Document text
Page 1 of 269
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 14-Jan-2021 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 version01 DEC 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495793
Page 2 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/8/2021
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495794
Page 3 of 269
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 14-Jan-2021 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Demography
1.Subject ID [11391246]
2.Birth Date: /2005
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:
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2022-5812-0495795
Page 4 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495796
Page 5 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495797
Page 6 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathJan/8/2021
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495798
Page 7 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Acne]
Start Date: Jun/30/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[dyslexia]
Start Date: UNK/UNK/2005
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[sleep disturbance]
Start Date: Jun/30/2015
Ongoing: YES
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495799
Page 8 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[intermittent muscle strain]
Start Date: Jun/30/2018
Ongoing: YES
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495800
Page 9 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495801
Page 10 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 14-Jan-2021 02:19 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/8/2021
2.Weight: [158.0]
3.Unit: LB
4.Height: [70.5]
5.Unit: in
6.Body Mass Index: [22.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495802
Page 11 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Jan/8/2021
2.Randomization Number: [26319]
3.Randomization Group: [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495803
Page 12 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/8/2021
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 [BP8N55]
5.bSample ID [BP8N56]
5.cSample ID [BP8N57]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495804
Page 13 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/8/2021
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 [BP8N5F]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495805
Page 14 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: Jan/8/2021 16:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495806
Page 15 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495807
Page 16 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495808
Page 17 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495809
Page 18 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?YES
Ongoing?
NO
Stop Date:
Jan/15/2021
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495810
Page 19 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?YES
Ongoing?
NO
Stop Date:
Jan/15/2021
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495811
Page 20 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/29/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495812
Page 21 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/29/2021
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 [BR5RCK]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495813
Page 22 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: Jan/29/2021 13:53
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495814
Page 23 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495815
Page 24 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495816
Page 25 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495817
Page 26 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495818
Page 27 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
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 [BNWY4P]
5.bSample ID [BRMJV2]
5.cSample ID [BRMJV3]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495819
Page 28 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495820
Page 29 of 269
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495821
Page 30 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495822
Page 31 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495823
Page 32 of 269
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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?
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495824
Page 33 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495825
Page 34 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495826
Page 35 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495827
Page 36 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495828
Page 37 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495829
Page 38 of 269
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495830
Page 39 of 269
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Unplanned Assessments
1.Assessments
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495831
Page 40 of 269
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495832
Page 41 of 269
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 30-Apr-2021 01:41 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495833
Page 42 of 269
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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?
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495834
Page 43 of 269
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495835
Page 44 of 269
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495836
Page 45 of 269
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495837
Page 46 of 269
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/29/2021
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495838
Page 47 of 269
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/29/2021
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 [BR5RD8]
5.bSample ID [BR5RD6]
5.cSample ID [BR5RD7]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495839
Page 48 of 269
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/29/2021
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 [BR5RCM]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495840
Page 49 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/12/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495841
Page 50 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/12/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
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 [AA09865]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495842
Page 51 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/26/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK4
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495843
Page 52 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/26/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
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 [BRMJTZ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495844
Page 53 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/12/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK6
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495845
Page 54 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/12/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Mar/12/2021
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 [AA09866]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495846
Page 55 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 4 -
Unscheduled Visit on Mar/26/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/26/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK8
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495847
Page 56 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 4 -
Unscheduled Visit on Mar/26/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Mar/26/2021
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 [AA09886]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495848
Page 57 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 5 -
Unscheduled Visit on Apr/09/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/9/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK10
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495849
Page 58 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 5 -
Unscheduled Visit on Apr/09/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Apr/9/2021
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 [AA11363]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495850
Page 59 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 6 -
Unscheduled Visit on Apr/23/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/23/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK12
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495851
Page 60 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 6 -
Unscheduled Visit on Apr/23/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Apr/23/2021
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 [AA09887]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495852
Page 61 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 7 -
Unscheduled Visit on May/07/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/7/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK14
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495853
Page 62 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 7 -
Unscheduled Visit on May/07/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
May/7/2021
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 [AA09890]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495854
Page 63 of 269
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Feb/26/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495855
Page 64 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/13/2021
2.Erroneous Visit
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495856
Page 65 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495857
Page 66 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495858
Page 67 of 269
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#CategoryAE Iden
tifierAdverse Ev
entStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Bilateral kn
ee pain Jan/11/2021
12:00 NO
End Date Time:
Feb/15/2021 12:00
Repeating
Pages
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495859
Page 68 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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)[Bilateral knee pain]
4.Start Date Time: Jan/11/2021 12:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/15/2021 12:00
6.Toxicity Grade: 2
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495860
Page 69 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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:
[overuse injury from running, patellar tendonitis]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495861
Page 70 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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[ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495862
Page 71 of 269
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495863
Page 72 of 269
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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[ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495864
Page 73 of 269
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495865
Page 74 of 269
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495866
Page 75 of 269
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495867
Page 76 of 269
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495868
Page 77 of 269
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495869
Page 78 of 269
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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?
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495870
Page 79 of 269
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495871
Page 80 of 269
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495872
Page 81 of 269
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : May/13/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495873
Page 82 of 269
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495874
Page 83 of 269
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495875
Page 84 of 269
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/20/2021
2.Erroneous Visit
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495876
Page 85 of 269
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
May/20/2021
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495877
Page 86 of 269
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 28-Mar-2021 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495878
Page 87 of 269
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :May/20/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495879
Page 88 of 269
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
May/20/2021
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 [BNWYBR]
5.bSample ID [BNWYBJ]
5.cSample ID [BRMJ2N]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495880
Page 89 of 269
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
May/20/2021
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 [BRMJ39]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495881
Page 90 of 269
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: May/20/2021 16:48
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495882
Page 91 of 269
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/10/2021
2.Erroneous Visit
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495883
Page 92 of 269
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jun/10/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMJ6D]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495884
Page 93 of 269
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jun/10/2021 11:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495885
Page 94 of 269
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/16/2021
2.Erroneous Visit
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495886
Page 95 of 269
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/16/2021
3.Comments: [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495887
Page 96 of 269
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495888
Page 97 of 269
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495889
Page 98 of 269
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495890
Page 99 of 269
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495891
Page 100 of 269
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Aug/16/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495892
Page 101 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Feb/26/2021
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495893
Page 102 of 269
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495894
Page 103 of 269
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Emmanuel
Walter Approved Aug-18-2021 22:14:54 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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.
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495895
Page 104 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJan-19-2021 13:56:00 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495896
Page 105 of 269
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 28-Mar-2021 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMay-20-2021 17:16:11
(UTC-05:00) Eastern Time (US &
Canada)Brenderia
CameronNot Applicable
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0495897
Page 106 of 269
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Emmanuel
Walter Approved Aug-18-2021 22:14:54 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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 Aug-18-2021 13:49:37 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved Aug-17-2021 10:43:23 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0495898
Page 107 of 269
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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 Aug-17-2021 09:41:42 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved Jun-19-2021 17:50:36 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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.
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0495899
Page 108 of 269
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
N/A Jun-14-2021 16:17:58 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved Jun-10-2021 16:31:07 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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.
Brenderia
Cameron N/A Jun-10-2021 16:12:20 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved Jun-01-2021 20:51:07 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0495900
Page 109 of 269
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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 May-20-2021 09:26:33 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved May-14-2021 16:36:30 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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.
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0495901
Page 110 of 269
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
N/A May-07-2021 14:42:47 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved May-05-2021 15:57:21 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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 Apr-26-2021 13:12:25 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved Apr-14-2021 19:54:12 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0495902
Page 111 of 269
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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.
Brenderia
Cameron N/A Apr-12-2021 09:16:03 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved Mar-29-2021 13:14:22 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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.
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495903
Page 112 of 269
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
N/A Mar-29-2021 12:42:01 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved Mar-15-2021 20:17:04 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EmmanuelWalter, verify that all case report form pages
accurately display the results of the examinations, tests, evaluations and treatments performed on
this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Mar-15-2021 10:03:59 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved Mar-05-2021 16:09:20 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0495904
Page 113 of 269
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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-26-2021 13:39:30 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved Feb-18-2021 14:13:13 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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.
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0495905
Page 114 of 269
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
N/A Feb-16-2021 12:51:27 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved Feb-14-2021 20:46:09 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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 11:56:37 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved Feb-09-2021 16:06:12 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0495906
Page 115 of 269
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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-09-2021 11:41:12 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved Feb-06-2021 08:31:31 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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.
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0495907
Page 116 of 269
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
N/A Feb-04-2021 09:54:58 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved Feb-03-2021 21:50:17 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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-03-2021 17:23:50 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved Feb-02-2021 09:11:52 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0495908
Page 117 of 269
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Affidavit:
By my dated signature below, I, EmmanuelWalter, verify that all case report form pages
accurately display the results of the examinations, tests, evaluations and treatments performed on
this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Jan-29-2021 16:56:33 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emmanuel
Walter Approved Jan-28-2021 09:50:25 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EmmanuelWalter, 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.
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0495909
Page 118 of 269
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Jan-19-2021
13:55:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
01 DEC 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jan-19-2021
13:55:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495910
Page 119 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-19-2021
13:55:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Obta
ined
Jan/8/2021Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495911
Page 120 of 269
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Subject ID
Date Location User Value Reason
Jan-19-2021 13:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
11391246Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Jan-19-2021 13:54:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
/2005Enrollment Entry
3. Sex:
Date Location User Value Reason
Jan-19-2021
13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jan-19-2021
13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495912
Page 121 of 269
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5. Race: (Check X all that apply):
Date Location User Value Reason
Jan-19-2021
13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
WHITEInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495913
Page 122 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021
13:55:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/8/2021Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495914
Page 123 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Jan-19-2021
13:56:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/8/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-19-2021 13:56:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jan-19-2021
13:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495915
Page 124 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.a
Date Location User Value Reason
Jan-19-2021 13:56:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Acne
Start Date: Jun/30/20
19
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jan-19-2021 13:56:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-19-2021
13:56:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
AcneInitial Entry
1.a Start Date:
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495916
Page 125 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-19-2021
13:56:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jun/30/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jan-19-2021
13:56:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Jan-19-2021 13:57:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical Histor
y Term:dyslexia
Start Date: UNK/UNK
/2005
Ongoing: YESInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495917
Page 126 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.b Line/MH Number:
Date Location User Value Reason
Jan-19-2021 13:57:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-19-2021
13:57:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
dyslexiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Jan-19-2021
13:57:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jan-19-2021
13:57:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
1.c
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495918
Page 127 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-19-2021 13:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical Histor
y Term:sleep distur
bance
Start Date: Jun/30/201
5
Ongoing: YESInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495919
Page 128 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.c Line/MH Number:
Date Location User Value Reason
Jan-19-2021 13:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-19-2021
13:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
sleep disturbanceInitial Entry
1.c Start Date:
Date Location User Value Reason
Jan-19-2021
13:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jun/30/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Jan-19-2021
13:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
1.d
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495920
Page 129 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-19-2021
13:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Line/MH N
umber:4
Medical His
tory Term:intermittent
muscle strain
Start Date: Jun/30/2018
Ongoing: YESInitial Entry
Jan-19-2021
13:58:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:intermittent
muscle strain
Start Date: Jun/30/2018
Ongoing:Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495921
Page 130 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.d Line/MH Number:
Date Location User Value Reason
Jan-19-2021 13:58:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-19-2021
13:58:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
intermittent muscle strainInitial Entry
1.d Start Date:
Date Location User Value Reason
Jan-19-2021
13:58:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jun/30/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Jan-19-2021
13:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495922
Page 131 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Jan-19-2021
13:58:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
The subject is NOT known t
o be HIV POSITIVEInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495923
Page 132 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:19 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-26-2021
04:43:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Jan-25-2021
12:15:40
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Answered Original value is
correct
Jan-19-2021
14:00:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Opened Vital Signs Date
is not the same
as Vaccination
Date in the same
visit. Please
review and
update as
appropriate or
clarify.
Jan-19-2021
13:59:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/8/2021Initial Entry
2. Weight:
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495924
Page 133 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:19 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-19-2021
13:59:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
158.0Initial Entry
3. Unit:
Date Location User Value Reason
Jan-19-2021
13:59:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Mar-01-2021
18:52:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Closed Response
satisfies query
Feb-26-2021
13:39:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 2: Answered Changed
Information
Feb-26-2021
13:39:30
(UTC-05:00)
Eastern Time (US &ACV0PF
EINFP60
00 Data Entry:
70.5Changed
Information
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0495925
Page 134 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:19 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada)
Feb-19-2021
16:05:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Opened CLINQUERY:
Query response
confirms height
of 178.7 inches.
Please verify as
this appears to
be the
measurement in
cm. Please
calculate correct
result in inches
so that BMI can
be calculated
correctly.
Jan-19-2021
23:58:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Jan-19-2021
13:59:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Answered Original value is
correct
Jan-19-2021
13:59:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Opened Height 178.7 is
outside of
Normal Range
140 - 198 for cm
or 55 - 80 for in.
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0495926
Page 135 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:19 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-19-2021
13:59:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
178.7Initial Entry
5. Unit:
Date Location User Value Reason
Jan-19-2021
13:59:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Feb-26-2021
13:39:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
22.3Changed
Information
Feb-01-2021
18:42:52
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Jan-29-2021
16:55:52
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Answered Original value is
correct
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495927
Page 136 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:19 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-26-2021
19:48:56
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Reissued:Opened ClinQuery:the
derived BMI for
this subject is
3.5. Please
review
height/weight
and all units and
confirm this
information is
entirely correct.
thanks
Jan-25-2021
12:15:59
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Answered Original value is
correct
Jan-20-2021
20:11:27
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened ClinQuery:
Please can you
review the
height/weight
combinations for
this subject as
the derived BMI
is further out of
range than
expected. Thank
you
Jan-19-2021
13:59:02
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
3.5Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495928
Page 137 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:19 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.a
Date Location User Value Reason
Jan-19-2021
13:59:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identifi
er::1
Temperature: 98.1
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Jan-19-2021
13:59:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jan-19-2021
13:59:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495929
Page 138 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:19 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-19-2021
13:59:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Jan-19-2021
13:59:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495930
Page 139 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Jan-19-2021
13:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/8/2021Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jan-19-2021
13:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
26319Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495931
Page 140 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021 13:59:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 13:59:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-25-2021
16:02:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-20-2021
07:26:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495932
Page 141 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-19-2021
13:59:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Jan-19-2021
13:59:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/8/2021Initial Entry
5.a
Date Location User Value Reason
Jan-25-2021
16:02:53
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BP8N55Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-25-2021
16:02:53
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BP8N55Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495933
Page 142 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b
Date Location User Value Reason
Jan-25-2021
16:03:07
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BP8N56Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-25-2021
16:03:07
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BP8N56Initial Entry
5.c
Date Location User Value Reason
Jan-25-2021
16:03:25
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BP8N57Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495934
Page 143 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.c Sample ID
Date Location User Value Reason
Jan-25-2021
16:03:25
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BP8N57Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495935
Page 144 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021 14:00:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 14:00:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-26-2021
09:47:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Jan-25-2021
15:53:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 2: Closed Close Auto
Query
Jan-25-2021 ACV0PF auto query Query 3: Closed Close Auto
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495936
Page 145 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
12:17:16
(UTC-05:00)
Eastern Time (US &
Canada)EINFP60
00 (autoquery) Query
Jan-25-2021
12:17:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/8/2021Transcription
Error
Jan-25-2021
12:17:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Answered Changed data
per query
Jan-25-2021
12:16:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 3: Opened Nasal Swab
sample is
collected after
Vaccination 1,
however
response to “If
no sample was
collected or
sample was not
collected
according to
protocol, please
provide reason:"
is missing.
Please update.
Jan-20-2021
07:26:26ACV0PF
EINFP60Query 2: Opened 'Sample
Collected?' is
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495937
Page 146 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00)
Eastern Time (US &
Canada)00 Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Jan-19-2021
14:00:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 2: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Jan-19-2021
14:00:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Opened Date of
Collection
11/Jan/2021 is
more than 1 day
after Date of
Visit 08/Jan
/2021. Please
review and
update as
appropriate, else
clarify.
Jan-19-2021
14:00:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/11/2021Initial Entry
5.a
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495938
Page 147 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-25-2021
15:53:00
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BP8N5FInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-25-2021
15:53:00
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BP8N5FInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495939
Page 148 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-19-2021
14:00:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-19-2021 14:00:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jan-19-2021 14:00:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-27-2021
03:36:19
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Closed Data updated by
site.
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0495940
Page 149 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-26-2021
19:46:43
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Query 3: Closed Response
satisfies query
Jan-25-2021
12:16:45
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 3: Answered Transcription
Error
Jan-25-2021
12:16:45
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 2: Answered Transcription
Error
Jan-25-2021
12:16:45
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-25-2021
12:16:45
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/8/2021 16:52Transcription
Error
Jan-20-2021
20:11:55
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Query 3: Opened ClinQuery:
Please can you
review the 3 day
discrepancy
between rand
and vax1 and
update as
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495941
Page 150 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate?
Thank you
Jan-20-2021
03:45:33
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Opened eDiary: Per
eDiary records,
vaccination date
is 08-Jan-2021.
Please reconcile
or confirm in the
query response
as appropriate.
Jan-19-2021
14:00:26
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Opened Dose Date is
before or more
than 1 day after
Date of Visit
08/Jan/2021 of
the
corresponding
Visit. Please
review and
update as
appropriate.
Jan-19-2021
14:00:26
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/11/2021 16:52Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-19-2021 14:00:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0495942
Page 151 of 269
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
6. Body Side:
Date Location User Value Reason
Jan-19-2021
14:00:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-19-2021 14:00:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-19-2021 14:00:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Jan-19-2021
14:00:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495943
Page 152 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Jan-19-2021
14:00:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED F
OR THIS SUBJECTInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495944
Page 153 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-29-2021
16:56:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/29/2021Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495945
Page 154 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FE
V
ER
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?
:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FEVERInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495946
Page 155 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495947
Page 156 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was comp
leted?:NOInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495948
Page 157 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HI
LL
S
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495949
Page 158 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495950
Page 159 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495951
Page 160 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.f Symptom:
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Feb-16-2021
12:51:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAINTranscription
Error
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495952
Page 161 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or
systemic sym
ptoms present
on the last da
y the Subject
Diary was co
mpleted?:YES
Ongoing?
NO
Stop D
ate:
Jan/1
5/202
1
Feb-11-2021
11:56:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or
systemic sym
ptoms present
on the last da
y the Subject
Diary was co
mpleted?:YES
Ongoing?
NO
Stop D
ate:
Jan/9
/2021Transcription
Error
Feb-09-2021
11:41:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAINTranscription
Error
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495953
Page 162 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or
systemic sym
ptoms present
on the last da
y the Subject
Diary was co
mpleted?:YES
Ongoing?
NO
Stop D
ate:
Jan/3
1/202
1
Jan-29-2021
16:57:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495954
Page 163 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.g Symptom:
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED MU
SCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-17-2021
04:48:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Data Updated
Feb-16-2021
12:51:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Answered Transcription
Error
Feb-16-2021
12:51:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Ongoing?
NO
Stop Date:
Jan/15/2021Transcription
Error
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495955
Page 164 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-12-2021
04:43:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Reissued:O
penedeDiary RQ2: Per
eDiary record,
on last day
14-Jan-
2021(Day 7)
'New or
worsened
muscle pain
occurrence' is
reported.
However, in
Inform, stop
date is provided
as 09-Jan-2021.
Please review
and consider to
update
appropriate stop
date, else clarify.
Thanks
Feb-11-2021
11:56:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Answered Transcription
Error
Feb-11-2021
11:56:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Ongoing?
NO
Stop Date:Transcription
Error
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495956
Page 165 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan/9/2021
Feb-10-2021
04:01:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Reissued:O
penedeDiary: V2
Vaccination date
is 29Jan2021.
However, for
'New or
worsened
muscle pain'
stop date is
provided as
31Jan2021.
Please confirm
'Muscle Pain'
reported post
Vaccination 1
was ongoing
through
Vaccination 2.
Else, update
appropriate stop
date. Thanks
Feb-09-2021
11:41:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Answered Transcription
Error
Feb-09-2021
11:41:12
(UTC-05:00)
Eastern Time (USACV0PF
EINFP60
00 Data Entry:
YES
Ongoing?Transcription
Error
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495957
Page 166 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
& Canada) NO
Stop Date:
Jan/31/2021
Feb-01-2021
05:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy PFE SDQ PROD Query 1: Opened eDiary: Per
eDiary records,
"New or
worsened
muscle pain
occurrence" is
reported on Last
day (Day 7)
however the last
day in Inform
CRF data is
entered as No
for the same.
Please verify
and update.
Else, clarify.
Thanks
Jan-29-2021
16:57:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0495958
Page 167 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Feb-16-2021
12:51:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or
systemic symp
toms present o
n the last day
the Subject Di
ary was compl
eted?:YES
Ongoing?
NO
Stop D
ate:
Jan/1
5/20
21Transcription
Error
Feb-11-2021
11:56:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAINTranscription
Error
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495959
Page 168 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or
systemic symp
toms present o
n the last day
the Subject Di
ary was compl
eted?:YES
Ongoing?
NO
Stop D
ate:
Jan/9
/202
1
Feb-09-2021
11:41:29
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or
systemic symp
toms present o
n the last day
the Subject Di
ary was compl
eted?:YES
Ongoing?
NO
Stop D
ate:
Jan/3
1/20
21Transcription
Error
Jan-29-2021
16:57:22
(UTC-05:00)
Eastern Time (US &ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENEDInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495960
Page 169 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada) JOINT
PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:NO
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495961
Page 170 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.h Symptom:
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-17-2021
04:49:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Data Updated
Feb-16-2021
12:51:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Answered Transcription
Error
Feb-16-2021
12:51:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Ongoing?
NO
Stop Date:
Jan/15/2021Transcription
Error
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495962
Page 171 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-12-2021
04:44:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Reissued:O
penedeDiary RQ2: Per
eDiary record,
on last day
14-Jan-
2021(Day 7)
'New or
worsened joint
pain occurrence'
is reported.
However, in
Inform, stop
date is provided
as 09-Jan-2021.
Please review
and consider to
update
appropriate stop
date, else clarify.
Thanks
Feb-11-2021
11:56:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Answered Transcription
Error
Feb-11-2021
11:56:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Ongoing?
NO
Stop Date:Transcription
Error
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495963
Page 172 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan/9/2021
Feb-10-2021
04:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Reissued:O
penedeDiary: V2
Vaccination date
is 29Jan2021.
However, for
'New or
worsened joint
pain' stop date is
provided as
31Jan2021.
Please confirm
'Joint Pain'
reported post
Vaccination 1
was ongoing
through
Vaccination 2.
Else, update
appropriate stop
date. Thanks
Feb-09-2021
11:41:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Answered Transcription
Error
Feb-09-2021
11:41:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Ongoing?
NOTranscription
Error
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495964
Page 173 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Stop Date:
Jan/31/2021
Feb-01-2021
05:04:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy PFE SDQ PROD Query 1: Opened eDiary: Per
eDiary records,
"New or
worsened joint
pain occurrence"
is reported on
Last day (Day 7)
however the last
day in Inform
CRF data is
entered as No
for the same.
Please verify
and update.
Else, clarify.
Thanks
Jan-29-2021
16:57:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Jan-29-2021 16:57:22 ACV0PF auto calc Data Entry: Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0495965
Page 174 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00) Eastern
Time (US & Canada)EINFP60
00 (autocalc) DELTOID MUSCLE
4. Injection Site Body Side:
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
REDNESSInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495966
Page 175 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reacti
on::SW
ELL
ING
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495967
Page 176 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Injection Site Reaction:
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reac
tion::PAIN
AT IN
JECTI
ON SI
TE
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:NOInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495968
Page 177 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.c Injection Site Reaction:
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-29-2021
16:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495969
Page 178 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-29-2021
16:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/29/2021Initial Entry
2.a
Date Location User Value Reason
Jan-29-2021
16:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identifi
er::1
Temperature: 98.6
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-29-2021
16:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
2.a Temperature:
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495970
Page 179 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-29-2021
16:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
98.6Initial Entry
2.a Unit:
Date Location User Value Reason
Jan-29-2021
16:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Jan-29-2021
16:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495971
Page 180 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-29-2021 16:57:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 16:57:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-04-2021
09:54:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-31-2021
22:05:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495972
Page 181 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-29-2021
16:57:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Jan-29-2021
16:57:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/29/2021Initial Entry
5.a
Date Location User Value Reason
Feb-04-2021
09:54:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR5RCKInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-04-2021
09:54:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BR5RCKInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495973
Page 182 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-29-2021
17:04:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-29-2021 17:04:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jan-29-2021 17:04:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-29-2021
17:04:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/29/2021 13:53Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495974
Page 183 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5. Anatomical Location:
Date Location User Value Reason
Jan-29-2021 17:04:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-29-2021
17:04:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-29-2021 17:04:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-29-2021 17:04:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495975
Page 184 of 269
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-29-2021
17:04:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495976
Page 185 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021
16:50:48
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/26/2021Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495977
Page 186 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FE
V
E
R
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Feb-26-2021
16:51:30ACV0PF
EINFP60Data Entry:
FEVERInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495978
Page 187 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00) Eastern
Time (US &
Canada)00
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495979
Page 188 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495980
Page 189 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HI
LL
S
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:N
OInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495981
Page 190 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or syste
mic symptoms prese
nt on the last day the
Subject Diary was co
mpleted?:NOInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495982
Page 191 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495983
Page 192 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.f Symptom:
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAINInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495984
Page 193 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NO
2.g Symptom:
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED M
USCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) EasternACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WORInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495985
Page 194 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US &
Canada)SENED
JOINT
PAIN
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NO
2.h Symptom:
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED JO
INT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495986
Page 195 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495987
Page 196 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reacti
on::SW
ELL
ING
Were injection site r
eactions present on t
he last day the Subje
ct Diary was comple
ted?:NOInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495988
Page 197 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Injection Site Reaction:
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Rea
ction::PAIN
AT IN
JECTI
ON SI
TEInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495989
Page 198 of 269
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were injection site
reactions present
on the last day the
Subject Diary was
completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
PAIN AT INJECTION SIT
EInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-26-2021
16:51:30
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495990
Page 199 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021
16:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021
16:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-01-2021
16:07:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-01-2021
06:04:36
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495991
Page 200 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Feb-26-2021
16:51:42
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Feb-26-2021
16:51:42
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Feb/26/2021Initial Entry
5.a
Date Location User Value Reason
Mar-01-2021
16:07:20
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BNWY4PInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-01-2021
16:07:20
(UTC-05:00) EasternACV0PF
EINFP60
00 Data Entry:
BNWY4PInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495992
Page 201 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US &
Canada)
5.b
Date Location User Value Reason
Mar-01-2021
16:07:37
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRMJV2Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-01-2021
16:07:37
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRMJV2Initial Entry
5.c
Date Location User Value Reason
Mar-01-2021
16:07:46
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRMJV3Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495993
Page 202 of 269
***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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.c Sample ID
Date Location User Value Reason
Mar-01-2021
16:07:46
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRMJV3Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0495994
Page 203 of 269
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-29-2021
17:05:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/29/2021Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495995
Page 204 of 269
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-29-2021
17:05:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Obta
ined
Jan/29/2021Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495996
Page 205 of 269
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-29-2021 17:05:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 17:05:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-03-2021
17:23:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-31-2021
22:05:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495997
Page 206 of 269
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-29-2021
17:05:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Jan-29-2021
17:05:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/29/2021Initial Entry
5.a
Date Location User Value Reason
Feb-03-2021
17:23:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR5RD8Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-03-2021
17:23:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BR5RD8Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495998
Page 207 of 269
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b
Date Location User Value Reason
Feb-03-2021
17:43:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR5RD6Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-03-2021
17:43:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BR5RD6Initial Entry
5.c
Date Location User Value Reason
Feb-03-2021
17:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR5RD7Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-03-2021
17:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BR5RD7Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0495999
Page 208 of 269
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-29-2021 17:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 17:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-04-2021
10:00:23
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-31-2021
22:05:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496000
Page 209 of 269
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-29-2021
17:05:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Jan-29-2021
17:05:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/29/2021Initial Entry
5.a
Date Location User Value Reason
Feb-04-2021
10:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR5RCMInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-04-2021
10:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BR5RCMInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0496001
Page 210 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/12/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-16-2021
12:52:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/12/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-16-2021
12:52:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
SSWAB_WEEK2Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0496002
Page 211 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/12/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-16-2021
12:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-16-2021
12:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-16-2021
12:53:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-16-2021
12:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0496003
Page 212 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/12/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
correct as
appropriate.
Feb-16-2021
12:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Feb/12/2021Initial Entry
5.a
Date Location User Value Reason
Feb-16-2021
12:53:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: AA09865Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-16-2021
12:53:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
AA09865Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0496004
Page 213 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/26/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-05-2021
00:15:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Response satisfies
query
Mar-04-2021
13:03:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Answered I'm not understand
the duplicate query.
Visit 03 was the
same day as when
they were due to
swab for week 4
Mar-02-2021
06:28:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Reissued:
OpenedDM1: Thanks for
your response. The
Date of Visit at
Visit at Visit
‘COVID-19
Surveillance Visit
=
SSWAB_WEEK4’
is the same as the
other Date of Visit
at Visit
V3POSTVX2L.
Please review for
duplication and
update as
appropriate.
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496005
Page 214 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/26/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-01-2021
15:21:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Answered Original value is
correct
Mar-01-2021
10:01:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy DMW QUERY Query 1: Opened DMW7482491;The
Date of Visit at
Visit at Visit
‘COVID-19
Surveillance Visit
=
SSWAB_WEEK4’
is the same as the
other Date of Visit
at Visit
V3POSTVX2L.
Please review for
duplication and
update as
appropriate.
Feb-26-2021
16:52:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/26/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-26-2021
16:52:13
(UTC-05:00) EasternACV0PF
EINFP60
00 Data Entry:
SSWAB_WEEK4Initial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0496006
Page 215 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/26/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US &
Canada)
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496007
Page 216 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/26/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021
16:52:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-01-2021
15:22:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NASAL_SWABTranscription
Error
Feb-26-2021
16:52:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-01-2021
15:22:03
(UTC-05:00)
Eastern Time (US &ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0496008
Page 217 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/26/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada)
Mar-01-2021
06:04:36
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Feb-26-2021
16:52:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Feb-26-2021
16:52:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Feb/26/2021Initial Entry
5.a
Date Location User Value Reason
Mar-01-2021
15:22:03
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRMJTZInitial Entry
090177e19891a03a\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2022-5812-0496009
Page 218 of 269
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/26/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1139 Site Name: (1139) Duke University Medical Center
Subject No: 11391246 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.a Sample ID
Date Location User Value Reason
Mar-01-2021
15:22:16
(UTC-05:00)
Eastern Time (US
& Canada)A
…[truncated]