125742 S1 M5 CRF c4591001 1077 10771049

Document text

Page 1 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953258
Page 2 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/17/2020
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953259
Page 3 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10771049]
2.Birth Date: /1958
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:
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953260
Page 4 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953261
Page 5 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953262
Page 6 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953263
Page 7 of 153
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[APPENDICITIS]
Start Date: UNK/UNK/1965
Ongoing: NO
End Date:
UNK/UNK/1965
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CHRONIC SINUS INFECTIONS]
Start Date: UNK/UNK/1960
Ongoing: NO
End Date:
UNK/UNK/1960
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TRANSIENT ISCHEMIC ATTACK]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ASTHMA]
Start Date: UNK/UNK/2006
Ongoing: YES
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953264
Page 8 of 153
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/2005
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BELL'S PALSY, RIGHT SIDE]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953265
Page 9 of 153
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Aug/17/2020
2.Weight: [100.1]
3.Unit: kg
4.Height: [174.0]
5.Unit: cm
6.Body Mass Index: [33.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953266
Page 10 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/17/2020
2.Randomization Number: [230502]
3.Randomization Group: [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953267
Page 11 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
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 [BP1H5R]
5.bSample ID [BP1H5S]
5.cSample ID [BP1H5T]
5.dSample ID [BPRMJL]
5.eSample ID [BPRMJM]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953268
Page 12 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
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 [BP1H56]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953269
Page 13 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/17/2020 12:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953270
Page 14 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953271
Page 15 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953272
Page 16 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953273
Page 17 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
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 [BP8HP5]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953274
Page 18 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/8/2020 11:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953275
Page 19 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953276
Page 20 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1HN0]
5.bSample ID [BP1HN1]
5.cSample ID [BP1HN2]
5.dSample ID [BMNNNS]
5.eSample ID [BMNNNT]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953277
Page 21 of 153
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953278
Page 22 of 153
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
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 [BR9RPY]
5.bSample ID [BS0849]
5.cSample ID [BS084B]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953279
Page 23 of 153
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953280
Page 24 of 153
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953281
Page 25 of 153
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953282
Page 26 of 153
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953283
Page 27 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953284
Page 28 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953285
Page 29 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953286
Page 30 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953287
Page 31 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953288
Page 32 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953289
Page 33 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953290
Page 34 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953291
Page 35 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953292
Page 36 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953293
Page 37 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953294
Page 38 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953295
Page 39 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953296
Page 40 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953297
Page 41 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  BELL'S PALSY, RIGH
T SIDE Oct/25/2020 UNK
:UNK NO
End Date Time:
Nov/23/2020 UNK:UN
K
 Repeating
Pages
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953298
Page 42 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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)[BELL'S PALSY, RIGHT SIDE]
4.Start Date Time: Oct/25/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/23/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[REOCCURENCE OF PAST CONDITION]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953299
Page 43 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953300
Page 44 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953301
Page 45 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953302
Page 46 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medicat
ionStart Da
teForm Instanc
e
 1.1  VACCINATIONS  NO  INFLUENZA VA
CCINE Sep/11/2
020 Repeating
Pages
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953303
Page 47 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[INFLUENZA VACCINE]
5.Date: Sep/11/2020
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953304
Page 48 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1. DELETED 1  CORTICOSTE
ROIDS NO  PREDNISO
NE 60  Repeating
Pages
 2. DELETED 2  CORTICOSTE
ROIDS NO  PREDNISO
NE 40  Repeating
Pages
 3. DELETED 3  CORTICOSTE
ROIDS NO  PREDNISO
NE 20  Repeating
Pages
 4. DELETED 4  CORTICOSTE
ROIDS NO  PREDNISO
NE 10  Repeating
Pages
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953305
Page 49 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
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).[PREDNISONE ]
5.Dose: [60]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: Oct/25/2020
10.Ongoing? NO
End Date:
Oct/29/2020
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953306
Page 50 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
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).[PREDNISONE ]
5.Dose: [40]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: Oct/30/2020
10.Ongoing? NO
End Date:
Oct/31/2020
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953307
Page 51 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [3]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
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).[PREDNISONE ]
5.Dose: [20]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: Nov/1/2020
10.Ongoing? NO
End Date:
Nov/2/2020
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953308
Page 52 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [4]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
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).[PREDNISONE ]
5.Dose: [10]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: Nov/3/2020
10.Ongoing? NO
End Date:
Nov/4/2020
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953309
Page 53 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953310
Page 54 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953311
Page 55 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953312
Page 56 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953313
Page 57 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953314
Page 58 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953315
Page 59 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953316
Page 60 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953317
Page 61 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953318
Page 62 of 153
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953319
Page 63 of 153
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953320
Page 64 of 153
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953321
Page 65 of 153
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953322
Page 66 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953323
Page 67 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953324
Page 68 of 153
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/18/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953325
Page 69 of 153
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953326
Page 70 of 153
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953327
Page 71 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/6/2020
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953328
Page 72 of 153
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953329
Page 73 of 153
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Suchet Patel  Approved Mar-12-2021 14:48:37 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SuchetPatel, 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.
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953330
Page 74 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormAug-17-2020 18:10:58 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953331
Page 75 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Suchet Patel  Approved Mar-12-2021 14:48:37 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SuchetPatel, 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 Feb-11-2021 08:56:19 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Suchet Patel  Approved Jan-27-2021 17:27:05 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SuchetPatel, 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-27-2021 13:49:56 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953332
Page 76 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Suchet Patel  Approved Jan-27-2021 08:49:06 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SuchetPatel, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-04-2020 09:07:35 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Suchet Patel  Approved Dec-02-2020 09:00:03 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SuchetPatel, 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-23-2020 16:25:28 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Suchet Patel  Approved Nov-20-2020 16:38:52 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953333
Page 77 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Affidavit:
By my dated signature below, I, SuchetPatel, 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-20-2020 14:55:48 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Suchet Patel  Approved Nov-16-2020 16:26:13 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SuchetPatel, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-16-2020 14:07:17 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Suchet Patel  Approved Oct-22-2020 16:33:08 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SuchetPatel, 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.
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953334
Page 78 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-17-2020 18:10:15
(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-17-2020 18:10:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953335
Page 79 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-17-2020 18:10:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/17/2020Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953336
Page 80 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-17-2020 18:09:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10771049Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-17-2020 18:09:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1958Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-17-2020 18:10:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-17-2020 18:10:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-17-2020 18:10:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953337
Page 81 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-17-2020 18:10:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953338
Page 82 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-17-2020 18:11:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-17-2020 18:11:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-17-2020 18:11:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953339
Page 83 of 153
***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, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Aug-17-2020 18:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:APPENDICITI
S
Start Date: UNK/UNK/196
5
Ongoing: NO
End Date:
UNK/UNK/
1965Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-17-2020 18:11:46
(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-17-2020 18:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
APPENDICITISInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-17-2020 18:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1965Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953340
Page 84 of 153
***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, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-17-2020 18:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1965Initial Entry
1.b
Date Location User Value Reason
Aug-17-2020 18:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:CHRONIC SINUS I
NFECTIONS
Start Date: UNK/UNK/1960
Ongoing: NO
End Date:
UNK/UNK/1960Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953341
Page 85 of 153
***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, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b Line/MH Number:
Date Location User Value Reason
Aug-17-2020 18:12:13
(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-17-2020 18:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHRONIC SINUS INFECTION
SInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-17-2020 18:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1960Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-17-2020 18:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1960Initial Entry
1.c
Date Location User Value Reason
Aug-17-2020 18:14:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:TRANSIENT ISCH
EMIC ATTACK
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953342
Page 86 of 153
***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, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.c Line/MH Number:
Date Location User Value Reason
Aug-17-2020 18:14:08
(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-17-2020 18:14:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TRANSIENT ISCHEMIC ATTA
CKInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-17-2020 18:14:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-17-2020 18:14:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.d
Date Location User Value Reason
Aug-17-2020 18:15:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History T
erm:ASTHMA
Start Date: UNK/UNK/2
006
Ongoing: YESInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953343
Page 87 of 153
***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, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.d Line/MH Number:
Date Location User Value Reason
Aug-17-2020 18:15:41
(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-18-2020 14:59:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Aug-18-2020 14:50:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Condition is stable,
no change in
treatment and no
hospitalizations
within 6 weeks.
Subject on stable
medication.
Aug-18-2020 12:29:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened GPD Clin: Per IC3,
please confirm
stability of
symptoms prior to
study enrolment; that
no significant
change in therapy or
hospitalization for
worsening of disease
within 6 weeks of
enrolment. Also,
confirm EC13
reviewed (systemic
corticosteroid use)
Aug-17-2020 18:15:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASTHMAInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-17-2020 18:15:41
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
UNK/UNK/2006Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0953344
Page 88 of 153
***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, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
1.d Ongoing:
Date Location User Value Reason
Aug-17-2020 18:15:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-17-2020 18:15:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:HYPERTENS
ION
Start Date: UNK/UNK/20
05
Ongoing: YESInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953345
Page 89 of 153
***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, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.e Line/MH Number:
Date Location User Value Reason
Aug-17-2020 18:15:59
(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-17-2020 18:15:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERTENSIONInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-17-2020 18:15:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-17-2020 18:15:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Dec-04-2020 17:16:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH N
umber:6
Medical His
tory Term:BELL'S PALSY,
RIGHT SIDE
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/20
13New Information
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953346
Page 90 of 153
***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, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Nov-20-2020 14:55:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:BELL'S PALS
Y
Start Date: UNK/UNK/20
13
Ongoing: NO
End Date:
UNK/UNK
/2013Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953347
Page 91 of 153
***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, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.f Line/MH Number:
Date Location User Value Reason
Nov-20-2020 14:55:48
(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
Dec-04-2020 17:16:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BELL'S PALSY, RIGHT SIDENew Information
Nov-20-2020 14:55:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BELL'S PALSYInitial Entry
1.f Start Date:
Date Location User Value Reason
Nov-20-2020 14:55:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.f Ongoing:
Date Location User Value Reason
Nov-20-2020 14:55:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953348
Page 92 of 153
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Aug-17-2020 18:14:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-17-2020 18:14:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
100.1Initial Entry
3. Unit:
Date Location User Value Reason
Aug-17-2020 18:14:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-17-2020 18:14:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
174.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-17-2020 18:14:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-17-2020 18:14:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
33.1Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953349
Page 93 of 153
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7.a
Date Location User Value Reason
Aug-17-2020 18:14:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 98.2
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-17-2020 18:14:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-17-2020 18:14:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-17-2020 18:14:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-17-2020 18:14:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953350
Page 94 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-17-2020 18:15:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-17-2020 18:15:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
230502Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953351
Page 95 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020 18:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020 18:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020 18:16:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-17-2020 18:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-17-2020 18:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020 18:16:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1H5RInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953352
Page 96 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Aug-17-2020 18:16:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1H5RInitial Entry
5.b
Date Location User Value Reason
Aug-17-2020 18:16:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1H5SInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-17-2020 18:16:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1H5SInitial Entry
5.c
Date Location User Value Reason
Aug-17-2020 18:16:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1H5TInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-17-2020 18:16:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1H5TInitial Entry
5.d
Date Location User Value Reason
Aug-17-2020 18:17:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRMJLInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953353
Page 97 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.d Sample ID
Date Location User Value Reason
Aug-17-2020 18:17:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRMJLInitial Entry
5.e
Date Location User Value Reason
Aug-17-2020 18:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRMJMInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-17-2020 18:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRMJMInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953354
Page 98 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020 18:17:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020 18:17:31
(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-17-2020 18:17:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-17-2020 18:17:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-17-2020 18:17:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020 18:17:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1H56Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953355
Page 99 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Aug-17-2020 18:17:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1H56Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953356
Page 100 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-17-2020 18:18:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-17-2020 18:18:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-17-2020 18:18:33
(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-17-2020 18:18:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020 12:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-17-2020 18:18:33
(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-17-2020 18:18:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953357
Page 101 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Aug-17-2020 18:18:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-17-2020 18:18:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-17-2020 18:18:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953358
Page 102 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-19-2020 16:02:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTNew Information
Aug-17-2020 18:18:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-
DIARY COLLECTED FOR TH
IS SUBJECTInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953359
Page 103 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020 12:38:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953360
Page 104 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020 12:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2.a
Date Location User Value Reason
Sep-08-2020 12:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 98.5
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-08-2020 12:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-08-2020 12:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-08-2020 12:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953361
Page 105 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.a Temperature Location:
Date Location User Value Reason
Sep-08-2020 12:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953362
Page 106 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 13:32:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 13:32:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020 13:33:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-08-2020 13:32:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-08-2020 13:32:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020 13:33:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8HP5Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953363
Page 107 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Sep-08-2020 13:33:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8HP5Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953364
Page 108 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-08-2020 12:39:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020 12:39:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020 12:39:52
(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-08-2020 12:39:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020 11:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020 12:39:52
(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-08-2020 12:39:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953365
Page 109 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Sep-08-2020 12:39:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-08-2020 12:39:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-08-2020 12:39:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953366
Page 110 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020 13:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953367
Page 111 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 14:14:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 14:14:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020 14:14:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-06-2020 14:14:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-06-2020 14:14:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020 14:14:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1HN0Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953368
Page 112 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Oct-06-2020 14:14:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1HN0Initial Entry
5.b
Date Location User Value Reason
Oct-06-2020 14:15:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1HN1Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-06-2020 14:15:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1HN1Initial Entry
5.c
Date Location User Value Reason
Oct-06-2020 14:15:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1HN2Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-06-2020 14:15:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1HN2Initial Entry
5.d
Date Location User Value Reason
Oct-06-2020 14:15:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNNNSInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953369
Page 113 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.d Sample ID
Date Location User Value Reason
Oct-06-2020 14:15:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMNNNSInitial Entry
5.e
Date Location User Value Reason
Oct-06-2020 14:15:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNNNTInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-06-2020 14:15:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMNNNTInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953370
Page 114 of 153
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021 13:36:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/2/2021Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0953371
Page 115 of 153
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-02-2021 15:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-02-2021 15:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-02-2021 15:07:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-02-2021 15:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-02-2021 15:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/2/2021Initial Entry
5.a
Date Location User Value Reason
Mar-02-2021 15:07:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR9RPYInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953372
Page 116 of 153
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Mar-02-2021 15:07:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR9RPYInitial Entry
5.b
Date Location User Value Reason
Mar-02-2021 15:07:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS0849Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-02-2021 15:07:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS0849Initial Entry
5.c
Date Location User Value Reason
Mar-02-2021 15:07:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS084BInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-02-2021 15:07:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS084BInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953373
Page 117 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-14-2020 09:27:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-13-2020 08:36:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-13-2020 08:36:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Transcription Error
Oct-13-2020 06:55:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: As per CRF
guidelines, the
treatment period is
defined as 1st
vaccination visit
through the 1-month
post vaccination
visit after the 2nd
vaccination. Please
update date of EOT
to match the date
the Visit 3(1 month)
visit was completed.
Oct-07-2020 10:06:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-07-2020 10:06:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953374
Page 118 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-07-2020 10:06:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953375
Page 119 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Nov-16-2020 14:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953376
Page 120 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020 14:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020 14:07:17
(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-07-2020
09:05:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
ClosedResponse
satisfies query
Dec-07-2020
08:14:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
AnsweredAdded Right
Side to both AE
and MH. We are
awaiting records
as this subject is
not in house
patient.
Dec-06-2020
11:48:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
Reissued:
Openedclin: do not see
'new
information' Pls
confirm no
acyclovir given
and advise on
indication for
clindamycin ie
was there
concern for
bacterial
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953377
Page 121 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
superinfection?
Pls also advise if
Lyme titres were
sent.
Dec-06-2020
11:46:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 3:
ClosedResponse
satisfies query
Dec-04-2020
17:16:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3:
AnsweredNew
Information
Dec-04-2020
17:16:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2:
AnsweredNew
Information
Dec-04-2020
17:16:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Ent
ry:
BELL'S P
ALSY, RI
GHT SID
ENew
Information
Dec-04-2020
12:20:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 3:
Reissued:
Openedclin: Thank you
very much. Pls
update logAE
and MedHx
CRF with
additional
information on
laterality. Have
requested DM
unlock/unfreeze
CRF for you.
Dec-04-2020
11:23:50
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Query 3:
AnsweredRight side for
both episodes.
Resolved both
times without
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0953378
Page 122 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(US &
Canada)sequelae. Total
daily dose 10
mg.
Dec-04-2020
09:56:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 3:
Openedclin: pls advise
what side
previous Bell's
and current
Bells' occurred
and if prior
episode of Bell's
resolved w or
w/o sequelae.
Confirm total
daily dose or
prednisone was
10mg. Thanks
Dec-04-2020
09:26:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
Reissued:
Openedclin: Thank you.
Pls confirm no
acyclovir given
and advise on
indication for
clindamycin ie
was there
concern for
bacterial
superinfection?
Pls also advise if
Lyme titres were
sent.
Dec-04-2020
09:08:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
AnsweredSubject took
Prednisone,
which has been
added to
prohibited CM.
Also took
clindamycin. No
sequelae,
resolved.
Dec-04-2020
08:52:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
Openedclin: pls advise
which, if any,
medications
used for
treatment and if
subject has any
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953379
Page 123 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
residual
sequelae. Thank
you.
Nov-25-2020
05:39:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
ClosedResponse
satisfies query
Nov-24-2020
08:13:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
AnsweredBell's palsy is a
recurrent
condition that
can reoccur or
not.
Nov-24-2020
03:17:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1:
OpenedThe AE BELL S
PALSY was
reported but is
also listed in
Medical History.
Please clarify if
this is a
worsening of the
baseline
condition, and if
so, please
consider adding
"worsening" to
the AE term. AE
as baseline
conditions
should only be
reported as AEs
if they worsen.
Nov-16-2020
14:07:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Ent
ry:
BELL'S P
ALSYInitial Entry
4. Start Date Time:
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953380
Page 124 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Nov-16-2020 14:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/25/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-23-2020 16:25:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/23/2020 UNK:UNKNew Information
Nov-23-2020 11:36:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Juleen Gayed Query 1: Closed Response satisfies
query
Nov-20-2020 14:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Ongoing as of
20Nov2020.
Nov-20-2020 12:21:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Juleen Gayed Query 1: Opened Clin: Please confirm
if this AE is still
ongoing
Nov-16-2020 14:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020 14:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0953381
Page 125 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Nov-16-2020 14:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-16-2020 14:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-23-2020 05:22:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Nov-19-2020 11:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Please unlock
Medical History
page for entry.
Nov-19-2020 10:41:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY: Past
condition is noted
for Bell's Palsy but
no MH entry is
recorded at V1.
Please review and
clarify if update is
required.
Nov-16-2020 14:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
REOCCURENCE OF PA
ST CONDITIONInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0953382
Page 126 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Nov-16-2020 14:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-16-2020 14:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-16-2020 14:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-23-2020 16:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-23-2020 16:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-23-2020 16:25:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE BELL'S
PALSY: Response to
"What was the
outcome of this
adverse event?" is
'Not Recovered/Not
Resolved' but AE
End Date/Time is
present.
Nov-16-2020 14:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953383
Page 127 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Nov-16-2020 14:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953384
Page 128 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Oct-06-2020 13:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953385
Page 129 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-06-2020 13:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Oct-06-2020 13:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-06-2020 13:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Oct-06-2020 13:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
INFLUENZA VACCINEInitial Entry
5. Date:
Date Location User Value Reason
Oct-06-2020 13:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953386
Page 130 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Feb-15-2021 16:24:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted New
Information
Dec-04-2020 09:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953387
Page 131 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Feb-11-2021 08:56:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted New
Information
Jan-27-2021 13:51:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953388
Page 132 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Feb-11-2021 08:57:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted New
Information
Jan-27-2021 13:52:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953389
Page 133 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Feb-11-2021 08:57:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted New
Information
Jan-27-2021 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953390
Page 134 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Dec-04-2020 09:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Dec-04-2020 09:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CORTICOSTEROIDSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Dec-04-2020 09:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Feb-17-2021 09:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-15-2021 16:24:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Feb-15-2021 13:17:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLINQUERY:
THANK YOU for
updating data
entered in error on
lines 2-4. Please
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0953391
Page 135 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
verify that this initial
entry was also
entered in error and
update CRF
accordingly
Feb-03-2021 16:28:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Do you want these
deleted? If so, the
lines 2-4 need to be
unfrozen.
Feb-03-2021 14:57:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLINQUERY:
Query response
notes data was
entered in error, but
data remains in
system. If confirmed
entered in error,
please update CRF
accordingly.
Jan-29-2021 19:55:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Entered in error.
Jan-29-2021 11:03:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLINQUERY:
Thank you for
updating the
prednisone dosing
data. However,
prednisone is still
only reported over
11 days, which is not
prohibited per
protocol. Please
clarify if entries
were entered in error.
Jan-27-2021 14:00:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered UPDATED
INFORMATION
ADDED TO
CONMED LOG TO
REFLECT
ANSWER ON
22JAN2021.
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953392
Page 136 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-27-2021 11:01:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLINQUERY:
Thank you for your
query response.
However, if steroid
treatment was not
longer than 14 days
AND greater than 20
mg daily, it is not
consisered a
prohibited med. As
this treatment was
less than 14 days,
please verify it was
entered in error.
Jan-22-2021 20:12:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Prednisone was
taken less than 14
days (for Bell's Palsy
AE); however daily
dose did exceed
20mg equivalent x 5
days. Tapered dose
schedule: Day 1-5
was 60mg QD. Day
6-7 was 40mg QD.
Day 8-9 was 20mg.
Day 10-11 was 10mg
QD.
Jan-22-2021 15:35:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Prednisone is
reported from
25OCT20 to
06NOV20. As this
corticosteroid was
not taken for 14
days, please verify it
is not a prohibited
medication per
section 6.5.1 of the
protocol. Therefore,
please verify it was
entered in error.
Jan-22-2021 10:21:34 ACV0PFEINFP6000  Query 1: Candidate CLINQUERY:
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0953393
Page 137 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-05:00) Eastern
Time (US & Canada)Prednisone is
reported from
25OCT20 to
06NOV20. As this
corticosteroid was
not taken for 14
days, please verify it
is not a prohibited
medication per
section 6.5.1 of the
protocol. Therefore,
please verify it was
entered in error.
Dec-04-2020 09:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PREDNISONEInitial Entry
5. Dose:
Date Location User Value Reason
Jan-27-2021 13:49:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
60Transcription Error
Dec-04-2020 09:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
10Initial Entry
6. Dose Unit:
Date Location User Value Reason
Dec-04-2020 09:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Dec-04-2020 09:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
QDInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953394
Page 138 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
8. Route:
Date Location User Value Reason
Dec-04-2020 09:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORALInitial Entry
9. Start Date:
Date Location User Value Reason
Dec-04-2020 09:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/25/2020Initial Entry
10. Ongoing?
Date Location User Value Reason
Jan-27-2021 13:50:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Oct/29/2020New Information
Dec-04-2020 09:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Nov/6/2020Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953395
Page 139 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Jan-27-2021 13:51:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
2. Category:
Date Location User Value Reason
Jan-27-2021 13:51:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CORTICOSTEROIDSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Jan-27-2021 13:51:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Feb-12-2021 18:06:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-11-2021 08:56:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Feb-11-2021 01:34:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Query response on
first prednisone
entry confirms data
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0953396
Page 140 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
was entered in error.
Please verify and
update CRF
accordingly.
Feb-10-2021 14:02:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Candidate CLINQUERY:
Query response on
first prednisone
entry confirms data
was entered in error.
Please verify and
update CRF
accordingly.
Jan-27-2021 13:51:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PREDNISONEInitial Entry
5. Dose:
Date Location User Value Reason
Jan-27-2021 13:51:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
40Initial Entry
6. Dose Unit:
Date Location User Value Reason
Jan-27-2021 13:51:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Jan-27-2021 13:51:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
QDInitial Entry
8. Route:
Date Location User Value Reason
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953397
Page 141 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-27-2021 13:51:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORALInitial Entry
9. Start Date:
Date Location User Value Reason
Jan-27-2021 13:51:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
10. Ongoing?
Date Location User Value Reason
Jan-27-2021 13:51:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Oct/31/2020Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953398
Page 142 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Jan-27-2021 13:52:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
2. Category:
Date Location User Value Reason
Jan-27-2021 13:52:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CORTICOSTEROIDSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Jan-27-2021 13:52:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Feb-12-2021 18:06:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-11-2021 08:57:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Feb-11-2021 01:35:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Query response on
first prednisone
entry confirms data
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0953399
Page 143 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
was entered in error.
Please verify and
update CRF
accordingly.
Feb-10-2021 14:02:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Candidate CLINQUERY:
Query response on
first prednisone
entry confirms data
was entered in error.
Please verify and
update CRF
accordingly.
Jan-27-2021 13:52:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PREDNISONEInitial Entry
5. Dose:
Date Location User Value Reason
Jan-27-2021 13:52:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
20Initial Entry
6. Dose Unit:
Date Location User Value Reason
Jan-27-2021 13:52:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Jan-27-2021 13:52:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
QDInitial Entry
8. Route:
Date Location User Value Reason
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953400
Page 144 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-27-2021 13:52:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORALInitial Entry
9. Start Date:
Date Location User Value Reason
Jan-27-2021 13:52:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/1/2020Initial Entry
10. Ongoing?
Date Location User Value Reason
Jan-27-2021 13:52:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Nov/2/2020Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953401
Page 145 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Jan-27-2021 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
2. Category:
Date Location User Value Reason
Jan-27-2021 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CORTICOSTEROIDSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Jan-27-2021 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Feb-12-2021 18:06:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-11-2021 08:57:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Feb-11-2021 01:35:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Query response on
first prednisone
entry confirms data
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0953402
Page 146 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
was entered in error.
Please verify and
update CRF
accordingly.
Feb-10-2021 14:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Candidate CLINQUERY:
Query response on
first prednisone
entry confirms data
was entered in error.
Please verify and
update CRF
accordingly.
Jan-27-2021 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PREDNISONEInitial Entry
5. Dose:
Date Location User Value Reason
Jan-27-2021 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
10Initial Entry
6. Dose Unit:
Date Location User Value Reason
Jan-27-2021 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Jan-27-2021 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
QDInitial Entry
8. Route:
Date Location User Value Reason
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953403
Page 147 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-27-2021 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORALInitial Entry
9. Start Date:
Date Location User Value Reason
Jan-27-2021 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/3/2020Initial Entry
10. Ongoing?
Date Location User Value Reason
Jan-27-2021 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Nov/4/2020Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953404
Page 148 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-15-2021 12:12:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953405
Page 149 of 153
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-22-2021 19:19:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Transcription Error
Feb-15-2021 12:12:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is NOT willing to ret
urn for Vaccination 3 OR otherw
ise not eligibleInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0953406
Page 150 of 153
***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, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-18-2021 16:01:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Feb-23-2021
03:03:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies
query
Feb-22-2021
19:19:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dFurther Vaccination
Confirmation CRF
updated
Feb-22-2021
01:56:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7348610;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Feb-18-2021
16:01:36
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000  Data
Entry
:
ASSE
SS ELInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953407
Page 151 of 153
***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, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Canada) IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ON
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953408
Page 152 of 153
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-07-2020 10:06:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-17-2020 18:15:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-17-2020 18:11:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-13-2020 08:36:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/6/2020Transcription Error
Oct-07-2020 10:06:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
Aug-17-2020 18:15:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/17/2020Initial Entry
Aug-17-2020 18:11:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/17/2020Initial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953409
Page 153 of 153
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771049 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020 15:54:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae30d1\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953410