Document text
Page 1 of 154
***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: 10821149 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
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957388
Page 2 of 154
***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: 10821149 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
Sep/3/2020
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957389
Page 3 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Demography
1.Subject ID [10821149]
2.Birth Date: /1967
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957390
Page 4 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/3/2020
2.Erroneous Visit
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957391
Page 5 of 154
***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: 10821149 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
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957392
Page 6 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957393
Page 7 of 154
***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: 10821149 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:[Presbyopia]
Start Date: UNK/UNK/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tonsillitis]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1999
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tonsillectomy]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1999
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[migraine headaches]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957394
Page 8 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hysterectomy]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[c5-c7 spinal fusion]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[kidney stones]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[percutaneous nephrolithotomy]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957395
Page 9 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[mild depression]
Start Date: UNK/UNK/2000
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Nicotine abuse]
Start Date: UNK/UNK/1985
Ongoing: YES
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957396
Page 10 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
2.Weight: [62.9]
3.Unit: kg
4.Height: [155.0]
5.Unit: cm
6.Body Mass Index: [26.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957397
Page 11 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/3/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957398
Page 12 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/3/2020
2.Randomization Number: [78011]
3.Randomization Group: [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957399
Page 13 of 154
***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: 10821149 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/3/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY6MV]
5.bSample ID [BPLDMS]
5.cSample ID [BPLDMT]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957400
Page 14 of 154
***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: 10821149 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:
Sep/3/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY6MT]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957401
Page 15 of 154
***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: 10821149 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: Sep/3/2020 13:27
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957402
Page 16 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957403
Page 17 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957404
Page 18 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957405
Page 19 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/23/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957406
Page 20 of 154
***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: 10821149 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:
Sep/23/2020
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 [BPY6T1]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957407
Page 21 of 154
***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: 10821149 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: Sep/23/2020 12:14
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957408
Page 22 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957409
Page 23 of 154
***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: 10821149 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:
Oct/21/2020
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 [BNTKPP]
5.bSample ID [BNTKPR]
5.cSample ID [BPY70Y]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957410
Page 24 of 154
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957411
Page 25 of 154
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 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 [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957412
Page 26 of 154
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957413
Page 27 of 154
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 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 [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957414
Page 28 of 154
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957415
Page 29 of 154
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 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 [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957416
Page 30 of 154
***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: 10821149 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:
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957417
Page 31 of 154
***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: 10821149 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: [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957418
Page 32 of 154
***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: 10821149 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 [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957419
Page 33 of 154
***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: 10821149 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 [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957420
Page 34 of 154
***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: 10821149 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?
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957421
Page 35 of 154
***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: 10821149 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:
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957422
Page 36 of 154
***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: 10821149 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:
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957423
Page 37 of 154
***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: 10821149 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 [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957424
Page 38 of 154
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957425
Page 39 of 154
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Unplanned Assessments
1.Assessments
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957426
Page 40 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957427
Page 41 of 154
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
:Nov/24/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957428
Page 42 of 154
***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: 10821149 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:
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957429
Page 43 of 154
***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: 10821149 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 [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957430
Page 44 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Malignant Melanoma (etiol
ogy unknown) Nov/24/2020 U
NK:UNK YES Repeating
Pages
2.ADVERSE E
VENT 2 neck pain Sep/21/2020 UN
K:UNK YES Repeating
Pages
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957431
Page 45 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 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)[Malignant Melanoma (etiology unknown)]
4.Start Date Time: Nov/24/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
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?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957432
Page 46 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
[etiology unknown]
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?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number:
For Pfizer Use Only[2020468170]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957433
Page 47 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[neck pain]
4.Start Date Time: Sep/21/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[previous neck injury]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957434
Page 48 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 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?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957435
Page 49 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957436
Page 50 of 154
***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: 10821149 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[ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957437
Page 51 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957438
Page 52 of 154
***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: 10821149 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: //
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957439
Page 53 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957440
Page 54 of 154
***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: 10821149 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?
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957441
Page 55 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957442
Page 56 of 154
***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: 10821149 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?
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957443
Page 57 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957444
Page 58 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957445
Page 59 of 154
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957446
Page 60 of 154
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 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:
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957447
Page 61 of 154
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957448
Page 62 of 154
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled 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: 10821149 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?
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957449
Page 63 of 154
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957450
Page 64 of 154
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957451
Page 65 of 154
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957452
Page 66 of 154
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957453
Page 67 of 154
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 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 [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957454
Page 68 of 154
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 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 [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957455
Page 69 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Applicable
//Comments
2.Erroneous Visit Not Applicable Comments
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957456
Page 70 of 154
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Not Applicable Comments
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957457
Page 71 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Applicable
//Comments
2.Primary Reason for Unblinding: Not Applicable Comments
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957458
Page 72 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957459
Page 73 of 154
***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: 10821149 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: [ ]
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957460
Page 74 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/24/2020
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957461
Page 75 of 154
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 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
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957462
Page 76 of 154
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 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
Name Signature
MeaningDate Type Action
William Smith Approved Feb-24-2021 10:55:18 (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.
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957463
Page 77 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormSep-03-2020 16:21:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957464
Page 78 of 154
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - Comments
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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormFeb-19-2021 14:37:15 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0957465
Page 79 of 154
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: DATE OF VISIT - Comments
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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Feb-19-2021 14:37:15 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0957466
Page 80 of 154
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: DATE OF VISIT - Comments
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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Feb-19-2021 14:37:15 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0957467
Page 81 of 154
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormFeb-19-2021 14:37:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0957468
Page 82 of 154
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Feb-19-2021 14:37:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0957469
Page 83 of 154
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormFeb-19-2021 14:36:54 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0957470
Page 84 of 154
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Feb-19-2021 14:36:54 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0957471
Page 85 of 154
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Feb-19-2021 14:36:54 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0957472
Page 86 of 154
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 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
Name Signature
MeaningDate Type Action
William Smith Approved Feb-24-2021 10:55:18 (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-19-2021 14:36:54 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William Smith Approved Jan-20-2021 14:48:25 (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 Nov-25-2020 13:17:36 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957473
Page 87 of 154
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
William Smith Approved Oct-27-2020 11:16:15 (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.
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957474
Page 88 of 154
***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: 10821149 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
Sep-03-2020 15:31:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-03-2020 15:31:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957475
Page 89 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-03-2020 15:32:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Sep/3/2020Initial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957476
Page 90 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-03-2020 15:31:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10821149Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-03-2020 15:31:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1967Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-03-2020 15:32:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-03-2020 15:32:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-03-2020 15:32:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957477
Page 91 of 154
***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: 10821149 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-03-2020 15:33:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957478
Page 92 of 154
***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: 10821149 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
Sep-03-2020 15:33:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-03-2020 15:33:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-03-2020 15:33:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957479
Page 93 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.a
Date Location User Value Reason
Sep-03-2020 15:55:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Presbyopia
Start Date: UNK/UNK/2
020
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:55:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 15:55:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PresbyopiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-04-2020 01:33:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed by DM:
Sep-03-2020 17:43:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered confirmed, event
began prior to
signing ICF
Sep-03-2020 17:30:46
(UTC-05:00) EasternACV0PFEINFP6000 Query 1: Reissued:Opened DM Requery:
Please confirm the
090177e196ae3fd8\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)
(b) (6)
FDA-CBER-2021-5683-0957480
Page 94 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada) event happened
before the patient
signed the
Informed Consent
document.
Sep-03-2020 15:56:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Start date is
unknown but is
confirmed before
vaccination.
Sep-03-2020 15:55:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after
or equal to the first
vaccination date
03/Sep/2020.
Please review and
update as
appropriate.
Sep-03-2020 15:55:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-03-2020 15:55:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-03-2020 15:58:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:tonsillitis
Start Date: UNK/UNK/1
999Transcription Error
090177e196ae3fd8\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-2021-5683-0957481
Page 95 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Ongoing: NO
End Date:
UNK/UN
K/1999
Sep-03-2020 15:57:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:tonsillitis
Start Date: UNK/UNK/1
980
Ongoing: NO
End Date:
UNK/UN
K/1980Initial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957482
Page 96 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.b Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:57:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 15:57:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
tonsillitisInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-03-2020 15:58:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1999Transcription Error
Sep-03-2020 15:57:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-03-2020 15:58:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1999Transcription Error
Sep-03-2020 15:57:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1980Initial Entry
1.c
Date Location User Value Reason
090177e196ae3fd8\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957483
Page 97 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-03-2020 15:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:tonsillectomy
Start Date: UNK/UNK/19
99
Ongoing: NO
End Date:
UNK/UNK/
1999Initial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957484
Page 98 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.c Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 15:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
tonsillectomyInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-03-2020 15:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1999Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-03-2020 15:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1999Initial Entry
1.d
Date Location User Value Reason
Sep-03-2020 15:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:migraine head
aches
Start Date: UNK/UNK/20
05
Ongoing: YESInitial Entry
090177e196ae3fd8\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-2021-5683-0957485
Page 99 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.d Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 15:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
migraine headachesInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-03-2020 15:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-03-2020 15:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-03-2020 15:59:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:hysterectomy
Start Date: UNK/UNK/20
05Initial Entry
090177e196ae3fd8\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-2021-5683-0957486
Page 100 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Ongoing: NO
End Date:
UNK/UNK/
2005
1.e Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:59:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 15:59:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hysterectomyInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-03-2020 15:59:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-03-2020 15:59:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.f
Date Location User Value Reason
Sep-03-2020 16:00:04
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb 6Initial Entry
090177e196ae3fd8\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-2021-5683-0957487
Page 101 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada) er:
Medical History
Term:c5-c7 spinal fu
sion
Start Date: UNK/UNK/20
19
Ongoing: NO
End Date:
UNK/UNK/
2019
1.f Line/MH Number:
Date Location User Value Reason
Sep-03-2020 16:00:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 16:00:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
c5-c7 spinal fusionInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-03-2020 16:00:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-03-2020 16:00:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
090177e196ae3fd8\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-2021-5683-0957488
Page 102 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.g
Date Location User Value Reason
Sep-03-2020 16:00:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7
Medical History
Term:kidney stones
Start Date: UNK/UNK/20
07
Ongoing: NO
End Date:
UNK/UNK/
2007Initial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957489
Page 103 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.g Line/MH Number:
Date Location User Value Reason
Sep-03-2020 16:00:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 16:00:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kidney stonesInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-03-2020 16:00:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2007Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-03-2020 16:00:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2007Initial Entry
1.h
Date Location User Value Reason
Sep-03-2020 16:01:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:percutaneous neph
rolithotomy
Start Date: UNK/UNK/2007Initial Entry
090177e196ae3fd8\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-2021-5683-0957490
Page 104 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Ongoing: NO
End Date:
UNK/UNK/20
07
1.h Line/MH Number:
Date Location User Value Reason
Sep-03-2020 16:01:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 16:01:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
percutaneous nephrolithotomyInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-03-2020 16:01:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2007Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-03-2020 16:01:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2007Initial Entry
1.i
Date Location User Value Reason
Sep-03-2020 16:01:30
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number 9Initial Entry
090177e196ae3fd8\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-2021-5683-0957491
Page 105 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada) :
Medical History T
erm:mild depressi
on
Start Date: UNK/UNK/2
000
Ongoing: YES
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957492
Page 106 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.i Line/MH Number:
Date Location User Value Reason
Sep-03-2020 16:01:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 16:01:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
mild depressionInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-03-2020 16:01:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-03-2020 16:01:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Sep-03-2020 16:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:10
Medical History T
erm:Nicotine abu
se
Start Date: UNK/UNK/1
985
Ongoing: YESInitial Entry
090177e196ae3fd8\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-2021-5683-0957493
Page 107 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.j Line/MH Number:
Date Location User Value Reason
Sep-03-2020 16:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 16:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nicotine abuseInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-03-2020 16:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-03-2020 16:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fd8\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-2021-5683-0957494
Page 108 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Sep-03-2020 15:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-03-2020 15:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
62.9Initial Entry
3. Unit:
Date Location User Value Reason
Sep-03-2020 15:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-03-2020 15:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
155.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-03-2020 15:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3fd8\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957495
Page 109 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-03-2020 15:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
26.2Initial Entry
7.a
Date Location User Value Reason
Sep-03-2020 15:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 36.6
Temperature Un
it:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-03-2020 15:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-03-2020 15:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-03-2020 15:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3fd8\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-2021-5683-0957496
Page 110 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-03-2020 15:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957497
Page 111 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-03-2020 15:49:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-03-2020 15:49:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-03-2020 15:49:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-03-2020 15:49:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-03-2020 15:49:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957498
Page 112 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-03-2020 15:49:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-03-2020 15:49:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-03-2020 15:49:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-03-2020 15:49:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957499
Page 113 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-03-2020 15:52:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-03-2020 15:52:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
78011Initial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957500
Page 114 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 15:53:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 15:53:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 15:54:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 15:53:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-03-2020 15:53:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957501
Page 115 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-03-2020 15:54:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY6MVInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 15:54:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY6MVInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020 15:54:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLDMSInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-03-2020 15:54:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPLDMSInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020 15:54:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLDMTInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-03-2020 15:54:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPLDMTInitial Entry
090177e196ae3fd8\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),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957502
Page 116 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 15:53:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 15:53:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 15:53:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 15:53:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-03-2020 15:53:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957503
Page 117 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-03-2020 15:53:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY6MTInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 15:53:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY6MTInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957504
Page 118 of 154
***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: 10821149 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
Sep-03-2020 15:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 15:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020 15:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-03-2020 15:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 13:27Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020 15:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957505
Page 119 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-03-2020 15:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-03-2020 15:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-03-2020 15:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-03-2020 15:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957506
Page 120 of 154
***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: 10821149 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
Sep-03-2020 16:36:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTTranscription Error
Sep-03-2020 15:55:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E
-DIARY COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957507
Page 121 of 154
***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: 10821149 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-24-2020 15:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957508
Page 122 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020 15:53:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-24-2020 15:53:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 37.1
Temperature Unit
:C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-24-2020 15:53:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-24-2020 15:53:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
37.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-24-2020 15:53:41
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae3fd8\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957509
Page 123 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
2.a Temperature Location:
Date Location User Value Reason
Sep-24-2020 15:53:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0957510
Page 124 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-24-2020 15:57:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-24-2020 15:57:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-24-2020 15:57:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-24-2020 15:57:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-24-2020 15:57:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957511
Page 125 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-24-2020 15:57:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-24-2020 15:57:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-24-2020 15:57:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-24-2020 15:57:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957512
Page 126 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 15:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 15:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020 15:59:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-24-2020 15:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-24-2020 15:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020 15:59:09
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Sample ID: BPY6T1Initial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0957513
Page 127 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Sep-24-2020 15:59:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY6T1Initial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0957514
Page 128 of 154
***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: 10821149 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
Sep-24-2020 16:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020 16:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020 16:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-24-2020 16:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020 12:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020 16:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957515
Page 129 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-24-2020 16:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-24-2020 16:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-24-2020 16:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-24-2020 16:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957516
Page 130 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-21-2020 13:30:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957517
Page 131 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 10:34:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 10:34:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 10:35:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 10:34:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-22-2020 10:34:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020 10:35:20
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Sample ID: BNTKPPInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0957518
Page 132 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 10:35:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNTKPPInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020 10:35:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNTKPRInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020 10:35:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNTKPRInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020 10:36:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY70YInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020 10:36:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY70YInitial Entry
090177e196ae3fd8\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),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0957519
Page 133 of 154
***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: 10821149 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-22-2020 11:52:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-22-2020 11:52:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-22-2020 11:52:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957520
Page 134 of 154
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 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
Dec-01-2020 06:55:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-01-2020 06:55:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/24/2020Transcription Error
Dec-01-2020 06:55:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "Date of
Completion/Discontinuation
/Death" 24/Dec/2020 is a
future date relative to when
it was entered on 01/Dec
/2020. Please correct.
Dec-01-2020 06:55:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-01-2020 06:55:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Dec-01-2020 06:55:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-01-2020 06:55:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to
"Status" is
ADVERSE
EVENT but
"Specify Status" is
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0957521
Page 135 of 154
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Provided.
Dec-01-2020 06:55:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTInitial Entry
4. Specify Status:
Date Location User Value Reason
Dec-01-2020 06:55:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Dec-01-2020 06:55:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
subject withdrew consent due to
AEInitial Entry
090177e196ae3fd8\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-2021-5683-0957522
Page 136 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Date Location User Value Reason
Nov-25-2020 13:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957523
Page 137 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Date Location User Value Reason
Dec-01-2020 11:46:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957524
Page 138 of 154
***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
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-25-2020 13:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-25-2020 13:17:36
(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
Nov-30-2020 09:44:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Malignant Melanoma (etiology
unknown)Transcription Error
Nov-25-2020 13:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Malignant MelanomaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-10-2020 09:51:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-07-2020 12:28:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Dec-06-2020 12:16:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL SAE
has been revised to
Med Important and
not Life
090177e196ae3fd8\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957525
Page 139 of 154
***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
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Threatening. In this
setting, please
review severity
grade of 4.
Nov-25-2020 13:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-02-2020 01:28:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-01-2020 06:57:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered confirmed AE
continues.
Follow-up form
was completed per
issued query since
subject
discontinued study.
Dec-01-2020 06:55:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is
still ongoing.
Please review and
update as
appropriate.
Nov-25-2020 13:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-07-2020 12:28:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3New Information
090177e196ae3fd8\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957526
Page 140 of 154
***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
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Dec-01-2020 18:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-30-2020 09:44:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered site awaiting
receipt of medical
records
Nov-30-2020 01:11:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL please
describe location,
size and TNM
stage of malignant
melanoma, as basis
for Toxicity grade
4
Nov-25-2020 13:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-01-2020 18:57:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Dec-01-2020 05:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-30-2020 09:44:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Malignant
Melanoma
(etiology
unknown):
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
090177e196ae3fd8\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957527
Page 141 of 154
***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
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Adverse Event
Number" is blank.
Nov-30-2020 09:40:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered SAE reporting to
be updated. Event
is not considered to
be life threatening.
Nov-30-2020 02:54:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL - SAE
criterion is
Medically
Important;
however, SAE
report criteria are
Medically
Important and Life
Threatening. Please
review, harmonize
reporting, and
update in the
correct location.
Nov-30-2020 01:09:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Candidate CLINICAL - SAE
criterion is
Medically
Important;
however, SAE
report criteria are
Medically
Important and Life
Threatening. Please
review, harmonize
reporting, and
update in the
correct location.
Nov-25-2020 13:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Malignant
Melanoma:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
090177e196ae3fd8\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-2021-5683-0957528
Page 142 of 154
***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
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Nov-25-2020 13:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
NO
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life threa
tening?
NO
Other medically important se
rious event
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-25-2020 13:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957529
Page 143 of 154
***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
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Dec-01-2020 18:58:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-30-2020 09:44:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-30-2020 09:44:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
etiology unknownTranscription Error
Nov-30-2020 01:06:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL Please
clarify the
concomitant
non-drug treatment
felt to be related in
a causal way to
malignant
melanoma
Nov-25-2020 13:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
CONCOMITANT NON-D
RUG TREATMENTInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-25-2020 13:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3fd8\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957530
Page 144 of 154
***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
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-25-2020 13:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-25-2020 13:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-25-2020 13:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-01-2020 10:26:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Dec-01-2020 06:55:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered data updated
Nov-30-2020 15:18:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Reissued:Opened CLINQUERY: If
entry is correct, and
event led to end of
study, please
complete the FUP
tab
Nov-30-2020 09:50:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered data updated
090177e196ae3fd8\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),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0957531
Page 145 of 154
***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
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Nov-26-2020 08:39:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY:
Event is reported to
have led to
discontinuation
from study.
However, FUP tab
is not complete to
match to end of
study. Please review
and update as
appropriate
Nov-25-2020 13:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-01-2020 05:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020468170Initial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0957532
Page 146 of 154
***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
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Category:
Date Location User Value Reason
Dec-01-2020 11:46:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-01-2020 11:46:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-01-2020 11:46:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
neck painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-01-2020 11:46:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-02-2020 01:29:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-01-2020 11:46:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered data confirmed
090177e196ae3fd8\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-2021-5683-0957533
Page 147 of 154
***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
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Dec-01-2020 11:46:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is
still ongoing. Please
review and update
as appropriate.
Dec-01-2020 11:46:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-01-2020 11:46:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-01-2020 11:46:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-01-2020 11:46:16
(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
090177e196ae3fd8\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-2021-5683-0957534
Page 148 of 154
***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
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Dec-01-2020 11:46:16
(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, specify:
previous neck injuryInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-01-2020 11:46:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-01-2020 11:46:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-01-2020 11:46:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-01-2020 11:46:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3fd8\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957535
Page 149 of 154
***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
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Dec-01-2020 11:46:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957536
Page 150 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User ValueReason
Feb-22-2021
15:08:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Rivkah Rosen Query
1: Clo
sedResponse satisfies
query
Feb-22-2021
12:50:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dsubject withdrew
from study prior to
the unblinding
Feb-22-2021
01:11:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7331110;Date
of Visit is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or
clarify
Feb-19-2021
14:37:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Feb-19-2021 14:37:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0957537
Page 151 of 154
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 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
Feb-19-2021 14:37:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957538
Page 152 of 154
***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: 10821149 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-19-2021 14:36:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-19-2021 14:36:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957539
Page 153 of 154
***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: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-01-2020 06:55:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-22-2020 11:52:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-03-2020 15:52:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-03-2020 15:33:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-01-2020 06:55:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/24/2020Transcription Error
Dec-01-2020 06:55:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/24/2020Initial Entry
Oct-22-2020 11:52:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
Sep-03-2020 15:52:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/3/2020Initial Entry
Sep-03-2020 15:33:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/3/2020Initial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957540
Page 154 of 154
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research -
Knoxville
Subject No: 10821149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-25-2020 10:41:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fd8\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957541