Document text
Page 1 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816973
Page 2 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/4/2020
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816974
Page 3 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11781107]
2.Birth Date: /1972
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:
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0816975
Page 4 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816976
Page 5 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816977
Page 6 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816978
Page 7 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergies]
Start Date: UNK/UNK/1977
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[benign paroxysmal vertigo]
Start Date: UNK/UNK/1998
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sinus headache]
Start Date: UNK/UNK/1977
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[uterine fibroids]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2005
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816979
Page 8 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hysterctomy]
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:[menorrhagia]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2005
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[eczema]
Start Date: UNK/UNK/2017
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteoarthritis, bilateral knees and feet]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816980
Page 9 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[pitocin allergy]
Start Date: UNK/UNK/1998
Ongoing: YES
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816981
Page 10 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
2.Weight: [250.0]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [36.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816982
Page 11 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816983
Page 12 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/4/2020
2.Randomization Number: [82074]
3.Randomization Group: [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816984
Page 13 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BPY8G4]
5.bSample ID [BNWP3N]
5.cSample ID [BNWP3P]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816985
Page 14 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BPY8G3]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816986
Page 15 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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/4/2020 13:38
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
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816987
Page 16 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816988
Page 17 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816989
Page 18 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816990
Page 19 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816991
Page 20 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW3K1]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816992
Page 21 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Applicable Comments
2.Treatment Name Not Applicable
[ ]Comments
3.Formulation: Not Applicable Comments
4.Dose Date Time: Not Applicable
//Comments
5.Anatomical Location: Not Applicable Comments
6.Body Side: Not Applicable Comments
7.Route: Not Applicable Comments
8.Actual Dose: Not Applicable
[ ]Comments
9.Unit: Not Applicable Comments
10.Timeframe Subject Was Observed Not Applicable Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Applicable Comments
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816993
Page 22 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/23/2020
2.Erroneous Visit
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816994
Page 23 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/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 [BPW3ZT]
5.bSample ID [BRVDY7]
5.cSample ID [BRVDY8]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816995
Page 24 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816996
Page 25 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816997
Page 26 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816998
Page 27 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816999
Page 28 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817000
Page 29 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817001
Page 30 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817002
Page 31 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817003
Page 32 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817004
Page 33 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817005
Page 34 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817006
Page 35 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817007
Page 36 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817008
Page 37 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817009
Page 38 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817010
Page 39 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unplanned Assessments
1.Assessments
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817011
Page 40 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Sep/25/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817012
Page 41 of 185
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817013
Page 42 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817014
Page 43 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817015
Page 44 of 185
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 injection site redness Sep/4/2020 19:00 NO
End Date Time:
Sep/5/2020 19:00
Repeating
Pages
2.ADVERSE EV
ENT 2 injection site warmth Sep/4/2020 19:00 NO
End Date Time:
Sep/5/2020 19:00
Repeating
Pages
3.ADVERSE EV
ENT 3 chills Sep/5/2020 18:00 NO
End Date Time:
Sep/5/2020 20:00
Repeating
Pages
4.ADVERSE EV
ENT 4 injection site muscle s
oreness Sep/4/2020 19:00 NO
End Date Time:
Sep/6/2020 UNK:UNK
Repeating
Pages
5.ADVERSE EV
ENT 5 right axilla lymphaden
opathy Sep/16/2020 UNK
:UNK NO
End Date Time:
Nov/20/2020 UNK:UN
K
Repeating
Pages
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817016
Page 45 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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)[injection site redness]
4.Start Date Time: Sep/4/2020 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/5/2020 19:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817017
Page 46 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817018
Page 47 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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)[injection site warmth]
4.Start Date Time: Sep/4/2020 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/5/2020 19:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817019
Page 48 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817020
Page 49 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[chills]
4.Start Date Time: Sep/5/2020 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/5/2020 20:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817021
Page 50 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817022
Page 51 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[injection site muscle soreness]
4.Start Date Time: Sep/4/2020 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/6/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817023
Page 52 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817024
Page 53 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[right axilla lymphadenopathy]
4.Start Date Time: Sep/16/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/20/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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
9.Is this event related to study
treatment:RELATED
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817025
Page 54 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020365378]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817026
Page 55 of 185
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817027
Page 56 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817028
Page 57 of 185
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817029
Page 58 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: //
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817030
Page 59 of 185
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817031
Page 60 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817032
Page 61 of 185
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817033
Page 62 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817034
Page 63 of 185
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817035
Page 64 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817036
Page 65 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817037
Page 66 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817038
Page 67 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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:
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817039
Page 68 of 185
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817040
Page 69 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817041
Page 70 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817042
Page 71 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817043
Page 72 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817044
Page 73 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817045
Page 74 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817046
Page 75 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817047
Page 76 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817048
Page 77 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/18/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817049
Page 78 of 185
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817050
Page 79 of 185
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817051
Page 80 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/25/2020
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817052
Page 81 of 185
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817053
Page 82 of 185
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817054
Page 83 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-04-2020 14:24:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817055
Page 84 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-04-2020 14:29:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817056
Page 85 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-04-2020 14:29:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817057
Page 86 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Sep-04-2020 14:29:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817058
Page 87 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Sep-04-2020 14:29:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817059
Page 88 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Sep-04-2020 14:29:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817060
Page 89 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Sep-04-2020 14:29:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817061
Page 90 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aSep-04-2020 14:29:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817062
Page 91 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aSep-04-2020 14:29:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817063
Page 92 of 185
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aSep-04-2020 14:29:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817064
Page 93 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-25-2020 12:13:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817065
Page 94 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-25-2020 12:13:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817066
Page 95 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Sep-25-2020 12:13:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817067
Page 96 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Sep-25-2020 12:13:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817068
Page 97 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Sep-25-2020 12:13:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817069
Page 98 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Sep-25-2020 12:13:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817070
Page 99 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aSep-25-2020 12:13:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817071
Page 100 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aSep-25-2020 12:13:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817072
Page 101 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aSep-25-2020 12:13:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817073
Page 102 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-25-2020 12:04:04 (UTC-06:00) Central
Time (US & Canada)Subject withdrew from study treatment. Will
continue with follow up visits.
Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817074
Page 103 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-25-2020 12:04:04 (UTC-06:00) Central
Time (US & Canada)Subject withdrew from study treatment. Will
continue with follow up visits.
Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817075
Page 104 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Sep-25-2020 12:04:04 (UTC-06:00) Central
Time (US & Canada)Subject withdrew from study treatment. Will
continue with follow up visits.
Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817076
Page 105 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Sep-25-2020 12:04:04 (UTC-06:00) Central
Time (US & Canada)Subject withdrew from study treatment. Will
continue with follow up visits.
Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817077
Page 106 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Sep-25-2020 12:04:04 (UTC-06:00) Central
Time (US & Canada)Subject withdrew from study treatment. Will
continue with follow up visits.
Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817078
Page 107 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Sep-25-2020 12:04:04 (UTC-06:00) Central
Time (US & Canada)Subject withdrew from study treatment. Will
continue with follow up visits.
Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817079
Page 108 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Sep-25-2020 12:04:04 (UTC-06:00) Central
Time (US & Canada)Subject withdrew from study treatment. Will
continue with follow up visits.
Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817080
Page 109 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Sep-25-2020 12:04:04 (UTC-06:00) Central
Time (US & Canada)Subject withdrew from study treatment. Will
continue with follow up visits.
Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817081
Page 110 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Sep-25-2020 12:04:04 (UTC-06:00) Central
Time (US & Canada)Subject withdrew from study treatment. Will
continue with follow up visits.
Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817082
Page 111 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
9Sep-25-2020 12:04:04 (UTC-06:00) Central
Time (US & Canada)Subject withdrew from study treatment. Will
continue with follow up visits.
Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817083
Page 112 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
10Sep-25-2020 12:04:04 (UTC-06:00) Central
Time (US & Canada)Subject withdrew from study treatment. Will
continue with follow up visits.
Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817084
Page 113 of 185
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
11Sep-25-2020 12:04:04 (UTC-06:00) Central
Time (US & Canada)Subject withdrew from study treatment. Will
continue with follow up visits.
Not Applicable
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0817085
Page 114 of 185
***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, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Jan-26-2021 14:38:32 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephan Sharp Approved Jan-20-2021 11:15:02 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephanSharp, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-14-2020 10:26:52 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephan Sharp Approved Oct-27-2020 09:41:46 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephanSharp, 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.
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817086
Page 115 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-04-2020 14:23:39
(UTC-06:00) Central
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-04-2020 14:23:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817087
Page 116 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-04-2020 14:23:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/4/2020Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817088
Page 117 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-04-2020 14:23:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11781107Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-04-2020 14:23:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1972Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-04-2020 14:24:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-04-2020 14:24:21
(UTC-06:00) Central
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-04-2020 14:24:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817089
Page 118 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-04-2020 14:24:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817090
Page 119 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-04-2020 14:24:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-04-2020 14:24:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-04-2020 14:24:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817091
Page 120 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.a
Date Location User Value Reason
Sep-04-2020 14:25:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:seasonal aller
gies
Start Date: UNK/UNK/1
977
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-04-2020 14:25:08
(UTC-06:00) Central
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-04-2020 14:25:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
seasonal allergiesInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-04-2020 14:25:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1977Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-04-2020 14:25:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817092
Page 121 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-04-2020 14:26:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:benign paroxysm
al vertigo
Start Date: UNK/UNK/1998
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-04-2020 14:26:00
(UTC-06:00) Central
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-04-2020 14:26:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
benign paroxysmal vertigoInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-04-2020 14:26:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-04-2020 14:26:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-04-2020 14:26:15
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817093
Page 122 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada) Medical History T
erm:sinus headach
e
Start Date: UNK/UNK/1
977
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-04-2020 14:26:15
(UTC-06:00) Central
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-04-2020 14:26:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
sinus headacheInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-04-2020 14:26:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1977Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-04-2020 14:26:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-04-2020 14:26:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:uterine fibroidsInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817094
Page 123 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Start Date: UNK/UNK/200
3
Ongoing: NO
End Date:
UNK/UNK/
2005
1.d Line/MH Number:
Date Location User Value Reason
Sep-04-2020 14:26:35
(UTC-06:00) Central
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-04-2020 14:26:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
uterine fibroidsInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-04-2020 14:26:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2003Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-04-2020 14:26:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.e
Date Location User Value Reason
Sep-04-2020 14:26:59
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe 5Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817095
Page 124 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada) r:
Medical History
Term:hysterctomy
Start Date: UNK/UNK/200
5
Ongoing: NO
End Date:
UNK/UNK/
2005
1.e Line/MH Number:
Date Location User Value Reason
Sep-04-2020 14:26:59
(UTC-06:00) Central
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-04-2020 14:26:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hysterctomyInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-04-2020 14:26:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-04-2020 14:26:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.f
Date Location User Value Reason
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817096
Page 125 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-04-2020 14:27:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:menorrhagia
Start Date: UNK/UNK/200
3
Ongoing: NO
End Date:
UNK/UNK/
2005Initial Entry
1.f Line/MH Number:
Date Location User Value Reason
Sep-04-2020 14:27:49
(UTC-06:00) Central
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-04-2020 14:27:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
menorrhagiaInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-04-2020 14:27:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2003Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-04-2020 14:27:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817097
Page 126 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.g
Date Location User Value Reason
Sep-04-2020 14:28:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History T
erm:eczema
Start Date: UNK/UNK/2
017
Ongoing: YESInitial Entry
1.g Line/MH Number:
Date Location User Value Reason
Sep-04-2020 14:28:09
(UTC-06:00) Central
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-04-2020 14:28:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
eczemaInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-04-2020 14:28:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-04-2020 14:28:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817098
Page 127 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-04-2020 14:28:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:osteoarthritis, bilater
al knees and feet
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
1.h Line/MH Number:
Date Location User Value Reason
Sep-04-2020 14:28:35
(UTC-06:00) Central
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-04-2020 14:28:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
osteoarthritis, bilateral knees and f
eetInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-04-2020 14:28:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-04-2020 14:28:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-04-2020 14:29:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817099
Page 128 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Medical History T
erm:pitocin allerg
y
Start Date: UNK/UNK/1
998
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Sep-04-2020 14:29:04
(UTC-06:00) Central
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-04-2020 14:29:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
pitocin allergyInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-04-2020 14:29:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-04-2020 14:29:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817100
Page 129 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020 14:29:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-04-2020 14:29:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
250.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-04-2020 14:29:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-04-2020 14:29:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-04-2020 14:29:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-04-2020 14:29:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
36.9Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817101
Page 130 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7.a
Date Location User Value Reason
Sep-04-2020 14:29:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.8
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-04-2020 14:29:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-04-2020 14:29:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.8Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-04-2020 14:29:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-04-2020 14:29:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817102
Page 131 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-04-2020 14:29:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-04-2020 14:29:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-04-2020 14:29:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-04-2020 14:29:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-04-2020 14:29:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-04-2020 14:29:53
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817103
Page 132 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada) Sponsor-Defined Id
entifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
able
6.a Sponsor ID:
Date Location User Value Reason
Sep-04-2020 14:29:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-04-2020 14:29:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-04-2020 14:29:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-04-2020 14:29:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817104
Page 133 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-04-2020 14:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-04-2020 14:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
82074Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817105
Page 134 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 14:34:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 14:34:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020 14:34:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 14:34:29
(UTC-06:00) Central
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-04-2020 14:34:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 14:34:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY8G4Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817106
Page 135 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 14:34:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY8G4Initial Entry
5.b
Date Location User Value Reason
Sep-04-2020 14:34:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWP3NInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-04-2020 14:34:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWP3NInitial Entry
5.c
Date Location User Value Reason
Sep-04-2020 14:35:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWP3PInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-04-2020 14:35:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWP3PInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817107
Page 136 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 14:34:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 14:34:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020 14:34:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 14:34:05
(UTC-06:00) Central
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-04-2020 14:34:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 14:34:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY8G3Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817108
Page 137 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 14:34:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY8G3Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817109
Page 138 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-04-2020 14:30:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020 14:30:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020 14:30:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-04-2020 14:30:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020 13:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020 14:30:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-04-2020 14:30:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817110
Page 139 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7. Route:
Date Location User Value Reason
Sep-04-2020 14:30:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-04-2020 14:30:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-04-2020 14:30:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817111
Page 140 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-04-2020 14:31:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817112
Page 141 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-25-2020 12:12:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817113
Page 142 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020 12:12:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2.a
Date Location User Value Reason
Sep-25-2020 12:12:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 97.3
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-25-2020 12:12:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-25-2020 12:12:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-25-2020 12:12:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817114
Page 143 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-25-2020 12:12:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817115
Page 144 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-25-2020 12:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-25-2020 12:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-25-2020 12:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-25-2020 12:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-25-2020 12:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-25-2020 12:13:06
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817116
Page 145 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada) Sponsor-Defined Id
entifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
able
6.a Sponsor ID:
Date Location User Value Reason
Sep-25-2020 12:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-25-2020 12:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-25-2020 12:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-25-2020 12:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817117
Page 146 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 11:00:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 11:00:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020 11:00:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-25-2020 11:00:27
(UTC-06:00) Central
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-25-2020 11:00:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020 11:00:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW3K1Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817118
Page 147 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Sep-25-2020 11:00:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPW3K1Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817119
Page 148 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-25-2020 12:04:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020 12:04:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020 12:04:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-25-2020 12:04:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020 12:04:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-25-2020 12:04:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817120
Page 149 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7. Route:
Date Location User Value Reason
Sep-25-2020 12:04:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
8. Actual Dose:
Date Location User Value Reason
Sep-25-2020 12:04:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
9. Unit:
Date Location User Value Reason
Sep-25-2020 12:04:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-25-2020 12:04:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-25-2020 12:04:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817121
Page 150 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-23-2020 11:18:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/23/2020Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817122
Page 151 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-23-2020 11:19:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-23-2020 11:19:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-23-2020 11:19:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-23-2020 11:19:08
(UTC-06:00) Central
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-23-2020 11:19:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/23/2020Initial Entry
5.a
Date Location User Value Reason
Oct-23-2020 11:19:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW3ZTInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817123
Page 152 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Oct-23-2020 11:19:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPW3ZTInitial Entry
5.b
Date Location User Value Reason
Oct-23-2020 11:19:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRVDY7Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-23-2020 11:19:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRVDY7Initial Entry
5.c
Date Location User Value Reason
Oct-23-2020 11:19:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRVDY8Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-23-2020 11:19:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRVDY8Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817124
Page 153 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-25-2020 12:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-25-2020 12:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-26-2020 06:00:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-25-2020 12:11:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject withdrew
from study
intervention only.
Will continue with
follow up visits.
Sep-25-2020 12:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from
the study' reported
as YES. Please
check and correct
the data.
Sep-25-2020 12:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817125
Page 154 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Sep-14-2020 09:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817126
Page 155 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Sep-14-2020 09:06:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817127
Page 156 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Sep-14-2020 09:11:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817128
Page 157 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Sep-14-2020 09:14:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817129
Page 158 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Sep-21-2020 17:10:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817130
Page 159 of 185
***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, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Sep-14-2020 09:03:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-14-2020 09:03:39
(UTC-06:00) Central
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
Sep-14-2020 09:03:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
injection site rednessInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-14-2020 09:03:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020 19:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-14-2020 09:03:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/5/2020 19:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817131
Page 160 of 185
***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, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-14-2020 09:03:39
(UTC-06:00) Central
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
Sep-14-2020 09:03:39
(UTC-06:00) Central
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
Sep-14-2020 09:03:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-14-2020 09:03:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-14-2020 09:03:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-14-2020 09:03:39
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817132
Page 161 of 185
***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, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-14-2020 09:03:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-14-2020 09:03:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-14-2020 09:03:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817133
Page 162 of 185
***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, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Sep-14-2020 09:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-14-2020 09:06:54
(UTC-06:00) Central
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
Sep-14-2020 09:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
injection site warmthInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-14-2020 09:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020 19:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-14-2020 09:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/5/2020 19:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817134
Page 163 of 185
***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, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-14-2020 09:06:54
(UTC-06:00) Central
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
Sep-14-2020 09:06:54
(UTC-06:00) Central
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
Sep-14-2020 09:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-14-2020 09:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-14-2020 09:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-14-2020 09:06:54
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817135
Page 164 of 185
***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, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-14-2020 09:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-14-2020 09:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-14-2020 09:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817136
Page 165 of 185
***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, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Sep-14-2020 09:11:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-14-2020 09:11:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-14-2020 09:11:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
chillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-14-2020 09:11:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/5/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-14-2020 09:11:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/5/2020 20:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817137
Page 166 of 185
***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, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-14-2020 09:11:21
(UTC-06:00) Central
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
Sep-14-2020 09:11:21
(UTC-06:00) Central
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
Sep-14-2020 09:11:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-14-2020 09:11:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-14-2020 09:11:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-14-2020 09:11:21
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817138
Page 167 of 185
***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, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-14-2020 09:11:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-14-2020 09:11:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-14-2020 09:11:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817139
Page 168 of 185
***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, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Sep-14-2020 09:14:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-14-2020 09:14:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-14-2020 09:14:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
injection site muscle sorenessInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-14-2020 10:20:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-14-2020 10:20:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020 19:00Transcription Error
Sep-14-2020 09:14:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE injection site
muscle soreness:
Start Date is the
same as a
Vaccination Date,
but time is not
provided. Please
review and update as
appropriate.
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817140
Page 169 of 185
***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, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-14-2020 09:14:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-14-2020 09:15:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/6/2020 UNK:UNKTranscription Error
Sep-14-2020 09:14:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-14-2020 09:14:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-14-2020 09:14:41
(UTC-06:00) Central
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
Sep-14-2020 09:14:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817141
Page 170 of 185
***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, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-14-2020 09:14:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-14-2020 09:14:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-14-2020 09:14:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-14-2020 09:14:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-14-2020 09:15:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-14-2020 09:14:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE injection site
muscle soreness: Response
to "What was the outcome
of this adverse event?" is
RECOVERED/RESOLVED
but End Date/Time is
missing.
Sep-14-2020 09:14:41
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817142
Page 171 of 185
***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, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada)
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-14-2020 09:14:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817143
Page 172 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Sep-21-2020 17:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-21-2020 17:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-21-2020 17:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
right axilla lymphadenopathyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-21-2020 17:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-14-2020 10:41:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 2: Closed Response satisfies
query
Dec-14-2020 10:26:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New Information
Dec-14-2020 10:26:52
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
NONew Information
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0817144
Page 173 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada) End Date Time:
Nov/20/2020 UNK:UNK
Dec-11-2020 09:22:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 2: Opened CLINQUERY: Please
review and confirm if
this AE of 'right
axilla
lymphadenopathy'
remains ongoing, or
if any change to
status
Nov-02-2020 09:06:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Closed Response satisfies
query
Nov-02-2020 08:26:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered ongoing
Nov-02-2020 06:10:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Opened CLINQUERY: Please
review if this event
remains ongoing and
provide an update on
condition
Sep-21-2020 17:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-21-2020 17:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0817145
Page 174 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-22-2020 05:13:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-21-2020 17:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE right axilla
lymphadenopathy:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Sep-21-2020 17:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
YESInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817146
Page 175 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
Sep-21-2020 17:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-21-2020 17:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-25-2020 12:09:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNChanged
Information
Sep-21-2020 17:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-25-2020 12:10:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESChanged
Information
Sep-21-2020 17:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-21-2020 17:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817147
Page 176 of 185
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-14-2020 10:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-14-2020 10:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Dec-14-2020 10:26:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE right axilla
lymphadenopathy:
Response to "What
was the outcome of
this adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Sep-21-2020 17:10:38
(UTC-06:00) Central
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
Sep-21-2020 17:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-22-2020 05:13:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020365378Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817148
Page 177 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-26-2021 15:08:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-26-2021 14:38:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-26-2021 14:38:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/18/2021Transcription Error
Jan-26-2021 14:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Per source, subject
was contacted on
18Jan21. Please
review and update
as needed.
Jan-18-2021 11:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2021Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817149
Page 178 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-24-2021 13:29:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible and NOT confirmed
to have received only placeb
o at Vaccination 1/2New Information
Feb-08-2021 14:49:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Closed Response satisfies
query
Feb-08-2021 09:58:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed
Information
Feb-08-2021 09:58:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willing to re
turn for Vaccination 3 OR other
wise not eligibleChanged
Information
Feb-08-2021 07:02:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened CLINQUERY: Since
subject appears to
have changed their
mind in regard to
vaccination after
unblind, please
update status
selection to be
PARTICIPANT
NOT WILLING.
Subject's visits then
can continue as
normal
Feb-05-2021 14:30:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Reissued:Candidate CLINQUERY: Since
subject appears to
have changed their
mind in regard to
vaccination after
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0817150
Page 179 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
unblind, please
update status
selection to be
PARTICIPANT
NOT WILLING.
Subject's visits then
can continue as
normal
Feb-05-2021 11:23:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Subject withdrew
from additional
vaccinations and
will not be returning
for Vaccination 2.
Subject agrees to
continue with all
other remaining
visits and
procedures.
Feb-05-2021 10:34:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Opened CLINQUERY:
Subject reported to
be on active vaccine
in first phase. Will
subject be returning
to study to receive
vaccination 2?
Jan-18-2021 11:45:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-18-2021 11:45:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-18-2021 11:45:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0817151
Page 180 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eligible and NOT confirmed
to have received only placeb
o at Vaccination 1/2
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817152
Page 181 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date Treatment Unblinded :
Date Location User ValueReason
Feb-23-2021
16:39:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_36
Feb-23-2021
12:42:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7352783;Date
Treatment Unblinded
should be equal to or
after DOV in REVAX
CONTACT visit when
Reason is ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION.Please
review and update as
appropriate.
Feb-23-2021
07:55:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Jan/18
/2021Transcription Error
Jan-18-2021
11:45:21
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Jan/14
/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Feb-25-2021
00:04:29
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_35
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0817153
Page 182 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Canada)
Feb-24-2021
13:30:08
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dcompleted
Feb-23-2021
16:21:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Rivkah Rosen Query
1: Rei
ssued:
Opene
dDM: If subject did not
wish to return for
additional vaccination,
please consider
updating the Primary
Reason for Unblinding
in this form. Thank
you.
Feb-23-2021
07:57:29
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dsubject received 1st
vaccine, but was not
willing to return for
Vaccine #2 due to SAE.
Feb-22-2021
17:28:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7350630;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Jan-18-2021
11:45:21
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
ASSE
SS EL
IGIBI
LITY
FORInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0817154
Page 183 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
ADDI
TION
AL V
ACCI
NATI
ON
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817155
Page 184 of 185
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject Status
Date Location User Value Reason
Sep-25-2020 12:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Sep-04-2020 14:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-04-2020 14:24:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Sep-25-2020 12:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
Sep-04-2020 14:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
Sep-04-2020 14:24:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817156
Page 185 of 185
***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, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-27-2020 09:41:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Stephan
SharpData Entry:
Click Here to EnableInitial Entry
090177e196ae3fb3\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0817157