125742 S1 M5 CRF c4591001 1111 11111130

Document text

Page 1 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929842
Page 2 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/18/2020
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929843
Page 3 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11111130]
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): AMERICAN INDIAN OR ALASKA NATIVE
6.Racial Designation:
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929844
Page 4 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/18/2020
2.Erroneous Visit
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929845
Page 5 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929846
Page 6 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929847
Page 7 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Low libido]
Start Date: UNK/UNK/2012
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vitamin D deficiency]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Farsighted]
Start Date: UNK/UNK/2012
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Back Pain]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929848
Page 8 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/1987
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal allergies]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929849
Page 9 of 138
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Aug/18/2020
2.Weight: [146.8]
3.Unit: LB
4.Height: [63.5]
5.Unit: in
6.Body Mass Index: [25.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929850
Page 10 of 138
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/18/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929851
Page 11 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/18/2020
2.Randomization Number: [55002]
3.Randomization Group: [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929852
Page 12 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/18/2020
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 [BP5CFR]
5.bSample ID [BP5CFS]
5.cSample ID [BP5CFT]
5.dSample ID [BLD2TM]
5.eSample ID [BLD2TN]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929853
Page 13 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/18/2020
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 [BP5CFV]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929854
Page 14 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/18/2020 15:18
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
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929855
Page 15 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929856
Page 16 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929857
Page 17 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929858
Page 18 of 138
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/24/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929859
Page 19 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/24/2020
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 [BP9RC4]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929860
Page 20 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Sep/9/2020
Reason(s) for Temporary Delay of Vaccination
RECENT SYSTEMIC CORTICOSTEROID TREATMENT
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/24/2020 11:38
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
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929861
Page 21 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929862
Page 22 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
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 [BPY9P1]
5.bSample ID [BPY9P2]
5.cSample ID [BPY9P3]
5.dSample ID [BRTHD8]
5.eSample ID [BRTHD9]
5.fSample ID [BRTHDB]
5.gSample ID [BRTHDC]
5.hSample ID [BRTHDD]
5.iSample ID [BRTHDF]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929863
Page 23 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929864
Page 24 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929865
Page 25 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929866
Page 26 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929867
Page 27 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929868
Page 28 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929869
Page 29 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929870
Page 30 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929871
Page 31 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929872
Page 32 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929873
Page 33 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929874
Page 34 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929875
Page 35 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929876
Page 36 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929877
Page 37 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929878
Page 38 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929879
Page 39 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929880
Page 40 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929881
Page 41 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929882
Page 42 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929883
Page 43 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Subarachnoid hemo
rrhage Aug/26/2020 UNK
:UNK NO
End Date Time:
Sep/3/2020 UNK:UNK
 Repeating
Pages
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929884
Page 44 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[Subarachnoid hemorrhage]
4.Start Date Time: Aug/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/3/2020 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?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929885
Page 45 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
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[2020350026]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929886
Page 46 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929887
Page 47 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929888
Page 48 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929889
Page 49 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: //
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929890
Page 50 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defi
ned Identifie
rCategory for MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose De
scriptionForm Instan
ce
 1. DELETED 1  CONCOMITANT IMMUN
OSUPPRESSIVE THERAP
Y NO  Methylpre
dnisolone 4  Repeating
Pages
 2. DELETED 2  CORTICOSTEROIDS  NO  Dexametha
sone 8.0  Repeating
Pages
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929891
Page 51 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Methylprednisolone ]
5.Dose: [4]
6.Dose Unit: mg
7.Dose Frequency: ONCE
8.Route: ORAL
9.Start Date: Aug/24/2020
10.Ongoing? NO
End Date:
Aug/26/2020
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929892
Page 52 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Dexamethasone ]
5.Dose: [8.0]
6.Dose Unit: mg
7.Dose Frequency: ONCE
8.Route: INTRAVENOUS
9.Start Date: Aug/27/2020
10.Ongoing? NO
End Date:
Aug/27/2020
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929893
Page 53 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929894
Page 54 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929895
Page 55 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929896
Page 56 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929897
Page 57 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929898
Page 58 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929899
Page 59 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929900
Page 60 of 138
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929901
Page 61 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929902
Page 62 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929903
Page 63 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929904
Page 64 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929905
Page 65 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929906
Page 66 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929907
Page 67 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929908
Page 68 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929909
Page 69 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/12/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929910
Page 70 of 138
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929911
Page 71 of 138
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929912
Page 72 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/22/2020
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929913
Page 73 of 138
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929914
Page 74 of 138
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Stephens Approved Mar-01-2021 19:08:25 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelStephens, 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.
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929915
Page 75 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-19-2020 08:01:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929916
Page 76 of 138
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Stephens Approved Mar-01-2021 19:08:25 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelStephens, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-25-2021 16:49:49 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Stephens Approved Feb-25-2021 08:44:19 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelStephens, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-12-2021 14:44:12 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929917
Page 77 of 138
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Michael
Stephens Approved Nov-06-2020 10:30:14 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelStephens, 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 Oct-22-2020 15:53:15 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Stephens Approved Oct-22-2020 09:02:10 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelStephens, 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.
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929918
Page 78 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-19-2020 07:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-19-2020 07:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929919
Page 79 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-19-2020 07:59:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/18/2020Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929920
Page 80 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-19-2020 07:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11111130Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-19-2020 07:59:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1972Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-19-2020 08:00:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-19-2020 08:00:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-19-2020 08:00:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AMERICAN INDIAN OR AL
ASKA NATIVEInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929921
Page 81 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-19-2020 08:00:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/18/2020Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929922
Page 82 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-19-2020 08:01:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-19-2020 08:01:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-19-2020 08:01:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929923
Page 83 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Aug-19-2020 08:18:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:Low libido
Start Date: UNK/UNK/2
012
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-19-2020 08:18:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 08:18:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low libidoInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-19-2020 08:18:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-19-2020 08:18:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929924
Page 84 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-19-2020 08:18:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Vitamin D defic
iency
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-19-2020 08:18:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 08:18:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Vitamin D deficiencyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-19-2020 08:18:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-19-2020 08:18:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-19-2020 08:19:32 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929925
Page 85 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Number: 3
Medical History T
erm:Farsighted
Start Date: UNK/UNK/2
012
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-19-2020 08:19:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 08:19:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FarsightedInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-19-2020 08:19:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-19-2020 08:19:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-19-2020 08:19:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History T
erm:Back PainInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929926
Page 86 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Start Date: UNK/UNK/2
000
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-19-2020 08:19:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 08:19:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Back PainInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-19-2020 08:19:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-19-2020 08:19:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-19-2020 08:20:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History T
erm:Depression
Start Date: UNK/UNK/1
987
Ongoing: YESInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929927
Page 87 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.e Line/MH Number:
Date Location User Value Reason
Aug-19-2020 08:20:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 08:20:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DepressionInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-19-2020 08:20:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1987Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-19-2020 08:20:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-19-2020 08:20:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:Seasonal aller
gies
Start Date: UNK/UNK/2
017
Ongoing: YESInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929928
Page 88 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.f Line/MH Number:
Date Location User Value Reason
Aug-19-2020 08:20:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 08:20:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Seasonal allergiesInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-19-2020 08:20:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-19-2020 08:20:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929929
Page 89 of 138
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Aug-19-2020 08:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-19-2020 08:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
146.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-19-2020 08:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-19-2020 08:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
63.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-19-2020 08:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-19-2020 08:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25.6Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (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-2021-5683-0929930
Page 90 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.a
Date Location User Value Reason
Aug-19-2020 08:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.7
Temperature Unit: F
Temperature Loca
tion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-19-2020 08:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-19-2020 08:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-19-2020 08:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-19-2020 08:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (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-2021-5683-0929931
Page 91 of 138
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-19-2020 08:11:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-19-2020 08:11:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-19-2020 08:11:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-19-2020 08:11:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-19-2020 08:11:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-19-2020 08:11:52
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929932
Page 92 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-19-2020 08:11:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-19-2020 08:11:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Aug-19-2020 08:11:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929933
Page 93 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-19-2020 08:12:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-19-2020 08:12:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
55002Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929934
Page 94 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 08:02:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 08:02:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020 08:02:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-19-2020 08:02:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP5CFRInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929935
Page 95 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Aug-19-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP5CFRInitial Entry
5.b
Date Location User Value Reason
Aug-19-2020 08:03:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP5CFSInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-19-2020 08:03:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP5CFSInitial Entry
5.c
Date Location User Value Reason
Aug-19-2020 08:03:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP5CFTInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-19-2020 08:03:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP5CFTInitial Entry
5.d
Date Location User Value Reason
Aug-19-2020 08:03:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLD2TMInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (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-2021-5683-0929936
Page 96 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Aug-19-2020 08:03:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLD2TMInitial Entry
5.e
Date Location User Value Reason
Aug-19-2020 08:03:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLD2TNInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-19-2020 08:03:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLD2TNInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929937
Page 97 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 08:01:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 08:01:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020 08:01:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020 08:01:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-19-2020 08:01:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020 08:01:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP5CFVInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929938
Page 98 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Aug-19-2020 08:01:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP5CFVInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929939
Page 99 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-19-2020 08:12:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-19-2020 08:12:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-19-2020 08:12:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-19-2020 08:12:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/18/2020 15:18Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-19-2020 08:12:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-19-2020 08:12:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929940
Page 100 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7. Route:
Date Location User Value Reason
Aug-19-2020 08:12:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-19-2020 08:12:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-19-2020 08:12:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929941
Page 101 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-19-2020 08:12:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929942
Page 102 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-24-2020 13:59:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929943
Page 103 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020 14:02:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
2.a
Date Location User Value Reason
Sep-24-2020 14:02:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.6
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-24-2020 14:02:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-24-2020 14:02:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-24-2020 14:02:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (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-2021-5683-0929944
Page 104 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-24-2020 14:02:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929945
Page 105 of 138
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-24-2020 14:06:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-24-2020 14:06:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-24-2020 14:06:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-24-2020 14:06:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-24-2020 14:06:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-24-2020 14:06:56
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929946
Page 106 of 138
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-24-2020 14:06:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-24-2020 14:06:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-24-2020 14:06:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929947
Page 107 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 17:03:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 17:03:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020 17:03:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020 17:02:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9RC4Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020 17:02:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9RC4Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929948
Page 108 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-24-2020 14:11:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of First Delay:
Sep/9/2020
Reason(s) for Temporary Delay
of Vaccination
RECENT SYSTEMIC CORTI
COSTEROID TREATMENTInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020 14:11:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020 14:11:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-24-2020 14:11:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020 11:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020 14:11:03
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929949
Page 109 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
6. Body Side:
Date Location User Value Reason
Sep-24-2020 14:11:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-24-2020 14:11:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-24-2020 14:11:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-24-2020 14:11:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929950
Page 110 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-22-2020 15:53:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929951
Page 111 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 21:39:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 21:39:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 21:39:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 21:39:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-22-2020 21:39:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020 21:39:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY9P1Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929952
Page 112 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 21:39:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY9P1Initial Entry
5.b
Date Location User Value Reason
Oct-22-2020 21:39:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY9P2Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020 21:39:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY9P2Initial Entry
5.c
Date Location User Value Reason
Oct-22-2020 21:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY9P3Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020 21:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY9P3Initial Entry
5.d
Date Location User Value Reason
Oct-22-2020 21:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTHD8Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (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-2021-5683-0929953
Page 113 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Oct-22-2020 21:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTHD8Initial Entry
5.e
Date Location User Value Reason
Oct-22-2020 21:40:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTHD9Initial Entry
5.e Sample ID
Date Location User Value Reason
Oct-22-2020 21:40:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTHD9Initial Entry
5.f
Date Location User Value Reason
Oct-22-2020 21:40:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTHDBInitial Entry
5.f Sample ID
Date Location User Value Reason
Oct-22-2020 21:40:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTHDBInitial Entry
5.g
Date Location User Value Reason
Oct-22-2020 21:41:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTHDCInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (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-2021-5683-0929954
Page 114 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.g Sample ID
Date Location User Value Reason
Oct-22-2020 21:41:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTHDCInitial Entry
5.h
Date Location User Value Reason
Oct-22-2020 21:41:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTHDDInitial Entry
5.h Sample ID
Date Location User Value Reason
Oct-22-2020 21:41:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTHDDInitial Entry
5.i
Date Location User Value Reason
Oct-22-2020 21:41:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTHDFInitial Entry
5.i Sample ID
Date Location User Value Reason
Oct-22-2020 21:41:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTHDFInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (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-2021-5683-0929955
Page 115 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-22-2020 15:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-22-2020 15:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-22-2020 15:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929956
Page 116 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Sep-09-2020 16:29:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929957
Page 117 of 138
***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, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Sep-09-2020 16:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-09-2020 16:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-16-2020 13:41:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-15-2020 10:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered No family history
per subject
Sep-10-2020 18:13:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL please
review with subject
on any family
history of bleeding
or clotting events or
disorders, for
submission in a
followup SAE
report
Sep-09-2020 16:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Subarachnoid hemorrhageInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929958
Page 118 of 138
***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, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-09-2020 16:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-09-2020 16:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/3/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-09-2020 16:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-30-2020 20:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Oct-30-2020 09:42:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered will submit updated
SAE FU report
Oct-27-2020 21:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened Clinical – Thank
you. While awaiting
additional records,
please submit
Awaiting Med
Records to
determine if COVID
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (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-2021-5683-0929959
Page 119 of 138
***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, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
testing was
Performed as a SAE
safety followup.
Oct-27-2020 11:06:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Ok. Thanks
Oct-26-2020 22:37:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened Query closed; will
follow for SAE
update containing
requested COVID
test info, when med
records arrive
Oct-23-2020 11:36:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Awaiting medical
records so no
definitive
information
received. Will
submit follow-up
when information
received
Oct-22-2020 23:16:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical - COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020350026] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
Sep-10-2020 06:24:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-09-2020 16:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Subarachnoid
hemorrhage:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929960
Page 120 of 138
***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, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
blank.
Sep-09-2020 16:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
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-09-2020 16:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929961
Page 121 of 138
***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, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-09-2020 16:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-09-2020 16:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-09-2020 16:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-09-2020 16:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-09-2020 16:29:37
(UTC-05:00) Eastern
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-09-2020 16:29:37
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (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-2021-5683-0929962
Page 122 of 138
***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, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-10-2020 06:24:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020350026Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929963
Page 123 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Sep-30-2020 09:53:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Deleted Entered in error
per previous
query
Sep-24-2020 14:32:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929964
Page 124 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Oct-08-2020 15:26:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Oct-07-2020 13:47:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929965
Page 125 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Sep-24-2020 14:32:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Sep-24-2020 14:32:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CONCOMITANT IMMUNOSUP
PRESSIVE THERAPYInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Sep-24-2020 14:32:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter
the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use,
formulation).
Date Location User Value Reason
Oct-06-2020 22:25:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-30-2020 09:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Sep-29-2020 21:50:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:
Methylprednisolone:
Added to the con med
prohibited CRF but
does not qualify as
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929966
Page 126 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
prohibited per the
protocol i.e., =20
mg/day for =14 days.
Please review and
update as appropriate,
or otherwise clarify.
Sep-24-2020 14:32:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MethylprednisoloneInitial Entry
5. Dose:
Date Location User Value Reason
Sep-24-2020 14:32:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
6. Dose Unit:
Date Location User Value Reason
Sep-24-2020 14:32:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Sep-24-2020 14:32:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ONCEInitial Entry
8. Route:
Date Location User Value Reason
Sep-24-2020 14:32:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORALInitial Entry
9. Start Date:
Date Location User Value Reason
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (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-2021-5683-0929967
Page 127 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Sep-30-2020 17:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Sep-30-2020 09:52:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Entered in error
Sep-28-2020 17:47:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
clarify the purpose
of corticosteroids
use. If it was for
SAH which was
started on 8/26/20.
Please verify the
Start and End date
for this conmed.
Sep-24-2020 14:32:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
10. Ongoing?
Date Location User Value Reason
Sep-24-2020 14:32:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Aug/26/2020Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0929968
Page 128 of 138
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-07-2020 13:47:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
2. Category:
Date Location User Value Reason
Oct-07-2020 13:47:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CORTICOSTEROIDSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-07-2020 13:47:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter
the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use,
formulation).
Date Location User Value Reason
Oct-13-2020 08:18:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Luke
CunliffeQuery 1: Closed Response satisfies
query.
Oct-08-2020 15:25:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Oct-08-2020 15:08:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Luke
CunliffeQuery 1: Opened ClinQuery: This
does not qualify as
prohibited per the
protocol i.e., ≥20
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0929969
Page 129 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
mg/day for ≥14 days
(section 6.5.1).
Please review and
update appropriately.
Oct-07-2020 13:47:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DexamethasoneInitial Entry
5. Dose:
Date Location User Value Reason
Oct-07-2020 13:47:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
8.0Initial Entry
6. Dose Unit:
Date Location User Value Reason
Oct-07-2020 13:47:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Oct-07-2020 13:47:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ONCEInitial Entry
8. Route:
Date Location User Value Reason
Oct-07-2020 13:47:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
INTRAVENOUSInitial Entry
9. Start Date:
Date Location User Value Reason
Oct-07-2020 13:47:26 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0929970
Page 130 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-05:00) Eastern
Time (US & Canada)Aug/27/2020
10. Ongoing?
Date Location User Value Reason
Oct-07-2020 13:47:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Aug/27/2020Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929971
Page 131 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021 16:49:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021Transcription Error
Feb-12-2021 14:44:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/12/2021Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929972
Page 132 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-12-2021 14:44:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed to
have received only placebo at V
accination 1/2Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929973
Page 133 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date Treatment Unblinded :
Date Location User ValueReason
Feb-25-2021
23:35:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies
query
Feb-25-2021
16:50:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription Error
Feb-25-2021
16:50:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Feb/1
2/202
1Transcription Error
Feb-23-2021
02:18:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7351375;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-12-2021
14:44:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Jan/27
/2021Initial Entry
2. Primary Reason for Unblinding:
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0929974
Page 134 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Feb-12-2021 14:44:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929975
Page 135 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-22-2020 15:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-19-2020 08:12:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-19-2020 08:01:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-16-2020 12:02:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Dec-09-2020 09:38:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered An SAE update was
sent 09/16/2020 to
correct initial SAE
report. The update
reflected that a 2nd
angiogram
confirmed there was
no source of
bleeding. 1st angio =
SA bleed, 2nd angio
= no CV bleed
Dec-07-2020 14:12:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINICAL For
reviewers unfamiliar
with case, please
clarify angio
#/reason to repeat.
SAE “..angiogram
done on 27Aug2020
showed
subarachnoid
hemorrhage. On
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929976
Page 136 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
03Sep2020, an
angiogram showed
CV hemorrhage &
then, a 2nd
angiogram
confirmed no source
of bleed."
Dec-03-2020 14:20:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed thank you for
clarifying.
Dec-03-2020 14:15:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered The angiogram was
performed to see
whether there was
bleeding, not to
confirm she was still
bleeding. No update
is needed as the SAE
dated 09-Sep-2020
states "...after second
angiogram
confirmed no source
of bleed".
Dec-02-2020 16:36:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLINICAL - Thank
you. If correctly
understood, the
subject was (rather
than 'was not'?) still
bleeding on the day
of the second angio.
Please submit a SAE
safety update with
this clarifying
information..
Dec-02-2020 13:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered The second angio
was performed to
confirm bleeding
activity
Dec-02-2020 11:55:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL - please
clarify for SAE
Subarachnoid
hemorrhage if the
2nd angiogram was
performed due to
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (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-2021-5683-0929977
Page 137 of 138
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
continued bleeding
activity, to simply
look again for an
aneurysm, or for
other reason. Please
update SAE
(#2020350026) to
clarify
Oct-22-2020 15:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
Aug-19-2020 08:12:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
Aug-19-2020 08:01:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929978
Page 138 of 138
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111130 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-12-2020 11:01:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e47\Final\Final On: 01-Apr-2021 04:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929979