypass graftInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-15-2020 13:05:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/10/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-15-2020 13:05:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/10/2020Initial Entry
1.e
Date Location User Value Reason
Sep-15-2020 13:10:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:transient ischemic
attack
Start Date: Dec/6/2013
Ongoing: NO
End Date:
Dec/6/2013Initial Entry
090177e196ae3072\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-2021-5683-0924027
Page 115 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.e Line/MH Number:
Date Location User Value Reason
Sep-15-2020 13:10:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 13:10:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
transient ischemic attackInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-15-2020 13:10:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/6/2013Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-15-2020 13:10:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Dec/6/2013Initial Entry
1.f
Date Location User Value Reason
Sep-15-2020 13:11:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:atrial fibrillatio
n
Start Date: Jul/6/2020
Ongoing: YESInitial Entry
090177e196ae3072\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-2021-5683-0924028
Page 116 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.f Line/MH Number:
Date Location User Value Reason
Sep-15-2020 13:11:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 13:11:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
atrial fibrillationInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-15-2020 13:11:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/6/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-15-2020 13:11:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-15-2020 13:19:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Histo
ry Term:insertion of intra-cardi
ac defibrillator
Start Date: Jul/6/2020
Ongoing: NO
End Date:
Jul/6/2020Initial Entry
090177e196ae3072\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-2021-5683-0924029
Page 117 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.g Line/MH Number:
Date Location User Value Reason
Sep-15-2020 13:19:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 13:19:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
insertion of intra-cardiac defibrillatorInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-15-2020 13:19:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/6/2020Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-15-2020 13:19:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jul/6/2020Initial Entry
1.h
Date Location User Value Reason
Sep-15-2020 13:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Ter
m:dyslipidemia
Start Date: May/UNK/201
0
Ongoing: YESInitial Entry
090177e196ae3072\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-2021-5683-0924030
Page 118 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.h Line/MH Number:
Date Location User Value Reason
Sep-15-2020 13:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 13:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
dyslipidemiaInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-15-2020 13:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
May/UNK/2010Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-15-2020 13:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-15-2020 13:23:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Ter
m:type 2 diabetes
Start Date: UNK/UNK/20
03
Ongoing: YESInitial Entry
090177e196ae3072\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-2021-5683-0924031
Page 119 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.i Line/MH Number:
Date Location User Value Reason
Sep-15-2020 13:23:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 13:23:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
type 2 diabetesInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-15-2020 13:23:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2003Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-15-2020 13:23:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Sep-15-2020 13:28:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Ter
m:obesity
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae3072\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-2021-5683-0924032
Page 120 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.j Line/MH Number:
Date Location User Value Reason
Sep-15-2020 13:28:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 13:28:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
obesityInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-15-2020 13:28:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-15-2020 13:28:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3072\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-2021-5683-0924033
Page 121 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.k
Date Location User Value Reason
Sep-15-2020 13:28:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 11
Medical History Ter
m:seasonal allergi
es
Start Date: UNK/UNK/20
05
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Sep-15-2020 13:28:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 13:28:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
seasonal allergiesInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-15-2020 13:28:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-15-2020 13:28:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Sep-15-2020 13:29:26
(UTC-05:00) Eastern TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 12Initial Entry
090177e196ae3072\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-2021-5683-0924034
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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada) Medical History Ter
m:insomnia
Start Date: UNK/UNK/20
17
Ongoing: YES
1.l Line/MH Number:
Date Location User Value Reason
Sep-15-2020 13:29:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 13:29:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
insomniaInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-15-2020 13:29:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-15-2020 13:29:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3072\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-2021-5683-0924035
Page 123 of 191
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Sep-15-2020 13:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-15-2020 13:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
296.2Initial Entry
3. Unit:
Date Location User Value Reason
Sep-15-2020 13:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-15-2020 13:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-15-2020 13:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-15-2020 13:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
40.2Initial Entry
7.a
090177e196ae3072\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-2021-5683-0924036
Page 124 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Sep-15-2020 13:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.3
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-15-2020 13:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-15-2020 13:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-15-2020 13:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-15-2020 13:32:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3072\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-2021-5683-0924037
Page 125 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-15-2020 13:33:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-15-2020 13:33:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
257715Initial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924038
Page 126 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020 11:13:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020 11:13:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-15-2020 11:14:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 11:13:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-15-2020 11:13:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-15-2020 11:14:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN5X64Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-15-2020 11:14:31 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0924039
Page 127 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern Time
(US & Canada)BN5X64
5.b
Date Location User Value Reason
Sep-15-2020 11:14:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9V1WInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-15-2020 11:14:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BL9V1WInitial Entry
5.c
Date Location User Value Reason
Sep-15-2020 11:14:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9V1XInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-15-2020 11:14:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BL9V1XInitial Entry
090177e196ae3072\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) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0924040
Page 128 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020 11:13:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020 11:13:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-15-2020 11:13:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 11:13:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-15-2020 11:13:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-15-2020 11:13:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM9KXBInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-15-2020 11:13:47 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0924041
Page 129 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern Time
(US & Canada)BM9KXB
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0924042
Page 130 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-15-2020 13:33:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-15-2020 13:33:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-15-2020 13:33:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-15-2020 13:33:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020 11:06Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-15-2020 13:33:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-15-2020 13:33:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3072\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-2021-5683-0924043
Page 131 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Sep-15-2020 13:33:43
(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
Sep-15-2020 13:33:43
(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
Sep-15-2020 13:33:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924044
Page 132 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: 10921187 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
Sep-15-2020 11:13:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924045
Page 133 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: 10921187 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-06-2020 10:35:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924046
Page 134 of 191
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Oct-06-2020 11:47:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
2.a
Date Location User Value Reason
Oct-06-2020 11:47:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.2
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-06-2020 11:47:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-06-2020 11:47:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-06-2020 11:47:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-06-2020 11:47:24
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3072\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-2021-5683-0924047
Page 135 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924048
Page 136 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 10:36:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 10:36:00
(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-06-2020 10:36:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-06-2020 10:36:00
(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-06-2020 10:36:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020 10:36:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM9L1BInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-06-2020 10:36:14 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0924049
Page 137 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern Time
(US & Canada)BM9L1B
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0924050
Page 138 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: 10921187 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-06-2020 11:47:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-06-2020 11:47:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-06-2020 11:47:49
(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-06-2020 11:47:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020 10:49Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-06-2020 11:47:49
(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-06-2020 11:47:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3072\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-2021-5683-0924051
Page 139 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-06-2020 11:47:49
(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-06-2020 11:47:49
(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-06-2020 11:47:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924052
Page 140 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, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-05-2020
00:54:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-04-2020
10:29:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredboth visits occurred same day
Nov-04-2020
05:47:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW5269790;The Date of
Visit at Visit
V3_MONTH1_POSTVAX2_L
is the same as the other Date
of Visit at Visit COVID_A1.
Please review for duplication
and update as appropriate.
Nov-03-2020
10:45:29
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Nov/3/
2020Initial Entry
090177e196ae3072\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)
FDA-CBER-2021-5683-0924053
Page 141 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, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-03-2020 10:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-03-2020 10:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020 08:09:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query.
Nov-04-2020 10:28:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered samples collected at
visit 3 will be scanned
into convalescent visit
which also occurred
today. Subject had
combo visit
Nov-04-2020 05:31:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-03-2020 10:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-03-2020 10:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/3/2020Initial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0924054
Page 142 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, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-03-2020 10:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
samples collected at visit 3 will be sca
nned into convalescent visit which also
occurred todayInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924055
Page 143 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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 03:50:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sandip
Namdeorao
SuryawanshiQuery 1: Closed Response satisfies
query
Oct-27-2020 08:25:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Nasal swab collected,
data recorded. Self
swab collected at V2
06Oct2020. Please
see CRF and
comments
Oct-27-2020 05:31:19
(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.
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-26-2020 08:16:14
(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.
Oct-26-2020 08:16:14
(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.
Oct-26-2020 08:16:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924056
Page 144 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-26-2020 08:16:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924057
Page 145 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolved:
Oct/3/2020Initial Entry
4.a
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924058
Page 146 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.b
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASE
D COUGH
Symptom P
resent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Oct-26-2020 08:16:42
(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
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREASED
SHORTNESS OF BREA
TH
Sympto
m Presen
t:YESInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924059
Page 147 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.c Symptoms:
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTNE
SS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:NOInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924060
Page 148 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.e Symptoms:
Date Location User Value Reason
Oct-26-2020 08:16:42
(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
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW LOSS OF TAST
E OR SMELL
Symptom P
resent:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Oct-26-2020 08:16:42
(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
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCREASE
D SORE THROAT
Symptom
Present:NOInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924061
Page 149 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.g Symptoms:
Date Location User Value Reason
Oct-26-2020 08:16:42
(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
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924062
Page 150 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.i Symptoms:
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-26-2020 08:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924063
Page 151 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Oct-26-2020 08:18:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924064
Page 152 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: 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: 10921187 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
Oct-26-2020 08:18:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-26-2020 08:18:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-26-2020 08:18:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-26-2020 08:18:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDROME
CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Oct-26-2020 08:18:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Oct-27-2020 06:41:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed requery on other
specify
Oct-26-2020 08:18:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Trade name known.
Form level comment
added
090177e196ae3072\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-2021-5683-0924065
Page 153 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-26-2020 08:18:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Trade Name is Other,
however Trade Name
Other, Specify is not
completed. Please
update.
Oct-26-2020 08:18:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-26-2020 08:18:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Oct-28-2020 03:51:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sandip
Namdeorao
SuryawanshiQuery 1: Closed Response satisfies
query
Oct-27-2020 07:15:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Oct-27-2020 07:15:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NALT unknownChanged Information
Oct-27-2020 06:40:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: As per CRF CR,
if trade name is not
known. Please update
"NALT Unknown in
the specified field,
Thank you.
Oct-26-2020 08:18:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Trade name UNKNOWNInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Nov-17-2020 09:28:49
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae3072\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) (4), (b) (6)
FDA-CBER-2021-5683-0924066
Page 154 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
Nov-17-2020 08:23:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Nov-17-2020 08:23:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NALT unknownInitial Entry
Nov-16-2020 15:27:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 1: Opened Trade Name is Other,
however Trade Name
Other, Specify is not
completed. Please
update the comment
NALT UNKNOWN
in this field.
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0924067
Page 155 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020 08:21:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020 08:21:25
(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
Oct-26-2020 08:21:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-26-2020 08:23:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-26-2020 08:23:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Swab collected at Visit 2 06Oct2020
can be used for Illness visit per Data
Management QuerySwab collected at
Visit 2 06Oct2020 can
be used for Illness
visit per Data
Management Query
Oct-26-2020 08:21:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Entered text has either
a carriage return (line
break) or extra spaces
at the end of the text
or between words.
Please correct by
removing all data in
the field and re-enter
without adding extra
spaces or using enter
or tab keys.
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924068
Page 156 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-26-2020 08:21:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Swab collected at Visit 2 06Oct2020
per Data Management query can als
o be used for Illness visitInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924069
Page 157 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020 08:23:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020 08:23:22
(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-26-2020 08:23:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-26-2020 08:23:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Swab collected at Visit 2 06Oct2020
can be used for Illness visit per Data
Management QueryInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924070
Page 158 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Oct-26-2020 08:24:05
(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
Oct-26-2020 08:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-26-2020 08:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-26-2020 08:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitio
ner:EMERGENCY
ROOM
Occurrence of Vi
sits or Contacts:YES
Number of Visit
s or Contacts:
1Initial Entry
090177e196ae3072\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-2021-5683-0924071
Page 159 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-26-2020 08:24:05
(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
Oct-26-2020 08:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.c
Date Location User Value Reason
Oct-26-2020 08:24:05
(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
Oct-26-2020 08:24:05
(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
Oct-26-2020 08:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Oct-26-2020 08:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: URGENT
CAREInitial Entry
090177e196ae3072\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-2021-5683-0924072
Page 160 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Occurrence of Visits o
r Contacts:NO
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-26-2020 08:24:05
(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
Oct-26-2020 08:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-26-2020 08:24:05
(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
Oct-26-2020 08:24:05
(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
Oct-26-2020 08:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-26-2020 08:24:05
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTHEInitial Entry
090177e196ae3072\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-2021-5683-0924073
Page 161 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada) R
Occurrence of Visits or Co
ntacts:NO
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-26-2020 08:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-26-2020 08:24:05
(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
Oct-26-2020 08:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Has the subject been in intensive ca
re due to potential COVID-19 illnes
s?
NOInitial Entry
090177e196ae3072\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-2021-5683-0924074
Page 162 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Nov-06-2020 13:45:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924075
Page 163 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: HOSPITALIZATION DETAILS - 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Nov-06-2020 13:45:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Nov-06-2020 13:45:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HOSPITALInitial Entry
3. Admission Date:
Date Location User Value Reason
Nov-16-2020 15:06:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed E mailed CRA.
Nov-16-2020 13:32:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered Subject started with
shortness of breath,
later diagnosed with
Congestive Heart
Failure. SAE was
submitted and all
additional follow-ups
have also been
submitted.
Nov-16-2020 12:04:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened CLIQUERY: No
hospitalization
information that has
been received per
discrepancy response
is entered. Please
clarify or enter?
Nov-16-2020 11:08:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered All information
received has been
entered
Nov-16-2020 08:47:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened CLIQUERY:
Hospitalization: This
subject had
COVID-19 Illness and
090177e196ae3072\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-2021-5683-0924076
Page 164 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: HOSPITALIZATION DETAILS - 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
was hospitalized.
Please enter any
available information
(vital signs, pulse
oxymet, respiratory
treatment, lab results,
imaging…). Please
make every effort to
obtain these
information.
Nov-10-2020 13:55:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-10-2020 13:36:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Medical records were
requested and
received. Vital signs,
pulse oxymet, ect
were not listed in
reports.
Nov-10-2020 11:56:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLIQUERY:
Hospitalization: This
subject had
COVID-19 Illness and
was hospitalized.
Please enter any
available information
(vital signs, pulse
oxymet, respiratory
treatment, lab results,
imaging…). Please
make every effort to
obtain these
information.
Nov-06-2020 13:45:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
4. Ongoing?
Date Location User Value Reason
Nov-06-2020 13:45:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Discharge Date:
Oct/3/2020Initial Entry
090177e196ae3072\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-2021-5683-0924077
Page 165 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/01/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 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
Oct-26-2020 08:24:26
(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
Oct-26-2020 08:24:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-26-2020 08:24:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924078
Page 166 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/03/2020Form: 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-05-2020
00:54:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-04-2020
10:30:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredboth visits occurred same day
Nov-04-2020
05:47:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5269789;The Date of
Visit at Visit COVID_A1 is the
same as the other Date of Visit
at Visit
V3_MONTH1_POSTVAX2_L.
Please review for duplication
and update as appropriate.
Nov-03-2020
10:48:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Nov/3
/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-03-2020 10:48:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae3072\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)
FDA-CBER-2021-5683-0924079
Page 167 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/03/2020Form: 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-03-2020 10:48:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-03-2020 10:48:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-03-2020 10:55:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-03-2020 10:48:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-03-2020 10:48:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/3/2020Initial Entry
5.a
Date Location User Value Reason
Nov-03-2020 10:55:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSJR61Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-03-2020 10:55:23 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0924080
Page 168 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/03/2020Form: 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern Time
(US & Canada)BSJR61
5.b
Date Location User Value Reason
Nov-03-2020 10:55:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM9L81Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-03-2020 10:55:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BM9L81Initial Entry
5.c
Date Location User Value Reason
Nov-03-2020 10:55:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSJR5RInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-03-2020 10:55:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSJR5RInitial Entry
090177e196ae3072\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-2021-5683-0924081
Page 169 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, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-06-2020 01:25:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-05-2020 14:27:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Nov-05-2020 14:27:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/3/2020Changed Information
Nov-05-2020 14:26:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 1: Opened As per CRF
guidelines, the
treatment period is
defined as 1st
vaccination visit
through the 1-month
post vaccination visit
after the 2nd
vaccination. Please
complete treatment
disposition CRF and
update date of EOT to
match the date of
Visit 3.
Oct-16-2020 11:11:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020 11:11:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020 11:11:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0924082
Page 170 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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Oct-02-2020 11:28:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924083
Page 171 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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Oct-02-2020 11:28:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-02-2020 11:28:53
(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
Oct-26-2020 22:34:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 4: Closed Response satisfies query
Oct-26-2020 08:29:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered Visit added
Oct-25-2020 18:17:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 4: Reissued:Opened Clin: Please complete the
potential COVID Illness
Visit CRF forms for
SHORTNESS OF
BREATH. The nasal swab
taken in clinic at V2 can
count for these symptoms
please enter the same
barcode on the potential
COVID illness CRF
TRACKING - NASAL
SWAB
Oct-21-2020 08:40:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered Per source AE is correct as
Congestive Hearth Failure
Oct-17-2020 11:41:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 4: Opened Clin: Please complete the
potential COVID Illness
Visit CRF forms for
SHORTNESS OF
BREATH. The nasal swab
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0924084
Page 172 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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
taken in clinic at V2 can
count for these symptoms
please enter the same
barcode on the potential
COVID illness CRF
TRACKING - NASAL
SWAB
Oct-17-2020 11:37:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies query
Oct-16-2020 15:17:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Reissued:Opened Clin: please COVID-19
listed symptom
SHORTNESS OF
BREATH should have
triggered a potential
COVID Illness Visit
irrespective of the result of
a local SARS-COV-2
NAAT test result
Oct-16-2020 09:37:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered The patient went directly to
the hospital and was
admitted, swab there was
negative.
Oct-16-2020 07:17:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Reissued:Opened Clin: please COVID-19
listed symptom
SHORTNESS OF
BREATH should have
triggered a potential
COVID Illness Visit
irrespective of perceived
etiology or clinical
significance.
Oct-15-2020 08:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Correct as is per source.
Oct-13-2020 06:45:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed shortness of breath
removed in SDB
Oct-12-2020 00:11:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Reissued:Opened Clin: Despite a negative
test result, COVID-19
listed symptom
SHORTNESS OF
BREATH should please
trigger a potential COVID
Illness Visit irrespective of
perceived etiology or
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0924085
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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
clinical significance and a
NASAL SWAB needs to be
collected ASAP
Oct-11-2020 09:33:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Candidate pending SDB update
Oct-09-2020 14:00:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered shortness of breath is the
symptom of congestive
heart failure, new follow up
report form being sent
today (09Oct2020)
Oct-08-2020 12:52:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened Thank you for your
response, can you please
clarify if the SAE is now
updated to 'Congestive
Heart Failure' only and the
'Shortness of Breath' was a
Symptom of the disease?
Or if both conditions
should be reported and if so
please report AE for
Dyspnea.
Oct-08-2020 10:14:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered The updated SAE form
indicating congestive heart
failure was sent 05Oct2020
Oct-08-2020 05:47:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened SAE RECON 1:Term was
updated to congestive heart
failure however,Shortness
of breath still reported in
Safety database.Please
confirm if it should be
recorded as a separate entry
in AE CRF.Otherwise,a
follow up AEM form is
needed to downgrade event
in SDB
Oct-07-2020 14:40:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered New Information
Oct-07-2020 14:40:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Congestive heart failureNew Information
Oct-07-2020 06:33:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened SAE
RECON:AER#2020381765
additional event of
090177e196ae3072\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-2021-5683-0924086
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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
congestive heart
failure(onset
date:01Oct2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-07-2020 06:33:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed corrected onset date
Oct-07-2020 06:31:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE
RECON:AER#2020381765
additional event of
congestive heart
failure(onset
date:17Aug2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-06-2020 17:08:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered subject was hospitalized
and COVID-19 test done in
hospital was negative
Oct-02-2020 13:33:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: Per protocol section
8.1., COVID-19 listed
symptom SHORTNESS OF
BREATH should please
trigger a potential COVID
Illness Visit irrespective of
perceived etiology or
clinical significance and a
NASAL SWAB needs to be
collected ASAP
Oct-02-2020 11:28:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Shortness of breathInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-02-2020 11:28:53
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
Oct/1/2020 01:00Initial Entry
090177e196ae3072\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) (4), (b) (6)
FDA-CBER-2021-5683-0924087
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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada)
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-15-2020 08:05:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/3/2020 UNK:UNKNew Information
Oct-02-2020 11:28:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-02-2020 11:28:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-03-2020 00:46:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Query closed; will
follow for SAE update
with the requested
COVID test info
Nov-02-2020 17:04:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered Follow-Up SAE being
submitted
Oct-30-2020 21:09:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened Clinical - Thank you.
Please submit the
COVID test date of Oct
1 as a SAE safety
update
Oct-30-2020 08:01:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered Covid test collected
01Oct2020 results on
20Oct2020
090177e196ae3072\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-2021-5683-0924088
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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-29-2020 00:46:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened Clinical - querying
about the DATE for
COVID test - not listed
in Lab section (please
add 02Oct20 there).
Narrative says
Admitted 01Oct20 and
then ICU + COVID
test; thus suggests
01Oct20 rather than
02Oct20.
Oct-27-2020 08:21:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered Follow-Up SAE form
submitted 05Oct2020.
Results on page 11 of
12
Oct-26-2020 16:01:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened Clinical - Thank you.
Thank you. Please
report the COVID test
result and date
performed on a
follow-up SAE form
[lab test section;
AER#2020381765] as
a pertinent negative
test result for this trial.
Oct-23-2020 06:48:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered Hospital Covid Test
02Oct2020- Negative
Oct-21-2020 10:49:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened Please add date for
hospital COVID test to
SAE report, if known
(hospitalization start on
Oct 1, so likely Oct 1
or 2), in a SAE safety
update
Oct-03-2020 07:02:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-02-2020 11:28:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Shortness of
breath: Response to "Is
the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
090177e196ae3072\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-2021-5683-0924089
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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-02-2020 11:28:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated wit
h congenital anomaly or birth defe
ct?
NO
Did this serious event result in dea
th?
NO
Did this serious event require or p
rolong hospitalization?
YES
Did this serious event result in per
sistent or significant disability/inc
apacity?
NO
Is this serious event life threatenin
g?
NO
Other medically important serious
event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-02-2020 11:28:53
(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
Nov-05-2020
19:18:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Close
dResponse
satisfies query
090177e196ae3072\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-2021-5683-0924090
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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-05-2020
06:53:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answ
eredEverything is
correct as is and
up to date on
AE's and medical
history
Nov-04-2020
20:00:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 2: Opene
dPlease review "If
not related to
study treatment
other" field, the
following text
was indicated in
the comment
field
[cardiovascular
disease]. Any
symptoms, AEs
or other key data
should be
collected on the
appropriate page.
Please review
and update as
necessary.
Oct-18-2020
21:20:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Close
dResponse
satisfies query
Oct-15-2020
09:47:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATE
D
If Not Related
to study treat
ment(s), this e
vent is due to:
OTHER
If Other, sp
ecify:
Progressi
on of car
diovascul
ar diseas
eNew Information
090177e196ae3072\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-2021-5683-0924091
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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-15-2020
08:07:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answ
eredCorrect as is.
event is not
related to study
drug. Exact
cause of the CHF
is unknown.
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924092
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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-13-2020 12:57:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL Other
cause for CHF event
is Unknown;
however, subject has
a history of diabetes,
HTN, dyslipidemia,
known CAE and
CABG x5. Please
review the CV disease
history as a possible
basis for CHF, and
update if appropriate
Oct-02-2020 11:28:53
(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:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-07-2020 02:12:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query.
Oct-06-2020 17:10:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Oct-05-2020 05:06:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Please update
missing information
on field #11. Thank
you.
Oct-02-2020 11:28:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3072\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-2021-5683-0924093
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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-06-2020 17:10:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-02-2020 11:28:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-15-2020 08:10:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Closed Response satisfies query
Oct-15-2020 08:05:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Closed Close Auto Query
Oct-15-2020 08:05:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Opened For AE Congestive heart failure:
Response to "What was the outcome
of this adverse event?" is 3 but End
Date/Time is missing.
Oct-15-2020 08:05:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Answered New Information
Oct-15-2020 08:05:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVE
DNew Information
Oct-13-2020 05:33:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Opened SAE RECON:AER#2020381765 ,
Outcome was updated to
RECOVERING/RESOLVING in
AE CRF but was reported as
Recovered/resolved in SDB.Please
confirm correct outcome. If safety
update is required, please submit a
follow-up AEM form.
Oct-08-2020 12:56:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies query
Oct-08-2020 12:53:24 ACV0PFEINFP6000  Query 4: Closed Response satisfies query
090177e196ae3072\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) (4), (b) (6)
FDA-CBER-2021-5683-0924094
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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)
Oct-08-2020 10:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered Recovering reflects the last SAE
form and data received that was sent
05Oct2020
Oct-08-2020 10:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Answer Auto Query
Oct-08-2020 10:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLV
INGRecovering reflects the last SAE
form and data received that was sent
05Oct2020
Oct-08-2020 05:49:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened SAE RECON:AER#2020381765
,outcome was reported as
Recovering/Resolving to Safety DB
however, recorded as UNKNOWN
on AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
AEM form.
Oct-08-2020 05:21:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opene
dResponse does not satisfy query
Oct-08-2020 04:56:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Term update
Oct-07-2020 14:42:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Original value is correct
Oct-07-2020 14:41:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened For AE Congestive heart failure:
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".
Oct-07-2020 14:41:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNKNOWNTranscription Error
Oct-07-2020 10:31:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Answer Auto Query
Oct-07-2020 10:31:02
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVChanged Information
090177e196ae3072\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) (4), (b) (6)
FDA-CBER-2021-5683-0924095
Page 183 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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada) ING
Oct-07-2020 09:43:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opene
dDM:For AE Shortness of breath:
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".
Oct-07-2020 04:40:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Oct-06-2020 17:10:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Changed data per query
Oct-06-2020 17:09:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE Shortness of breath:
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".
Oct-06-2020 17:09:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-06-2020 17:09:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNKNOWNNew Information
Oct-03-2020 07:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020381765,outcome
was reported as UNKNOWN to
Safety DB however, recorded as
NOT RECOVERED/NOT
RESOLVED on AE CRF. Please
confirm correct outcome. If safety
update is required, please submit a
follow-up form.
Oct-02-2020 11:28:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT
RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-02-2020 11:28:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3072\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-2021-5683-0924096
Page 184 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, Locked, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-03-2020 07:02:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020381765Initial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924097
Page 185 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: 10921187 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-21-2021 08:01:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/20/2021Initial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924098
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: 10921187 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-01-2021 15:44:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Feb-01-2021 15:34:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-01-2021 15:34:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for Va
ccination 3
Participant is:
eligible and NOT confirmed to h
ave received only placebo at Vac
cination 1/2Transcription Error
Feb-01-2021 08:42:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY: Please
confirm correct
selection has been
made on this revax
confirmation page.
Please refer to pg 207
of CRF guidelines
Jan-21-2021 08:01:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is NOT willing to return
for Vaccination 3 OR otherwise not
eligibleInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0924099
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: 10921187 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-21-2021 08:01:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/20/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-21-2021 08:01:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR ADDI
TIONAL VACCINATIONInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924100
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: 10921187 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-21-2021 08:01:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924101
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: 10921187 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-21-2021 08:01:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924102
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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-16-2020 11:11:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-15-2020 13:33:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-15-2020 11:13:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-05-2020 14:27:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/3/2020Changed Information
Oct-16-2020 11:11:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/6/2020Initial Entry
Sep-15-2020 13:33:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/15/2020Initial Entry
Sep-15-2020 11:13:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/15/2020Initial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924103
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: 10921187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-08-2020 13:05:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3072\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924104
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