125742 S1 M5 CRF c4591001 1092 10921048

Document text

Page 1 of 244
***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: 10921048 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
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923153
Page 2 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/24/2020
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923154
Page 3 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10921048]
2.Birth Date: 1962
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:
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923155
Page 4 of 244
***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: 10921048 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 Aug/24/2020
2.Erroneous Visit
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923156
Page 5 of 244
***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: 10921048 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
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923157
Page 6 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923158
Page 7 of 244
***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: 10921048 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:[sleep apnea]
Start Date: UNK/UNK/1998
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2007
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[coronary artery disease]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923159
Page 8 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[myocardial infarction]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[percutaneous transluminal coronary angioplasty]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[stable angina]
Start Date: UNK/UNK/2009
Ongoing: YES
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923160
Page 9 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[dyslipidemia]
Start Date: UNK/UNK/1998
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[type 2 diabetes]
Start Date: UNK/UNK/2012
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[obesity]
Start Date: UNK/UNK/2007
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gastro esophageal reflux disease]
Start Date: UNK/UNK/1995
Ongoing: YES
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923161
Page 10 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
2.Weight: [311.4]
3.Unit: LB
4.Height: [70.5]
5.Unit: in
6.Body Mass Index: [44.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923162
Page 11 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/24/2020
2.Randomization Number: [238283]
3.Randomization Group: [ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923163
Page 12 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BL9TRM]
5.bSample ID [BL9TRN]
5.cSample ID [BN5WRF]
5.dSample ID [BN5WRG]
5.eSample ID [BN5WRH]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923164
Page 13 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BN5WPX]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923165
Page 14 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/24/2020 13:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923166
Page 15 of 244
***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: 10921048 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
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923167
Page 16 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923168
Page 17 of 244
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923169
Page 18 of 244
***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: 10921048 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/14/2020
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 [BM9KWR]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923170
Page 19 of 244
***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: 10921048 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/14/2020 11:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923171
Page 20 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923172
Page 21 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
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 [BM9L4H]
5.bSample ID [BL9V75]
5.cSample ID [BL9V76]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923173
Page 22 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923174
Page 23 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/16/2020
2.Date of First Symptom
Started:Nov/15/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/23/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923175
Page 24 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923176
Page 25 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Coll
ectionSpecimen
TypeSpecimen Collectio
n LocationAssay Code and D
escriptionDevice
TypeForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Don
e Repeating
Pages
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923177
Page 26 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923178
Page 27 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/16/2020
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 [CV23469]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923179
Page 28 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 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:[self swab collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923180
Page 29 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923181
Page 30 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923182
Page 31 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Treatment Ide
ntifierCon Non-Drug Treatments Pr
e-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923183
Page 32 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 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?
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923184
Page 33 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923185
Page 34 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category of Clinical
Event:Subcategory of Clinica
l EventDiagnosis Obta
inedToxicity Gr
adeForm Instanc
e
 1.        Repeating
Pages
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923186
Page 35 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 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:
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923187
Page 36 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category for
Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Define
d IdentifierTes
t:Res
ult:Repeating
Pages
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923188
Page 37 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 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
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923189
Page 38 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category fo
r Lab TestVendor Name
(DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923190
Page 39 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 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
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923191
Page 40 of 244
***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: 10921048 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
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923192
Page 41 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 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: [ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923193
Page 42 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923194
Page 43 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 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 % [ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923195
Page 44 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date Time of Assess
mentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled O
xygen)Form Instance
 1.      Repeating
Pages
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923196
Page 45 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 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):[ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923197
Page 46 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923198
Page 47 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 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?
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923199
Page 48 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Assessme
ntLocation of Assessm
entImaging Meth
odOverall Assessme
ntForm Instance
 1.        Repeating
Pages
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923200
Page 49 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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:
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923201
Page 50 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/14/2020Form: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/14/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923202
Page 51 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/14/2020Form: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/14/2020
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 [BNVLJ5]
5.bSample ID [BM9LF2]
5.cSample ID [BNVLHV]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923203
Page 52 of 244
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923204
Page 53 of 244
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Unplanned Assessments
1.Assessments
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923205
Page 54 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923206
Page 55 of 244
***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: 10921048 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: [ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923207
Page 56 of 244
***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: 10921048 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:
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923208
Page 57 of 244
***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: 10921048 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 [ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923209
Page 58 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#CategoryAE Iden
tifierAdverse E
ventStart DateIs the Adverse Event S
till OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Atrial Fibri
llation Nov/23/2020 U
NK:UNK NO
End Date Time:
Nov/25/2020 UNK:
UNK
 Repeating
Pages
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923210
Page 59 of 244
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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)[Atrial Fibrillation]
4.Start Date Time: Nov/23/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/25/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923211
Page 60 of 244
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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:
[Cardiac medical history]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923212
Page 61 of 244
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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[2020496910]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923213
Page 62 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication Er
rors ActionForm Instanc
e
 1.         Repeating
Pages
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923214
Page 63 of 244
***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: 10921048 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[ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923215
Page 64 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923216
Page 65 of 244
***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: 10921048 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: //
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923217
Page 66 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923218
Page 67 of 244
***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: 10921048 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?
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923219
Page 68 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Catego
ryTreatment Iden
tifierCon Non-Drug Treatments Pr
e-specifiedTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923220
Page 69 of 244
***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: 10921048 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?
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923221
Page 70 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923222
Page 71 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923223
Page 72 of 244
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923224
Page 73 of 244
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10921048 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:
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923225
Page 74 of 244
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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?
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923226
Page 75 of 244
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923227
Page 76 of 244
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923228
Page 77 of 244
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923229
Page 78 of 244
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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 per other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923230
Page 79 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/28/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923231
Page 80 of 244
***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: 10921048 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
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923232
Page 81 of 244
***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: 10921048 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
[ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923233
Page 82 of 244
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923234
Page 83 of 244
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/10/2021
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923235
Page 84 of 244
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923236
Page 85 of 244
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/10/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923237
Page 86 of 244
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/10/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSM61J]
5.bSample ID [BR969G]
5.cSample ID [BSM61C]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923238
Page 87 of 244
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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:
Feb/10/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9696]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923239
Page 88 of 244
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/10/2021 10:41
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923240
Page 89 of 244
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923241
Page 90 of 244
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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:
Mar/2/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRBT34]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923242
Page 91 of 244
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/2/2021 10:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923243
Page 92 of 244
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923244
Page 93 of 244
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923245
Page 94 of 244
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923246
Page 95 of 244
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923247
Page 96 of 244
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923248
Page 97 of 244
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923249
Page 98 of 244
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923250
Page 99 of 244
***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: 10921048 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 Oct/12/2020
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923251
Page 100 of 244
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10921048 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
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923252
Page 101 of 244
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-10-2021 11:54:45 (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.
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923253
Page 102 of 244
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormAug-24-2020 13:41:48 (UTC-05:00)
Eastern Time (US & Canada)All inclusion and exclusion criteria met
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923254
Page 103 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormAug-24-2020 13:42:34 (UTC-05:00)
Eastern Time (US & Canada)All inclusion and exclusion criteria met
Not Applicable
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923255
Page 104 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormNov-19-2020 07:24:29 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923256
Page 105 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Nov-19-2020 07:24:29 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923257
Page 106 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Nov-19-2020 07:24:29 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923258
Page 107 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Nov-19-2020 07:24:29 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923259
Page 108 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Nov-19-2020 07:24:29 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923260
Page 109 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5Nov-19-2020 07:24:29 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923261
Page 110 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Nov-19-2020 07:24:29 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923262
Page 111 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
7Nov-19-2020 07:24:29 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923263
Page 112 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
8Nov-19-2020 07:24:29 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923264
Page 113 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
9Nov-19-2020 07:24:29 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923265
Page 114 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormJan-29-2021 16:16:55 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923266
Page 115 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Jan-29-2021 16:16:55 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923267
Page 116 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormJan-29-2021 16:17:06 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923268
Page 117 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Jan-29-2021 16:17:06 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923269
Page 118 of 244
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormFeb-11-2021 06:51:01 (UTC-05:00)
Eastern Time (US & Canada)All criteria met.
Not Applicable
FormFeb-10-2021 11:51:36 (UTC-05:00)
Eastern Time (US & Canada)All criteria met.
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923270
Page 119 of 244
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-10-2021 11:54:45 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
 N/A Mar-02-2021 10:16:43 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-24-2021 14:10:36 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923271
Page 120 of 244
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
 N/A Jan-29-2021 16:16:47 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-22-2021 13:43:09 (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-19-2020 07:23:25 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923272
Page 121 of 244
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
N/A
 Approved Oct-22-2020 12:57:25 (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.
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923273
Page 122 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-24-2020
13:40:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-24-2020
13:40:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923274
Page 123 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-24-2020
13:40:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent
Obtained
Aug/24/2020Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923275
Page 124 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-24-2020
13:40:35
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10921048Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-24-2020
13:40:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1962Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-24-2020
13:41:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-24-2020
13:41:05ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923276
Page 125 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)ATINO(A) OR OF SPA
NISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-24-2020
13:41:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923277
Page 126 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-24-2020
13:41:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923278
Page 127 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-24-2020
13:42:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-24-2020
13:42:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-24-2020
13:42:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923279
Page 128 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Aug-24-2020
16:29:43
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:sleep apn
ea
Start Date: UNK/UN
K/1998
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-24-2020
16:29:43
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
16:29:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
sleep apneaInitial Entry
1.a Start Date:
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923280
Page 129 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Aug-24-2020
16:29:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-24-2020
16:29:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-24-2020
16:32:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:hypertens
ion
Start Date: UNK/UN
K/2007
Ongoing: YESInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923281
Page 130 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.b Line/MH Number:
Date Location User Value Reason
Aug-24-2020
16:32:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
16:32:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
hypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-24-2020
16:32:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-24-2020
16:32:34
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3070\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-2021-5683-0923282
Page 131 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
1.c
Date Location User Value Reason
Aug-24-2020
16:33:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical Hi
story Term:coronary ar
tery disease
Start Date: UNK/UNK
/2005
Ongoing: YESInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923283
Page 132 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.c Line/MH Number:
Date Location User Value Reason
Aug-24-2020
16:33:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
16:33:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
coronary artery diseaseInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-24-2020
16:33:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-24-2020
16:33:37
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3070\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-2021-5683-0923284
Page 133 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
1.d
Date Location User Value Reason
Aug-24-2020
16:34:24
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical Hi
story Term
:myocardial
infarction
Start Date: UNK/UNK/
2005
Ongoing: NO
End Date:
UNK/U
NK/2005Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923285
Page 134 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.d Line/MH Number:
Date Location User Value Reason
Aug-24-2020
16:34:24
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
16:34:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
myocardial infarctionInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-24-2020
16:34:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-24-2020
16:34:24
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae3070\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-2021-5683-0923286
Page 135 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada) UNK/UNK/2005
1.e
Date Location User Value Reason
Aug-24-2020
16:35:40
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:5
Medica
l Histor
y Term
:percutaneous tra
nsluminal coron
ary angioplasty
Start D
ate:UNK/UNK/200
9
Ongoin
g:NO
End Date:
UNK/UNK/2
009Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923287
Page 136 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.e Line/MH Number:
Date Location User Value Reason
Aug-24-2020
16:35:40
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
16:35:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
percutaneous translumi
nal coronary angioplast
yInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-24-2020
16:35:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-24-2020
16:35:40
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae3070\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-2021-5683-0923288
Page 137 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada) UNK/UNK/2009
1.f
Date Location User Value Reason
Aug-24-2020
16:36:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:stable ang
ina
Start Date: UNK/UN
K/2009
Ongoing: YESInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923289
Page 138 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.f Line/MH Number:
Date Location User Value Reason
Aug-24-2020
16:36:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
16:36:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
stable anginaInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-24-2020
16:36:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-24-2020
16:36:06
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3070\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-2021-5683-0923290
Page 139 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
1.g
Date Location User Value Reason
Aug-24-2020
16:36:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:dyslipide
mia
Start Date: UNK/UN
K/1998
Ongoing: YESInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923291
Page 140 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.g Line/MH Number:
Date Location User Value Reason
Aug-24-2020
16:36:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
16:36:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
dyslipidemiaInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-24-2020
16:36:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-24-2020
16:36:32
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3070\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-2021-5683-0923292
Page 141 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
1.h
Date Location User Value Reason
Aug-24-2020
16:37:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:type 2 dia
betes
Start Date: UNK/UN
K/2012
Ongoing: YESInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923293
Page 142 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.h Line/MH Number:
Date Location User Value Reason
Aug-24-2020
16:37:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
16:37:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
type 2 diabetesInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-24-2020
16:37:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-24-2020
16:37:04
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3070\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-2021-5683-0923294
Page 143 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
1.i
Date Location User Value Reason
Aug-24-2020
16:37:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9
Medical Hist
ory Term:obesity
Start Date: UNK/UN
K/2007
Ongoing: YESInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923295
Page 144 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.i Line/MH Number:
Date Location User Value Reason
Aug-24-2020
16:37:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
16:37:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
obesityInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-24-2020
16:37:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-24-2020
16:37:22
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3070\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-2021-5683-0923296
Page 145 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
1.j
Date Location User Value Reason
Aug-24-2020
16:38:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:10
Medical
History T
erm:gastro esoph
ageal reflux
disease
Start Dat
e:UNK/UNK/1
995
Ongoing: YESInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923297
Page 146 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.j Line/MH Number:
Date Location User Value Reason
Aug-24-2020
16:38:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
16:38:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
gastro esophageal reflu
x diseaseInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-24-2020
16:38:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-24-2020
16:38:15
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3070\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-2021-5683-0923298
Page 147 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923299
Page 148 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Aug-24-2020
16:26:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020
17:49:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Aug-25-2020
07:52:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Not Clinically
Significant
Aug-25-2020
06:23:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Reissued:
OpenedDM1: Kindly
confirm if the
Weight is
clinically
significant or
not and report
an AE in case
it is clinically
significant.
090177e196ae3070\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-2021-5683-0923300
Page 149 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Thank you.
Aug-24-2020
16:27:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Original value
is correct
Aug-24-2020
16:26:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Weight 311.4
is outside of
Normal Range
25 - 136 for kg
or 50 - 300 for
lb.
Aug-24-2020
16:26:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
311.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-24-2020
16:26:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-24-2020
16:26:27
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
70.5Initial Entry
090177e196ae3070\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-2021-5683-0923301
Page 150 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)
5. Unit:
Date Location User Value Reason
Aug-24-2020
16:26:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-24-2020
16:26:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
44.0Initial Entry
7.a
Date Location User Value Reason
Aug-24-2020
16:26:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Iden
tifier::1
Temperatur
e:98.5
Temperatur
e Unit:F
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923302
Page 151 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.a Record Identifier:
Date Location User Value Reason
Aug-24-2020
16:26:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-24-2020
16:26:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-24-2020
16:26:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-24-2020
16:26:27
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3070\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-2021-5683-0923303
Page 152 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923304
Page 153 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-24-2020
16:28:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-24-2020
16:28:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
238283Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923305
Page 154 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020
13:43:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020
13:43:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020
13:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-24-2020
13:43:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923306
Page 155 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
review and
correct as
appropriate.
Aug-24-2020
13:43:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-24-2020
13:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9TRMInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-24-2020
13:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BL9TRMInitial Entry
5.b
Date Location User Value Reason
Aug-24-2020
13:44:32
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Sample ID: BL9TRNInitial Entry
090177e196ae3070\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-2021-5683-0923307
Page 156 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
5.b Sample ID
Date Location User Value Reason
Aug-24-2020
13:44:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BL9TRNInitial Entry
5.c
Date Location User Value Reason
Aug-24-2020
13:44:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN5WRFInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-24-2020
13:44:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN5WRFInitial Entry
5.d
Date Location User Value Reason
Aug-24-2020
13:45:07ACV0PFEINFP6000  Data Entry:
Sample ID: BN5WRGInitial Entry
090177e196ae3070\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-2021-5683-0923308
Page 157 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)
5.d Sample ID
Date Location User Value Reason
Aug-24-2020
13:45:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN5WRGInitial Entry
5.e
Date Location User Value Reason
Aug-24-2020
13:45:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN5WRHInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-24-2020
13:45:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN5WRHInitial Entry
090177e196ae3070\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-2021-5683-0923309
Page 158 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020
13:43:14
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020
13:43:14
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020
13:43:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-24-2020
13:43:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923310
Page 159 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
review and
correct as
appropriate.
Aug-24-2020
13:43:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-24-2020
13:43:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN5WPXInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-24-2020
13:43:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN5WPXInitial Entry
090177e196ae3070\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-2021-5683-0923311
Page 160 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-24-2020
16:28:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-24-2020
16:28:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-24-2020
16:28:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-24-2020
16:28:49ACV0PFEINFP6000  Data Entry:
Aug/24/2020 13:46Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923312
Page 161 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)
5. Anatomical Location:
Date Location User Value Reason
Aug-24-2020
16:28:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-24-2020
16:28:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-24-2020
16:28:49
(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
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923313
Page 162 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-24-2020
16:28:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECI
FIED OBSERVATION P
ERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-24-2020
16:28:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923314
Page 163 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-24-2020
13:43:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICI
TY E-DIARY NOT CO
LLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923315
Page 164 of 244
***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: 10921048 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-14-2020
11:53:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923316
Page 165 of 244
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Sep-14-2020
12:09:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
2.a
Date Location User Value Reason
Sep-14-2020
12:09:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ident
ifier::1
Temperature
:97.4
Temperature
Unit:F
Temperature
Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-14-2020
12:09:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
090177e196ae3070\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-2021-5683-0923317
Page 166 of 244
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Sep-14-2020
12:09:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-14-2020
12:09:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-14-2020
12:09:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3070\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-2021-5683-0923318
Page 167 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-14-2020
11:56:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-14-2020
11:56:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020
11:56:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-14-2020
11:56:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923319
Page 168 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
review and
correct as
appropriate.
Sep-14-2020
11:56:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-14-2020
11:56:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM9KWRInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-14-2020
11:56:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM9KWRInitial Entry
090177e196ae3070\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-2021-5683-0923320
Page 169 of 244
***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: 10921048 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-14-2020
12:09:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-14-2020
12:09:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-14-2020
12:09:50
(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-14-2020
12:09:50ACV0PFEINFP6000  Data Entry:
Sep/14/2020 11:32Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923321
Page 170 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)
5. Anatomical Location:
Date Location User Value Reason
Sep-14-2020
12:09:50
(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-14-2020
12:09:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-14-2020
12:09:50
(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
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923322
Page 171 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-14-2020
12:09:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECI
FIED OBSERVATION P
ERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-14-2020
12:09:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923323
Page 172 of 244
***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: 10921048 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-12-2020
12:23:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923324
Page 173 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020
12:23:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020
12:23:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020
12:23:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-12-2020
12:23:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923325
Page 174 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
review and
correct as
appropriate.
Oct-12-2020
12:23:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020
12:23:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM9L4HInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020
12:23:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM9L4HInitial Entry
5.b
Date Location User Value Reason
Oct-12-2020
12:24:10
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Sample ID: BL9V75Initial Entry
090177e196ae3070\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-2021-5683-0923326
Page 175 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
5.b Sample ID
Date Location User Value Reason
Oct-12-2020
12:24:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BL9V75Initial Entry
5.c
Date Location User Value Reason
Oct-12-2020
12:24:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9V76Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-12-2020
12:24:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BL9V76Initial Entry
090177e196ae3070\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-2021-5683-0923327
Page 176 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-19-2020
07:24:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Nov-19-2020
07:23:23
(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.
Nov-19-2020
07:23:23
(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
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923328
Page 177 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
missing. Please
review and
update as
appropriate.
Nov-19-2020
07:23:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/16/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-19-2020
07:23:23
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923329
Page 178 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/16/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/15/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Nov-30-2020
14:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Sympt
om Resolved:
Nov/23/2020Transcription
Error
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3070\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-2021-5683-0923330
Page 179 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
4.a
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVE
R
Symptom Pre
sent:YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Nov-19-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3070\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)
FDA-CBER-2021-5683-0923331
Page 180 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)Sympto
ms:NEW OR IN
CREASED
COUGH
Sympto
m Pres
ent:NO
4.b Symptoms:
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASE
D COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symp
toms:NEW OR INC
REASED SH
ORTNESS OF
BREATHInitial Entry
090177e196ae3070\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-2021-5683-0923332
Page 181 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Symp
tom P
resent
:NO
4.c Symptoms:
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASE
D SHORTNESS OF B
REATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHIL
LS
Symptom Pre
sent:NOInitial Entry
090177e196ae3070\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-2021-5683-0923333
Page 182 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.d Symptoms:
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE PA
IN
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3070\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-2021-5683-0923334
Page 183 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.e Symptoms:
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASE
D MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pre
sent:NOInitial Entry
090177e196ae3070\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-2021-5683-0923335
Page 184 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.f Symptoms:
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TAST
E OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THROA
T
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3070\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-2021-5683-0923336
Page 185 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.g Symptoms:
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASE
D SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARR
HEA
Symptom P
resent:NOInitial Entry
090177e196ae3070\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-2021-5683-0923337
Page 186 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.h Symptoms:
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMIT
ING
Symptom P
resent:NOInitial Entry
090177e196ae3070\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-2021-5683-0923338
Page 187 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.i Symptoms:
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-19-2020
07:24:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Nov-19-2020
07:24:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms -
Other:Heada
cheInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Nov-19-2020
07:24:14
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
HeadacheInitial Entry
090177e196ae3070\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-2021-5683-0923339
Page 188 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923340
Page 189 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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
Nov-19-2020
07:24:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-19-2020
07:24:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-19-2020
07:24:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-19-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3070\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)
FDA-CBER-2021-5683-0923341
Page 190 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
07:24:29
(UTC-05:00)
Eastern Time (US
& Canada)Not Done
5. Device Type:
Date Location User Value Reason
Nov-19-2020
07:24:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Nov-19-2020
07:24:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Nov-19-2020
07:24:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
090177e196ae3070\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-2021-5683-0923342
Page 191 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-19-2020
07:24:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Nov-19-2020
07:24:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923343
Page 192 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-19-2020
07:24:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-19-2020
07:24:51
(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
Nov-19-2020
09:01:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-19-2020
07:24:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923344
Page 193 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
review and
correct as
appropriate.
Nov-19-2020
07:24:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/16/2020Initial Entry
5.a
Date Location User Value Reason
Nov-19-2020
09:01:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: CV23469Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-19-2020
09:01:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CV23469Initial Entry
090177e196ae3070\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-2021-5683-0923345
Page 194 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-19-2020
07:25:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-19-2020
07:25:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-19-2020
09:01:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-19-2020
07:25:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Sample
Collected?' is
marked as No
and 'If no
sample was
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923346
Page 195 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
collected or
sample was not
collected
according to
protocol, please
provide reason'
is missing.
Please review
and update as
appropriate.
Nov-19-2020
07:25:00
(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
Nov-19-2020
09:01:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
self swab collectedInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923347
Page 196 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of Pract
itioner:SPEC
IALIS
T
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
090177e196ae3070\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-2021-5683-0923348
Page 197 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of Pra
ctitioner:EMERG
ENCY
ROOM
Occurrence
of Visits or
Contacts:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of P
ractitione
r:PRIMAR
Y CARE
PHYSICI
ANInitial Entry
090177e196ae3070\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-2021-5683-0923349
Page 198 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Occurren
ce of Visit
s or Cont
acts:NO
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PH
YSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of Prac
titioner:URGE
NT CA
RE
Occurrence
of Visits or C
ontacts:NOInitial Entry
090177e196ae3070\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-2021-5683-0923350
Page 199 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-19-2020
07:25:22
(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
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of P
ractitione
r:TELEPH
ONE CO
NSULTA
TION
Occurren
ce of Visit
s or Cont
acts:NOInitial Entry
090177e196ae3070\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-2021-5683-0923351
Page 200 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONS
ULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:OT
HE
R
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae3070\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-2021-5683-0923352
Page 201 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-19-2020
07:25:22
(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
Nov-19-2020
07:25:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3070\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-2021-5683-0923353
Page 202 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/16/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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
Nov-19-2020
07:25:34
(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
Nov-19-2020
07:25:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-19-2020
07:25:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923354
Page 203 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/14/2020Form: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-14-2020
11:48:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/14/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-14-2020
11:48:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923355
Page 204 of 244
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/14/2020Form: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-14-2020
11:48:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-14-2020
11:48:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-14-2020
11:49:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-14-2020
11:48:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923356
Page 205 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/14/2020Form: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
review and
correct as
appropriate.
Dec-14-2020
11:48:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/14/2020Initial Entry
5.a
Date Location User Value Reason
Dec-14-2020
11:49:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNVLJ5Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-14-2020
11:49:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNVLJ5Initial Entry
5.b
Date Location User Value Reason
Dec-14-2020
11:50:09
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Sample ID: BM9LF2Initial Entry
090177e196ae3070\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-2021-5683-0923357
Page 206 of 244
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/14/2020Form: 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
5.b Sample ID
Date Location User Value Reason
Dec-14-2020
11:50:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM9LF2Initial Entry
5.c
Date Location User Value Reason
Dec-14-2020
11:50:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNVLHVInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-14-2020
11:50:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNVLHVInitial Entry
090177e196ae3070\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-2021-5683-0923358
Page 207 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-12-2020
12:25:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-12-2020
12:25:11
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-12-2020
12:25:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923359
Page 208 of 244
***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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Dec-15-2020
09:42:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923360
Page 209 of 244
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Dec-15-2020
09:42:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-15-2020
09:42:25
(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
Dec-15-2020
09:42:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Atrial FibrillationInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-15-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0923361
Page 210 of 244
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
09:42:25
(UTC-05:00)
Eastern Time (US
& Canada)Nov/23/2020 UNK:U
NK
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-08-2021
13:18:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/25/2020 UN
K:UNKNew
Information
Dec-15-2020
09:42:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-15-2020
09:42:25
(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;
090177e196ae3070\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-2021-5683-0923362
Page 211 of 244
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
Jan-08-2021
14:52:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Dec-30-2020
10:58:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answered Medical records
received.
Updated SAE
forms being sent
today
30Dec2020
Dec-17-2020
16:36:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Reissued:O
penedCLINICAL
Thank you;
please submit
Covid lab test in
Hospital
information
(Yes/No; if yes
then date &
time) when
medical records
are available
Dec-17-2020
11:59:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answered Medical records
pending
Dec-17-2020 ACV0PFEINFP6000  auto query Query 1: Deleted Close Auto
090177e196ae3070\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-2021-5683-0923363
Page 212 of 244
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
06:49:51
(UTC-05:00)
Eastern Time (US
& Canada)(autoquery) Query
Dec-16-2020
20:25:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opened Clinical COVID
test status
(yes/no) during
Hosp was not
reported in the
SAE. Please
submit a
follow-up SAE
form
[#2020496910]
to document if
COVID testing
was performed
(YES/NO or info
not available)
and if yes, the
date and results.
Dec-15-2020
09:42:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Atrial
Fibrillation:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Dec-15-2020
09:42:25
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
YES
Is this serious evenInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923364
Page 213 of 244
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)t associated with c
ongenital anomaly
or birth defect?
NO
Did this serious ev
ent result in death?
NO
Did this serious ev
ent require or prolo
ng hospitalization?
YES
Did this serious ev
ent result in persist
ent or significant di
sability/incapacity?
NO
Is this serious even
t life threatening?
NO
Other medically im
portant serious eve
nt
NO
8. Is this adverse event the result of a study Medication Error?
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923365
Page 214 of 244
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-15-2020
09:42:25
(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
Dec-15-2020
09:42:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this ev
ent is due to:
OTHER
If Other, specify:
Cardiac medical
historyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-15-2020
09:42:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3070\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-2021-5683-0923366
Page 215 of 244
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-15-2020
09:42:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-15-2020
09:42:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Jan-12-2021
20:41:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Clo
sedResponse satisfies query
Jan-08-2021
13:18:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
4: Clo
sedClose Auto Query
090177e196ae3070\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-2021-5683-0923367
Page 216 of 244
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Jan-08-2021
13:18:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
3: An
swere
dNew Information
Jan-08-2021
13:18:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
REC
OVE
RED/
RESO
LVE
DNew Information
Jan-08-2021
13:18:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
4: Op
enedFor AE Atrial Fibrillation: Response
to "What was the outcome of this
adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Jan-05-2021
07:48:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Op
enedSAE
RECON:AER#2020496910,outcome
was reported as UNKNOWN to
Safety DB however, recorded as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Dec-21-2020
00:13:00
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies query
090177e196ae3070\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-2021-5683-0923368
Page 217 of 244
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US &
Canada)
Dec-18-2020
13:21:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: An
swere
dAnswer Auto Query
Dec-18-2020
13:21:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
REC
OVE
RING
/RES
OLVI
NGSince subject is out of hospital,
changed SAE form to reflect
recovering from SAE and will send
form today (18Dec2020)
Dec-18-2020
07:23:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Dec-18-2020
01:31:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Rei
ssued:
Open
edDM: Thank you for response. Once
outcome data is received, please
review and update response to field
‘What was the outcome of this
adverse event’. Else update response
to 'Is the adverse event still ongoing'
as appropriate.
Dec-17-2020
12:01:31
(UTC-05:00)ACV0PFEINFP6000  Query
2: An
swereOutcome will be determined when
medical records are received
090177e196ae3070\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-2021-5683-0923369
Page 218 of 244
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time
(US &
Canada)d
Dec-17-2020
12:00:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Op
enedFor AE Atrial Fibrillation: 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".
Dec-17-2020
12:00:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription Error
Dec-17-2020
12:00:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
UNK
NOW
NTranscription Error
Dec-17-2020
06:51:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Op
enedSAE
RECON:AER#2020496910,outcome
was reported as UNKNOWN to
Safety DB however, recorded as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Dec-15-2020
09:42:25
(UTC-05:00)ACV0PFEINFP6000  Data
Entry
:Initial Entry
090177e196ae3070\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-2021-5683-0923370
Page 219 of 244
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time
(US &
Canada)REC
OVE
RING
/RES
OLVI
NG
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-15-2020
09:42:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-17-2020
06:49:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
2020496910Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0923371
Page 220 of 244
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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-29-2021
16:17:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/28/2021Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923372
Page 221 of 244
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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
Jan-29-2021
16:17:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing t
o return for Vaccinatio
n 3
Participant is:
eligible per other pr
otocol allowance(s)
and confirmed to ha
ve received only pl
acebo at Vaccinatio
n 1/2Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923373
Page 222 of 244
***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: 10921048 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-29-2021
16:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/28/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-29-2021
16:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923374
Page 223 of 244
***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: 10921048 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-29-2021
16:16:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923375
Page 224 of 244
***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: 10921048 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-29-2021
16:17:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923376
Page 225 of 244
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 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: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-11-2021
14:32:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Clo
sedResponse satisfies query
Feb-11-2021
06:51:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: An
sweredAdded
Feb-11-2021
03:44:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Op
enedDM: Please consider
updating
INCLUSION/EXCLUSION
CRITERIA - FURTHER
VACCINATION form as
Not Applicable by selecting
form level comment. Thank
you.
Feb-10-2021
11:51:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021Initial Entry
090177e196ae3070\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-2021-5683-0923377
Page 226 of 244
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-10-2021
11:51:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consen
t Obtained
Feb/10/2021Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923378
Page 227 of 244
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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
Feb-10-2021
11:51:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-10-2021
11:51:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-10-2021
11:51:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0923379
Page 228 of 244
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-10-2021
11:52:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-10-2021
11:52:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021
14:41:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-10-2021
11:52:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923380
Page 229 of 244
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
review and
correct as
appropriate.
Feb-10-2021
11:52:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/10/2021Initial Entry
5.a
Date Location User Value Reason
Feb-10-2021
14:41:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSM61JInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-10-2021
14:41:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSM61JInitial Entry
5.b
Date Location User Value Reason
Feb-10-2021
14:41:44
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Sample ID: BR969GInitial Entry
090177e196ae3070\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-2021-5683-0923381
Page 230 of 244
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
5.b Sample ID
Date Location User Value Reason
Feb-10-2021
14:41:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR969GInitial Entry
5.c
Date Location User Value Reason
Feb-10-2021
14:41:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSM61CInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-10-2021
14:41:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSM61CInitial Entry
090177e196ae3070\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-2021-5683-0923382
Page 231 of 244
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-10-2021
11:52:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-10-2021
11:52:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021
14:31:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-10-2021
11:52:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0923383
Page 232 of 244
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
review and
correct as
appropriate.
Feb-10-2021
11:52:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/10/2021Initial Entry
5.a
Date Location User Value Reason
Feb-10-2021
14:31:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR9696Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-10-2021
14:31:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR9696Initial Entry
090177e196ae3070\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-2021-5683-0923384
Page 233 of 244
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 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
Feb-10-2021
11:52:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-10-2021
11:52:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-10-2021
11:52:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-10-2021
11:52:27ACV0PFEINFP6000  Data Entry:
Feb/10/2021 10:41Initial Entry
090177e196ae3070\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0923385
Page 234 of 244
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd.
Subject No: 10921048 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)
5. Anatomical Location:
Date Location User Value Reason
Feb-10-2021
1
…[truncated]