Document text
Page 1 of 206
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956999
Page 2 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/7/2020
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957000
Page 3 of 206
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Demography
1.Subject ID [10821083]
2.Birth Date: /1984
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:
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957001
Page 4 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/7/2020
2.Erroneous Visit
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957002
Page 5 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957003
Page 6 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957004
Page 7 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[anxiety]
Start Date: Apr/2/2020
Ongoing: YES
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957005
Page 8 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Aug/7/2020
2.Weight: [108.4]
3.Unit: kg
4.Height: [177.2]
5.Unit: cm
6.Body Mass Index: [34.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957006
Page 9 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/7/2020
2.Randomization Number: [44629]
3.Randomization Group: [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957007
Page 10 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/7/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3NNV]
5.bSample ID [BP3NNW]
5.cSample ID [BP3NNX]
5.dSample ID [BPLDHG]
5.eSample ID [BPLDHH]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957008
Page 11 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/7/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3NNT]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957009
Page 12 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/7/2020 14:58
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957010
Page 13 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957011
Page 14 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957012
Page 15 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957013
Page 16 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957014
Page 17 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
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
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957015
Page 18 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957016
Page 19 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3P0F]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957017
Page 20 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/28/2020 09:03
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
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957018
Page 21 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957019
Page 22 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957020
Page 23 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957021
Page 24 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957022
Page 25 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY6V7]
5.bSample ID [BPLDV8]
5.cSample ID [BPLDV7]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957023
Page 26 of 206
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957024
Page 27 of 206
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/18/2021
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 [BRDWMV]
5.bSample ID [BS3G33]
5.cSample ID [BS3G34]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957025
Page 28 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957026
Page 29 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957027
Page 30 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957028
Page 31 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957029
Page 32 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957030
Page 33 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957031
Page 34 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957032
Page 35 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957033
Page 36 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957034
Page 37 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Unplanned Assessments
1.Assessments
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957035
Page 38 of 206
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Sep/25/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957036
Page 39 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957037
Page 40 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957038
Page 41 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957039
Page 42 of 206
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#CategoryAE Ide
ntifierAdverse Ev
entStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 myocardial i
nfarction Oct/28/2020
UNK:UNK NO
End Date Time:
Nov/4/2020 UNK:
UNK
Repeating
Pages
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957040
Page 43 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[myocardial infarction]
4.Start Date Time: Oct/28/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/4/2020 UNK:UNK
6.Toxicity Grade: 4
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957041
Page 44 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown etiology]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957042
Page 45 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?: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[2021187575]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957043
Page 46 of 206
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957044
Page 47 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957045
Page 48 of 206
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957046
Page 49 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: //
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957047
Page 50 of 206
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957048
Page 51 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957049
Page 52 of 206
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957050
Page 53 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957051
Page 54 of 206
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957052
Page 55 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957053
Page 56 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957054
Page 57 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957055
Page 58 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957056
Page 59 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957057
Page 60 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957058
Page 61 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957059
Page 62 of 206
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Not Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957060
Page 63 of 206
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/15/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957061
Page 64 of 206
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957062
Page 65 of 206
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957063
Page 66 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957064
Page 67 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/1/2021
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957065
Page 68 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957066
Page 69 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Mar/1/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957067
Page 70 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/1/2021
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 [BRDWNS]
5.bSample ID [BS3G4X]
5.cSample ID [BS3G4Y]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957068
Page 71 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/1/2021
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 [BRDWNR]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957069
Page 72 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/1/2021 08:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957070
Page 73 of 206
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957071
Page 74 of 206
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957072
Page 75 of 206
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957073
Page 76 of 206
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957074
Page 77 of 206
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957075
Page 78 of 206
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957076
Page 79 of 206
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957077
Page 80 of 206
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957078
Page 81 of 206
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957079
Page 82 of 206
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957080
Page 83 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/25/2020
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957081
Page 84 of 206
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957082
Page 85 of 206
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957083
Page 86 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-10-2020 08:46:31 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957084
Page 87 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormMar-12-2021 11:18:40 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957085
Page 88 of 206
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-12-2021 10:59:16 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Smith Approved Mar-02-2021 18:23:34 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamSmith, 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-25-2021 10:18:54 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957086
Page 89 of 206
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Affidavit:
N/A
William
Smith Approved Feb-25-2021 10:08:22 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamSmith, 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-24-2021 12:19:50 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Smith Approved Feb-22-2021 10:42:02 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957087
Page 90 of 206
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Affidavit:
By my dated signature below, I, WilliamSmith, 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-17-2021 15:34:39 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Smith Approved Feb-15-2021 11:21:42 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957088
Page 91 of 206
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Affidavit:
By my dated signature below, I, WilliamSmith, 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-12-2021 11:51:24 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Smith Approved Oct-06-2020 16:51:05 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957089
Page 92 of 206
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Affidavit:
By my dated signature below, I, WilliamSmith, 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 Sep-29-2020 11:35:33 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Smith Approved Sep-11-2020 14:15:10 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957090
Page 93 of 206
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Affidavit:
By my dated signature below, I, WilliamSmith, 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-31-2020 07:56:18 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Smith Approved Aug-14-2020 19:44:55 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957091
Page 94 of 206
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Affidavit:
By my dated signature below, I, WilliamSmith, 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.
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957092
Page 95 of 206
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-07-2020
16:28:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-07-2020
16:28:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957093
Page 96 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-07-2020
16:28:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent
Obtained
Aug/7/2020Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957094
Page 97 of 206
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-07-2020
16:28:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10821083Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-07-2020
16:28:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1984Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-07-2020
16:28:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957095
Page 98 of 206
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-07-2020
16:28:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR L
ATINO(A) OR OF SP
ANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-07-2020
16:28:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957096
Page 99 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-10-2020
08:46:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/7/2020Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957097
Page 100 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-10-2020
08:46:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-10-2020
08:46:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-10-2020
08:46:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957098
Page 101 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.a
Date Location User Value Reason
Aug-10-2020
08:53:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:anxiet
y
Start Date: Apr/2/
2020
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-10-2020
08:53:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-10-2020
08:53:16
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
anxietyInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957099
Page 102 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-10-2020
08:53:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Apr/2/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-10-2020
08:53:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957100
Page 103 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Aug-10-2020
08:51:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/7/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-10-2020
08:51:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
108.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-10-2020
08:51:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957101
Page 104 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Aug-10-2020
08:51:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
177.2Initial Entry
5. Unit:
Date Location User Value Reason
Aug-10-2020
08:51:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-10-2020
08:51:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
34.5Initial Entry
7.a
Date Location User Value Reason
Aug-10-2020
08:51:51
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Record Ide 1Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957102
Page 105 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Eastern Time (US
& Canada)ntifier::
Temperatur
e:36.8
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-10-2020
08:51:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-10-2020
08:51:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957103
Page 106 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-10-2020
08:51:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-10-2020
08:51:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957104
Page 107 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-10-2020
08:48:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/7/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-10-2020
08:48:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
44629Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957105
Page 108 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-10-2020
10:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-10-2020
10:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-10-2020
10:35:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-10-2020
10:34:59ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957106
Page 109 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-10-2020
10:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/7/2020Initial Entry
5.a
Date Location User Value Reason
Aug-10-2020
10:35:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP3NN
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-10-2020
10:35:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3NNVInitial Entry
5.b
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957107
Page 110 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Aug-10-2020
10:35:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP3NN
WInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-10-2020
10:35:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3NNWInitial Entry
5.c
Date Location User Value Reason
Aug-10-2020
10:35:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP3NN
XInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957108
Page 111 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.c Sample ID
Date Location User Value Reason
Aug-10-2020
10:35:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3NNXInitial Entry
5.d
Date Location User Value Reason
Aug-10-2020
10:35:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPLDH
GInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-10-2020
10:35:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPLDHGInitial Entry
5.e
Date Location User Value Reason
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957109
Page 112 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-10-2020
10:35:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPLDH
HInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-10-2020
10:35:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPLDHHInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957110
Page 113 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-10-2020
10:34:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-10-2020
10:34:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-10-2020
10:34:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-10-2020
10:34:20ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957111
Page 114 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-10-2020
10:34:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/7/2020Initial Entry
5.a
Date Location User Value Reason
Aug-10-2020
10:34:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3NNTInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-10-2020
10:34:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3NNTInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957112
Page 115 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-10-2020
08:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-10-2020
08:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-10-2020
08:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957113
Page 116 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-10-2020
08:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/7/2020 14:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-10-2020
08:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-10-2020
08:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-10-2020
08:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957114
Page 117 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-10-2020
08:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-10-2020
08:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957115
Page 118 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-10-2020
08:46:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENI
CITY E-DIARY COL
LECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957116
Page 119 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020
07:56:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957117
Page 120 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957118
Page 121 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957119
Page 122 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.b Symptom:
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 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
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957120
Page 123 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NO
2.c Symptom:
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 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
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-31-2020
07:57:52ACV0PFEINFP6000 Data Entry:
Symptom:: CInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957121
Page 124 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)HI
L
LS
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
O
2.d Symptom:
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 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
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957122
Page 125 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 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
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957123
Page 126 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.f
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NOInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957124
Page 127 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.f Symptom:
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 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
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
INInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957125
Page 128 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.g Symptom:
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957126
Page 129 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:NOInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957127
Page 130 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.h Symptom:
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957128
Page 131 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions pres
ent on the last da
y the Subject Dia
ry was complete
d?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957129
Page 132 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NOInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957130
Page 133 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 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
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTIO
N SI
TEInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957131
Page 134 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 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
Aug-31-2020
07:57:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957132
Page 135 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020
07:59:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2.a
Date Location User Value Reason
Aug-31-2020
07:59:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.8
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-31-2020
07:59:59
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957133
Page 136 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Eastern Time (US
& Canada)
2.a Temperature:
Date Location User Value Reason
Aug-31-2020
07:59:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-31-2020
07:59:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Aug-31-2020
07:59:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957134
Page 137 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020
07:56:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020
07:56:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020
07:56:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-31-2020
07:56:26ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957135
Page 138 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-31-2020
07:56:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020
07:56:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3P0FInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020
07:56:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3P0FInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957136
Page 139 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-31-2020
07:57:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020
07:57:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020
07:57:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957137
Page 140 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-31-2020
07:57:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 09:03Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020
07:57:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020
07:57:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-31-2020
07:57:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957138
Page 141 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020
07:57:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-31-2020
07:57:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957139
Page 142 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-29-2020
11:35:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957140
Page 143 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
OInitial Entry
2.a Symptom:
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957141
Page 144 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
EInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957142
Page 145 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
O
2.b Symptom:
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 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
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-29-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957143
Page 146 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)Symptom:: HE
A
D
AC
HE
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was complet
ed?:N
O
2.c Symptom:
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 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
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957144
Page 147 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.d
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
L
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957145
Page 148 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.d Symptom:
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 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
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NGInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957146
Page 149 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:NO
2.e Symptom:
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 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
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-29-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957147
Page 150 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)Symptom:: DI
A
RR
HE
A
Were fever or
systemic sympt
oms present on
the last day the
Subject Diary
was completed
?:N
O
2.f Symptom:
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 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
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957148
Page 151 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.g
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NOInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957149
Page 152 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.g Symptom:
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR
WOR
SENE
D JOI
NT P
AINInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957150
Page 153 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NO
2.h Symptom:
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957151
Page 154 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::RE
D
N
ES
S
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:N
OInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957152
Page 155 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 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
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::SW
EL
LI
NGInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957153
Page 156 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were injection
site reactions
present on the
last day the Su
bject Diary wa
s completed?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 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
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-29-2020
11:36:45ACV0PFEINFP6000 Data Entry:
Injection Site PAIInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957154
Page 157 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)Reaction:: N A
T IN
JEC
TIO
N SI
TE
Were injectio
n site reactio
ns present on
the last day t
he Subject Di
ary was com
pleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020
11:36:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957155
Page 158 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020
11:37:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020
11:37:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020
11:37:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-29-2020
11:37:11ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957156
Page 159 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-29-2020
11:37:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-29-2020
11:37:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPY6V
7Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020
11:37:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPY6V7Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957157
Page 160 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.b
Date Location User Value Reason
Oct-01-2020
12:57:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPLDV
8Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-01-2020
12:57:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPLDV8Initial Entry
5.c
Date Location User Value Reason
Oct-01-2020
12:57:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPLDV
7Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957158
Page 161 of 206
***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: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.c Sample ID
Date Location User Value Reason
Oct-01-2020
12:57:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPLDV7Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957159
Page 162 of 206
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021
02:56:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed As per site
confirmation -
updated PD
tracker
Mar-01-2021
11:01:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answe
reddate confirmed
as entered
Mar-01-2021
02:37:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opene
dPDQ: Date of
visit at
V4_MONTH6_L
is out of window
for -1 days from
V2_VAX2_L
DOV or V2
Vaccination date.
Please verify and
update. Else,
confirm in query
response
appropriately.
Feb-26-2021
13:02:54
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Feb/18/2021Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957160
Page 163 of 206
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Eastern Time
(US & Canada)
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957161
Page 164 of 206
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021
13:04:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021
13:04:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021
13:05:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-26-2021
13:04:31ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957162
Page 165 of 206
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-26-2021
13:04:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/18/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021
13:05:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRDWM
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-26-2021
13:05:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRDWMVInitial Entry
5.b
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957163
Page 166 of 206
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Feb-26-2021
13:06:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS3G33Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-26-2021
13:06:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BS3G33Initial Entry
5.c
Date Location User Value Reason
Feb-26-2021
13:06:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS3G34Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957164
Page 167 of 206
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.c Sample ID
Date Location User Value Reason
Feb-26-2021
13:06:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BS3G34Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957165
Page 168 of 206
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-05-2020
12:09:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Transcription
Error
Sep-30-2020
11:26:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-30-2020
11:26:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-30-2020
11:26:34ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957166
Page 169 of 206
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957167
Page 170 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Date Location User Value Reason
Feb-24-2021
12:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957168
Page 171 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Category:
Date Location User Value Reason
Feb-24-2021
12:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-24-2021
12:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-05-2021
21:08:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Query closed;
will follow for
requested
clinical course
information.
Mar-03-2021
12:29:18ACV0PFEINFP6000 Query 2: Answered SAE follow up
was sent last
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957169
Page 172 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)week with
narrative
update noting
the medical
records request
Mar-02-2021
22:51:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Reissued:
OpenedClinical -
Please submit
a SAE update
with
presenting
symptoms as
reported by
Subject. Please
request
medical
records for
additional info
Feb-25-2021
13:58:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered Site has not
received
medical
records for this
SAE. The
narrative of
the Follow Up
was updated to
include this
information.
Feb-25-2021
13:48:34
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Query 2: Opened Clinical Please
submit a SAE
update
reporting
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957170
Page 173 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
& Canada) subject's
presenting
symptoms,
exam,
diagnostic
workup,
treatment and
other
information
relevant to
causality
Feb-25-2021
13:44:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Fields
completed
Feb-25-2021
10:19:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered data updated
Feb-24-2021
15:07:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM: Please
complete
"Toxicity
Grade" and "Is
this event
related to
study
treatment"
fields.
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957171
Page 174 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Feb-24-2021
12:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
myocardial infarcti
onInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-24-2021
12:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/28/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-24-2021
12:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/4/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-08-2021
16:19:32
(UTC-05:00)ACV0PFEINFP6000 Query 2: Closed Query closed;
will follow for
requested
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957172
Page 175 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Eastern Time
(US & Canada)serious criteria
update.
Mar-08-2021
11:30:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answere
dSAE updated
Mar-05-2021
21:08:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissue
d:OpenedClinical - Thank
you; however in
the most recent
SAE update
(25Feb21) the
only serious
criterion
reported for the
SAE was HOSP.
Please update
SAE with
additional
criterion
Life-threatening
Mar-03-2021
12:28:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answere
dSAE follow up
was sent last
week. Initial
report listed the
serious criteria
noted.
Mar-02-2021
22:49:12
(UTC-05:00)ACV0PFEINFP6000 Query 2: Reissue
d:OpenedClinical - Thank
you; please
update the SAE
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957173
Page 176 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Eastern Time
(US & Canada)report with these
serious criteria
including
life-threatening
Feb-25-2021
14:08:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answere
ddata entry error
Feb-25-2021
13:46:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical Toxicity
Grade 4;
however, serious
criteria do not
include
life-threatening.
Based on Prot
Sect 10.3.3
Assessment of
Intensity, Grade
4 = Life
threatening
(Life-
threatening
consequences;
urgent
intervention).
Please review;
update where
needed
Feb-25-2021
13:44:01ACV0PFEINFP6000 Query 1: Closed Toxicity entered
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957174
Page 177 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time
(US & Canada)
Feb-25-2021
10:18:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dInitial Entry
Feb-25-2021
10:18:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
Feb-25-2021
02:59:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The
response for
"Toxicity
Grade" is
missing. Kindly
review and
update.
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957175
Page 178 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Mar-12-2021
15:36:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Closed Query closed;
will follow for
requested serious
criterion
information.
Mar-12-2021
07:33:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Answer
edcoordinator
resending SAE
report. it is noted
on report of
HOSP and
life-threatening.
Mar-11-2021
17:41:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Opened Clinical - serious
criteria are
HOSP and
Life-threatening;
however, SAE
report serious
criterion is
HOSP. Please
review,
harmonize
reporting, and
update where
applicable
Mar-05-2021
21:10:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Query closed;
will follow for
requested SAE
treatment
information.
Mar-05-2021 ACV0PFEINFP6000 Query 3: Closed Query closed;
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957176
Page 179 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
21:09:35
(UTC-05:00)
Eastern Time
(US & Canada)will follow for
requested
COVID test
information.
Feb-25-2021
14:08:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious e
vent associated
with congenital
anomaly or birt
h defect?
NO
Did this serious
event result in d
eath?
NO
Did this serious
event require or
prolong hospital
ization?
YES
Did this serious
event result in p
ersistent or sign
ificant disability
/incapacity?Transcription
Error
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957177
Page 180 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
NO
Is this serious e
vent life threate
ning?
YES
Other medically
important seriou
s event
NO
Feb-25-2021
13:58:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answer
edSite has not
received medical
records for this
SAE. The
narrative of the
Follow Up was
updated to
include this
information.
Feb-25-2021
13:58:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answer
edSite has not
received medical
records for this
SAE. The
narrative of the
Follow Up was
updated to
include this
information.
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957178
Page 181 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Feb-25-2021
13:50:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical COVID
test status
(yes/no) during
Hosp was not
reported in the
SAE. Please
submit a
follow-up SAE
form
[#2021187575]
to document if
COVID testing
was performed
(YES/NO or info
not available)
and if yes, the
date and results.
Feb-25-2021
13:49:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical - SAE
narrative reports
subject was
discharged on 10
medications;
please report
these to the SAE
Feb-24-2021
15:05:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-24-2021
12:19:50ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candida
teFor AE
myocardial
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957179
Page 182 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time
(US & Canada)infarction:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Feb-24-2021
12:19:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious e
vent associated
with congenital
anomaly or birt
h defect?
NO
Did this serious
event result in d
eath?
NO
Did this serious
event require or
prolong hospital
ization?
YES
Did this serious
event result in pInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957180
Page 183 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
ersistent or sign
ificant disability
/incapacity?
NO
Is this serious e
vent life threate
ning?
NO
Other medically
important seriou
s event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-24-2021
12:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-26-2021 ACV0PFEINFP6000 Query 1: Closed Response
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957181
Page 184 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
08:57:59
(UTC-05:00)
Eastern Time
(US & Canada)satisfies query.
Feb-25-2021
11:09:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to
study treatment(s)
, this event is due
to:
OTHER
If Other, specif
y:
unknown etio
logyTranscription
Error
Feb-25-2021
10:18:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Feb-25-2021
10:18:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
Feb-25-2021
02:59:17ACV0PFEINFP6000 Query 1: Opened DM: The
response for
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957182
Page 185 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time
(US & Canada)"Is this event
related to study
treatment" is
missing.
Kindly review
and update.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-24-2021
12:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-24-2021
12:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-24-2021
12:19:50
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957183
Page 186 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Eastern Time (US
& Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-24-2021
12:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-24-2021
12:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-24-2021
15:05:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2021187575Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957184
Page 187 of 206
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021
03:04:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies
query
Feb-17-2021
15:34:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Changed data
per query
Feb-16-2021
05:33:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly
consider to
update
missing
REVAX
CONF form
or else
clarify. Thank
you.
Feb-12-2021
12:00:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/15/2021Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957185
Page 188 of 206
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Not Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-12-2021
10:59:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing t
o return for Vaccinati
on 3
Participant is:
eligible per local/n
ational recommen
dations and confir
med to have receiv
ed only placebo at
Vaccination 1/2Transcription
Error
Feb-17-2021
15:34:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing t
o return for Vaccinati
on 3
Participant is:
eligible and NOT
confirmed to have
received only plac
ebo at Vaccination
1/2Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957186
Page 189 of 206
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-12-2021
11:51:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/15/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-12-2021
11:51:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957187
Page 190 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021
11:17:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/1/2021Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957188
Page 191 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Mar-12-2021
11:18:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent
Obtained
Mar/1/2021Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957189
Page 192 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-12-2021
11:19:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/1/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-12-2021
11:19:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Mar-12-2021
11:19:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957190
Page 193 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021
11:21:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021
11:21:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021
11:21:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-12-2021
11:21:00ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957191
Page 194 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-12-2021
11:21:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/1/2021Initial Entry
5.a
Date Location User Value Reason
Mar-12-2021
11:21:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRDWN
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021
11:21:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRDWNSInitial Entry
5.b
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957192
Page 195 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Mar-12-2021
11:21:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS3G4XInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-12-2021
11:21:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BS3G4XInitial Entry
5.c
Date Location User Value Reason
Mar-12-2021
11:21:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS3G4YInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957193
Page 196 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.c Sample ID
Date Location User Value Reason
Mar-12-2021
11:21:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BS3G4YInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957194
Page 197 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021
11:29:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021
11:29:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021
11:29:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-12-2021
11:29:25ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957195
Page 198 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-12-2021
11:29:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/1/2021Initial Entry
5.a
Date Location User Value Reason
Mar-12-2021
11:29:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRDWN
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021
11:29:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRDWNRInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957196
Page 199 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-12-2021
11:19:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-12-2021
11:19:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-12-2021
11:19:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957197
Page 200 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Mar-12-2021
11:19:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/1/2021 08:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-12-2021
11:19:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-12-2021
11:19:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Mar-12-2021
11:19:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957198
Page 201 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
8. Actual Dose:
Date Location User Value Reason
Mar-12-2021
11:19:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-12-2021
11:19:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-12-2021
11:19:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957199
Page 202 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Mar-12-2021
11:19:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957200
Page 203 of 206
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject Status
Date Location User Value Reason
Sep-30-2020
11:26:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-10-2020
08:48:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-10-2020
08:46:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-24-2021
15:03:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Cl
osedResponse satisfies query
Feb-24-2021 ACV0PFEINFP6000 Query 1: An data updated
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957201
Page 204 of 206
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
12:39:34
(UTC-05:00)
Eastern Time
(US & Canada)swered
Feb-24-2021
03:47:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Op
enedSAE
RECON:AER#2021187575
myocardial infarction(onset
date:28Oct2020)was
reported as serious in
Safety database but
missing in AE CRF. Please
confirm and update CRF. If
safety update is required,
submit a follow-up SAE
Form.
Oct-05-2020
12:09:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/25/2020Transcription Error
Sep-30-2020
11:26:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/28/202
0Initial Entry
Aug-10-2020
08:48:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/7/2020Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957202
Page 205 of 206
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-10-2020
08:46:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/7/2020Initial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957203
Page 206 of 206
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Aug-10-2020
09:16:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fda\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957204