125742 S1 M5 CRF c4591001 1107 11071191

Document text

Page 1 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975271
Page 2 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/2/2020
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975272
Page 3 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [11071191]
2.Birth Date: 1950
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975273
Page 4 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975274
Page 5 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975275
Page 6 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975276
Page 7 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[OSTEOARTHRITIS]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[GASTROESOPHAGEAL REFLUX DISEASE]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975277
Page 8 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[2ND TOE- RIGHT FOOT HAMMER TOE]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
Jul/20/2020
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[RIGHT 2ND TOE HAMMER TOE REPAIR]
Start Date: Jul/20/2020
Ongoing: NO
End Date:
Jul/20/2020
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[TUBAL LIGATION]
Start Date: UNK/UNK/1983
Ongoing: NO
End Date:
UNK/UNK/1983
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975278
Page 9 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[POST MENOPAUSAL]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975279
Page 10 of 243
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [152.0]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [26.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975280
Page 11 of 243
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975281
Page 12 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [248364]
3.Randomization Group: [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975282
Page 13 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BPYKM1]
5.bSample ID [BPYKMH]
5.cSample ID [BPYKMJ]
5.dSample ID [BPL4SB]
5.eSample ID [BPL4SC]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975283
Page 14 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BPYKLL]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975284
Page 15 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/2/2020 09:45
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975285
Page 16 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975286
Page 17 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975287
Page 18 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Sep/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975288
Page 19 of 243
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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:
Not Done: NOT DONE
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975289
Page 20 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [BPYKTM]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975290
Page 21 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/24/2020 08:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975291
Page 22 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975292
Page 23 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/26/2020
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 [BPYDZT]
5.bSample ID [BNWX4R]
5.cSample ID [BNWX4D]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975293
Page 24 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975294
Page 25 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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: [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975295
Page 26 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975296
Page 27 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975297
Page 28 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975298
Page 29 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975299
Page 30 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975300
Page 31 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975301
Page 32 of 243
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975302
Page 33 of 243
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Unplanned Assessments
1.Assessments
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975303
Page 34 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/26/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975304
Page 35 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975305
Page 36 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975306
Page 37 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975307
Page 38 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse E
vent Still Ongoin
gForm Insta
nce
 1.ADVER
SE EVE
NT 1 OSTEOPENIA  Dec/UNK/20
20 UNK:UN
K YES  Repeating
Pages
 2.ADVER
SE EVE
NT 2 UTERINE PAPILLAR
Y SEROUS CARCIN
OMA Nov/UNK/2
020 UNK:U
NK NO
End Date Time:
Dec/30/2020 U
NK:UNK
 Repeating
Pages
 3.ADVER
SE EVE
NT 3 LEFT ABDOMINAL
PORT SITE INFECTI
ON Jan/12/2021
UNK:UNK NO
End Date Time:
Jan/14/2021 U
NK:UNK
 Repeating
Pages
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975308
Page 39 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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)[OSTEOPENIA]
4.Start Date Time: Dec/UNK/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975309
Page 40 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975310
Page 41 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975311
Page 42 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[UTERINE PAPILLARY SEROUS CARCINOMA]
4.Start Date Time: Nov/UNK/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/30/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975312
Page 43 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN CAUSE]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975313
Page 44 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[2021082250]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975314
Page 45 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[LEFT ABDOMINAL PORT SITE INFECTION]
4.Start Date Time: Jan/12/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/14/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975315
Page 46 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[POST SURGICAL INFECTION]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975316
Page 47 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975317
Page 48 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975318
Page 49 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975319
Page 50 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
 1.1  VACCINATI
ONS NO  INFLUENZ
A VACCINE Oct/9/
2020 Repeating
Pages
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975320
Page 51 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
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).[INFLUENZA VACCINE]
5.Date: Oct/9/2020
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975321
Page 52 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975322
Page 53 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975323
Page 54 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975324
Page 55 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975325
Page 56 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975326
Page 57 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975327
Page 58 of 243
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975328
Page 59 of 243
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975329
Page 60 of 243
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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:
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975330
Page 61 of 243
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975331
Page 62 of 243
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975332
Page 63 of 243
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975333
Page 64 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975334
Page 65 of 243
***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, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975335
Page 66 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975336
Page 67 of 243
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975337
Page 68 of 243
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975338
Page 69 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975339
Page 70 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/18/2021
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975340
Page 71 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975341
Page 72 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/18/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975342
Page 73 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975343
Page 74 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/18/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNWXBJ]
5.bSample ID [BNWXB6]
5.cSample ID [BRMWMG]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975344
Page 75 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/18/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYF45]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975345
Page 76 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/18/2021 11:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975346
Page 77 of 243
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975347
Page 78 of 243
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975348
Page 79 of 243
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMWS5]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975349
Page 80 of 243
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/8/2021 10:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975350
Page 81 of 243
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975351
Page 82 of 243
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975352
Page 83 of 243
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975353
Page 84 of 243
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975354
Page 85 of 243
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975355
Page 86 of 243
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975356
Page 87 of 243
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975357
Page 88 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/26/2020
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975358
Page 89 of 243
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975359
Page 90 of 243
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Harry
Studdard Approved Mar-12-2021 12:15:33 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HarryStuddard, 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.
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975360
Page 91 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormSep-02-2020 14:41:09 (UTC-06:00)
Central Time (US & Canada)SUBJECT MET ALL INC/EXC
CRITERIA
Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975361
Page 92 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormSep-02-2020 14:52:58 (UTC-06:00)
Central Time (US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975362
Page 93 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Sep-02-2020 14:52:58 (UTC-06:00)
Central Time (US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975363
Page 94 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Sep-02-2020 14:52:58 (UTC-06:00)
Central Time (US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975364
Page 95 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Sep-02-2020 14:52:58 (UTC-06:00)
Central Time (US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975365
Page 96 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Sep-02-2020 14:52:58 (UTC-06:00)
Central Time (US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975366
Page 97 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Sep-02-2020 14:52:58 (UTC-06:00)
Central Time (US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975367
Page 98 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aSep-02-2020 14:52:58 (UTC-06:00)
Central Time (US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975368
Page 99 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aSep-02-2020 14:52:58 (UTC-06:00)
Central Time (US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975369
Page 100 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aSep-02-2020 14:52:58 (UTC-06:00)
Central Time (US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975370
Page 101 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormJan-19-2021 08:25:50 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975371
Page 102 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormJan-19-2021 08:26:34 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
 
 
 
(b) (4)
FDA-CBER-2021-5683-0975372
Page 103 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Jan-19-2021 08:26:34 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975373
Page 104 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Jan-19-2021 08:26:34 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975374
Page 105 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Jan-19-2021 08:26:34 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975375
Page 106 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Jan-19-2021 08:26:34 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975376
Page 107 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Jan-19-2021 08:26:34 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975377
Page 108 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aJan-19-2021 08:26:34 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975378
Page 109 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aJan-19-2021 08:26:34 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975379
Page 110 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aJan-19-2021 08:26:34 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975380
Page 111 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-09-2021 13:15:30 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975381
Page 112 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Feb-09-2021 13:15:30 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975382
Page 113 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Feb-09-2021 13:15:30 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975383
Page 114 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Feb-09-2021 13:15:30 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975384
Page 115 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Feb-09-2021 13:15:30 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975385
Page 116 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Feb-09-2021 13:15:30 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975386
Page 117 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aFeb-09-2021 13:15:30 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975387
Page 118 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aFeb-09-2021 13:15:30 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975388
Page 119 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aFeb-09-2021 13:15:30 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975389
Page 120 of 243
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Harry
Studdard Approved Mar-12-2021 12:15:33 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HarryStuddard, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-27-2021 13:24:29 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Harry
Studdard Approved Jan-20-2021 19:07:30 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0975390
Page 121 of 243
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Affidavit:
By my dated signature below, I, HarryStuddard, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-19-2021 08:22:36 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Harry
Studdard Approved Nov-02-2020 15:07:09 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HarryStuddard, 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.
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0975391
Page 122 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-02-2020
14:40:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-02-2020
14:40:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975392
Page 123 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-02-2020
14:40:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Sep/2/2020Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975393
Page 124 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-02-2020
14:39:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11071191Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-02-2020
14:39:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1950Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-02-2020
14:40:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975394
Page 125 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-02-2020
14:40:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-02-2020
14:40:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975395
Page 126 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020
14:40:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975396
Page 127 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-02-2020
14:41:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-02-2020
14:41:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-02-2020
14:41:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975397
Page 128 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.a
Date Location User Value Reason
Sep-02-2020
14:42:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:OSTEOA
RTHRITI
S
Start Date: UNK/UN
K/2017
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-02-2020
14:42:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:42:41
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
OSTEOARTHRITI
SInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975398
Page 129 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada)
1.a Start Date:
Date Location User Value Reason
Sep-02-2020
14:42:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-02-2020
14:42:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-02-2020
14:43:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:2
Medical
History
Term:HYPERCH
OLESTER
OLEMIA
Start Da
te:UNK/UNK/
2015Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975399
Page 130 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Ongoing
:YES
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975400
Page 131 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.b Line/MH Number:
Date Location User Value Reason
Sep-02-2020
14:43:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:43:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HYPERCHOLEST
EROLEMIAInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-02-2020
14:43:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-02-2020
14:43:06ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975401
Page 132 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)
1.c
Date Location User Value Reason
Sep-02-2020
14:43:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:3
Medica
l Histor
y Term
:GASTROES
OPHAGEAL
REFLUX DI
SEASE
Start D
ate:UNK/UNK/2
018
Ongoin
g:YESInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975402
Page 133 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.c Line/MH Number:
Date Location User Value Reason
Sep-02-2020
14:43:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:43:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
GASTROESOPHA
GEAL REFLUX DI
SEASEInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-02-2020
14:43:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-02-2020
14:43:38ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975403
Page 134 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)
1.d
Date Location User Value Reason
Sep-02-2020
14:44:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:4
Medica
l Histo
ry Ter
m:2ND TOE- RI
GHT FOOT
HAMMER T
OE
Start D
ate:UNK/UNK/2
018
Ongoin
g:NO
End Date:
Jul/20/202
0Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975404
Page 135 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.d Line/MH Number:
Date Location User Value Reason
Sep-02-2020
14:44:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:44:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2ND TOE- RIGHT
FOOT HAMMER T
OEInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-02-2020
14:44:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-02-2020
14:44:20ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975405
Page 136 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)End Date:
Jul/20/2020
1.e
Date Location User Value Reason
Sep-02-2020
14:45:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:5
Medica
l Histo
ry Ter
m:RIGHT 2ND
TOE HAMM
ER TOE REP
AIR
Start D
ate:Jul/20/2020
Ongoin
g:NO
End Date:
Jul/20/202
0Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975406
Page 137 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.e Line/MH Number:
Date Location User Value Reason
Sep-02-2020
14:45:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:45:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHT 2ND TOE
HAMMER TOE RE
PAIRInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-02-2020
14:45:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jul/20/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-02-2020
14:45:46ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975407
Page 138 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)End Date:
Jul/20/2020
1.f
Date Location User Value Reason
Sep-02-2020
14:51:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical H
istory Ter
m:TUBAL LI
GATION
Start Date
:UNK/UN
K/1983
Ongoing: NO
End Date
:
UNK/U
NK/198
3Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975408
Page 139 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.f Line/MH Number:
Date Location User Value Reason
Sep-02-2020
14:51:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:51:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
TUBAL LIGATIONInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-02-2020
14:51:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1983Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-02-2020
14:51:37ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975409
Page 140 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/1983
1.g
Date Location User Value Reason
Sep-02-2020
14:52:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical H
istory Ter
m:POST ME
NOPAUS
AL
Start Date
:UNK/UN
K/2000
Ongoing: YESInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975410
Page 141 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.g Line/MH Number:
Date Location User Value Reason
Sep-02-2020
14:52:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:52:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
POST MENOPAUS
ALInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-02-2020
14:52:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-02-2020
14:52:00ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975411
Page 142 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975412
Page 143 of 243
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020
14:52:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-02-2020
14:52:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
152.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-02-2020
14:52:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975413
Page 144 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-02-2020
14:52:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-02-2020
14:52:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-02-2020
14:52:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26.1Initial Entry
7.a
Date Location User Value Reason
Sep-02-2020
14:52:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperat
ure:98.3Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975414
Page 145 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Temperat
ure Unit:F
Temperat
ure Locati
on::ORAL
CAVIT
Y
Sep-02-2020
14:52:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature:
Temperature Un
it:
Temperature Lo
cation::Initial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-02-2020
14:52:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-02-2020
14:52:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975415
Page 146 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7.a Unit:
Date Location User Value Reason
Sep-02-2020
14:52:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-02-2020
14:52:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975416
Page 147 of 243
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-02-2020
14:52:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-02-2020
14:52:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-02-2020
14:52:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975417
Page 148 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-02-2020
14:52:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-02-2020
14:52:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-02-2020
14:52:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-D
efined Iden
tifier:Not A
pplica
ble
Test:: Not A
pplica
ble
Result:: Not A
pplica
ble
Not Done:: Not A
pplica
bleInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975418
Page 149 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
6.a Sponsor ID:
Date Location User Value Reason
Sep-02-2020
14:52:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-02-2020
14:52:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-02-2020
14:52:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-02-2020
14:52:58ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975419
Page 150 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975420
Page 151 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-02-2020
14:53:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-02-2020
14:53:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
248364Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975421
Page 152 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020
15:19:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020
15:19:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020
15:20:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-03-2020
15:19:52
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975422
Page 153 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-03-2020
15:19:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020
15:20:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPYK
M1Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020
15:20:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYKM1Initial Entry
5.b
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975423
Page 154 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Sep-03-2020
15:20:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPYKM
HInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-03-2020
15:20:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYKMHInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020
15:20:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPYK
MJInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975424
Page 155 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.c Sample ID
Date Location User Value Reason
Sep-03-2020
15:20:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYKMJInitial Entry
5.d
Date Location User Value Reason
Sep-03-2020
15:20:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPL4S
BInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-03-2020
15:20:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPL4SBInitial Entry
5.e
Date Location User Value Reason
Sep-03-2020
15:20:57ACV0PFEINFP6000  Data Entry:
Sample I BPL4SInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975425
Page 156 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)D: C
5.e Sample ID
Date Location User Value Reason
Sep-03-2020
15:20:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPL4SCInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975426
Page 157 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020
15:19:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020
15:19:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020
15:19:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-03-2020
15:19:31
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975427
Page 158 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-03-2020
15:19:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020
15:19:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPYKL
LInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020
15:19:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYKLLInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975428
Page 159 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-02-2020
14:58:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020
14:58:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020
14:58:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975429
Page 160 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-02-2020
14:58:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020 09:45Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020
14:58:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-02-2020
14:58:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-02-2020
14:58:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975430
Page 161 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-02-2020
14:58:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-02-2020
14:58:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975431
Page 162 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-02-2020
14:58:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTED
FOR THIS SUBJE
CTInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975432
Page 163 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-25-2020
13:05:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975433
Page 164 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020
13:06:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
2.a
Date Location User Value Reason
Sep-25-2020
13:06:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.3
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-25-2020
13:06:14
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975434
Page 165 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-25-2020
13:06:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-25-2020
13:06:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-25-2020
13:06:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975435
Page 166 of 243
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-25-2020
13:06:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-25-2020
13:06:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-25-2020
13:06:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975436
Page 167 of 243
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-25-2020
13:06:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-25-2020
13:06:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-25-2020
13:06:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result::
Not Done
::NOT DON
EInitial Entry
6.a Sponsor ID:
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975437
Page 168 of 243
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Sep-25-2020
13:06:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-25-2020
13:06:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-25-2020
13:06:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975438
Page 169 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020
13:07:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020
13:07:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020
13:07:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-25-2020
13:07:02
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975439
Page 170 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-25-2020
13:07:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020
13:07:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPYKT
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-25-2020
13:07:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYKTMInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975440
Page 171 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-25-2020
13:10:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020
13:10:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020
13:10:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975441
Page 172 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-25-2020
13:10:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020 08:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020
13:10:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-25-2020
13:10:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-25-2020
13:10:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975442
Page 173 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-25-2020
13:10:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-25-2020
13:10:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975443
Page 174 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-31-2020
23:34:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Data updated.
Oct-30-2020
09:19:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answere
dUPDATED
Oct-30-2020
03:33:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
treatment
period is
defined as 1st
vaccination
visit through
the 1-month
post
vaccination
visit after the
2nd
vaccination.
Please
complete
treatment
disposition
CRF and
update date of
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975444
Page 175 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
EOT to match
date of blood
sample
collection date
at visit 3.
Oct-26-2020
13:07:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975445
Page 176 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020
08:35:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020
08:35:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-27-2020
08:35:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-27-2020
08:35:19
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975446
Page 177 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-27-2020
08:35:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/26/2020Initial Entry
5.a
Date Location User Value Reason
Oct-27-2020
08:35:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPYDZ
TInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-27-2020
08:35:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYDZTInitial Entry
5.b
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975447
Page 178 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Oct-27-2020
08:35:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BNWX4
RInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-27-2020
08:35:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWX4RInitial Entry
5.c
Date Location User Value Reason
Oct-27-2020
08:35:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BNWX4
DInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975448
Page 179 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.c Sample ID
Date Location User Value Reason
Oct-27-2020
08:35:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWX4DInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975449
Page 180 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-30-2020
09:18:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-30-2020
09:18:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-30-2020
09:18:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975450
Page 181 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Jan-19-2021
09:35:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975451
Page 182 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Jan-19-2021
09:37:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975452
Page 183 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Jan-27-2021
13:29:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975453
Page 184 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Jan-19-2021
09:35:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-19-2021
09:35:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-27-2021
13:24:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OSTEOPENIANew
Information
Jan-19-2021
09:35:44
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
OSTEOPOROSISInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975454
Page 185 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time (US
& Canada)
4. Start Date Time:
Date Location User Value Reason
Jan-19-2021
09:35:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/UNK/2020 UN
K:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-19-2021
09:35:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-19-2021
09:35:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975455
Page 186 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
Jan-19-2021
09:35:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-19-2021
09:35:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-19-2021
09:35:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), t
his event is due to:Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975456
Page 187 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
OTHER
If Other, specify
:
UNKNOWN
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-19-2021
09:35:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-19-2021
09:35:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-19-2021
09:35:44
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975457
Page 188 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-19-2021
09:35:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-19-2021
09:35:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975458
Page 189 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Jan-19-2021
09:37:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-19-2021
09:37:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-27-2021
13:25:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UTERINE PAPIL
LARY SEROUS C
ARCINOMANew
Information
Jan-19-2021
09:37:31ACV0PFEINFP6000  Data Entry:
UTERINE CANCInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975459
Page 190 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)ER
4. Start Date Time:
Date Location User Value Reason
Feb-02-2021
20:20:34
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Clo
sedResponse satisfies
query
Feb-01-2021
10:31:14
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Ans
weredUN/NOV/2020 is the
date of first presenting
symptom
Jan-30-2021
20:37:09
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Rei
ssued:Opene
dClinical Thank you.
Please enter date of
first presenting
symptom of the SAE
as the start date.
Jan-29-2021
12:30:49
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Ans
weredSUBJECT HAD
POSTMENOPAUSAL
BLEEDING PRIOR
TO THE
THICKENED
ENDOMETRIUM
WHICH IS A
SYMPTOM OF
UTERINE CANCER
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (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-2021-5683-0975460
Page 191 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Jan-29-2021
11:02:39
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Ope
nedClinical Event start
date is ??Nov20;
however, SAE report
(#2021082250) states
that thickened
endometrium by
ultrasound was
detected on 24Nov20.
Please clarify if
subject had symptoms
of serous CA prior to
this; otherwise
consider full start date
(AE/SAE)
Jan-27-2021
19:30:43
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Samuel
DychterQuery 1: Clo
sedResponse satisfies
query
Jan-27-2021
13:26:11
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/UNK/20
20 UNK:UN
KNew Information
Jan-25-2021
15:35:42
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Ans
weredWhy would the start
date not be the date of
symptom onset?
Jan-20-2021
18:50:25ACV0PFEINFP6000  Samuel
DychterQuery 1: Ope
nedGPD Clin: Please
re-confirm the start
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0975461
Page 192 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time
(US & Canada)date. This would be
the date of
histopathological
diagnosis.
Jan-19-2021
09:37:31
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/UNK/20
20 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-30-2021
20:35:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Jan-29-2021
12:34:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answere
dEXISTING
SAE REPORT
LISTS
30DEC2020
AS THE
DATE OF
RECOVERY
Jan-29-2021
11:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened Clinical Event
end date is
30Dec20;
however SAE
report has no
end date.
Please submit a
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0975462
Page 193 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
SAE safety
update
reporting the
end date
Jan-19-2021
09:37:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/30/2020 U
NK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-27-2021
13:26:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
3New
Information
Jan-19-2021
09:37:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975463
Page 194 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
prevent above outcomes).
Date Location User Value Reason
Feb-01-2021
09:41:29
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Jan-27-2021
14:28:35
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Samuel
DychterQuery 1: Closed Response
satisfies query
Jan-27-2021
13:27:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candida
teFor AE
UTERINE
PAPILLARY
SEROUS
CARCINOMA:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Jan-27-2021
13:27:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious e
vent associated
with congenital
anomaly or birtNew
Information
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0975464
Page 195 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
h defect?
NO
Did this serious
event result in d
eath?
NO
Did this serious
event require or
prolong hospital
ization?
NO
Did this serious
event result in p
ersistent or sign
ificant disability
/incapacity?
NO
Is this serious e
vent life threate
ning?
NO
Other medically
important seriou
s event
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975465
Page 196 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
YES
Jan-26-2021
14:33:00
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edSpoke with PI,
he is agreeable
to making this
an SAE and we
will submit it
within the next
24 hours.
Jan-20-2021
18:56:33
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Samuel
DychterQuery 1: Opened GPD Clin:
Please consider
reporting this
event as an
SAE.
Jan-19-2021
09:37:31
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-19-2021
09:37:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0975466
Page 197 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Jan-27-2021
14:10:35
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Samuel
DychterQuery 1: Close
dResponse satisfies
query
Jan-25-2021
15:53:21
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answ
eredSubject confirms no
history of HPV or
abnormal/dysplastic
finding on Pap
smears
Jan-20-2021
18:52:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Samuel
DychterQuery 1: Opene
dGPD Clin: Please
confirm if the
subject has a
history HPV or if
she had
abnormal/dysplastic
findings on Pap
smears in the past.
If so, please add to
medical history.
Jan-19-2021
09:37:31
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATE
D
If Not Related
to study treat
ment(s), this e
vent is due to:
OTHERInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0975467
Page 198 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
If Other, sp
ecify:
UNKNO
WN CA
USE
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-19-2021
09:37:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-27-2021
13:27:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESNew
Information
Jan-19-2021
09:37:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975468
Page 199 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Jan-19-2021
09:37:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-19-2021
09:37:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-19-2021
09:37:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-01-2021
09:41:29
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
2021082250Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975469
Page 200 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada)
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975470
Page 201 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Jan-27-2021
13:29:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-27-2021
13:29:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-27-2021
13:29:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFT ABDOMINAL
PORT SITE INFECT
IONInitial Entry
4. Start Date Time:
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975471
Page 202 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Jan-27-2021
13:29:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/12/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-27-2021
13:29:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/14/2021 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-27-2021
13:29:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975472
Page 203 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Jan-27-2021
13:29:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-27-2021
13:29:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-27-2021
13:29:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975473
Page 204 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
POST SURGIC
AL INFECTIO
N
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-27-2021
13:29:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-27-2021
13:29:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-27-2021
13:29:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975474
Page 205 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Jan-27-2021
13:29:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-27-2021
13:29:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975475
Page 206 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Oct-26-2020
13:09:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975476
Page 207 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-26-2020
13:09:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Oct-26-2020
13:09:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-26-2020
13:09:06
(UTC-06:00)
Central 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
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975477
Page 208 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Oct-26-2020
13:09:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
INFLUENZA VAC
CINEInitial Entry
5. Date:
Date Location User Value Reason
Oct-26-2020
13:09:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975478
Page 209 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021
08:22:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975479
Page 210 of 243
***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, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-19-2021
08:24:03
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-19-2021
08:23:39
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-19-2021
08:23:39
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible per oth
er protocol allo
wance(s) and c
onfirmed to haInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975480
Page 211 of 243
***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, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
ve received onl
y placebo at Va
ccination 1/2
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975481
Page 212 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-19-2021
08:24:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-19-2021
08:24:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBIL
ITY FOR ADDITI
ONAL VACCINAT
IONInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975482
Page 213 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021
08:25:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975483
Page 214 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-19-2021
08:25:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Jan/18/2021Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975484
Page 215 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-19-2021
08:26:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-19-2021
08:26:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Jan-19-2021
08:26:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975485
Page 216 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-19-2021
08:26:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-19-2021
08:26:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-19-2021
08:26:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975486
Page 217 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Jan-19-2021
08:26:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-19-2021
08:26:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Jan-19-2021
08:26:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-D
efined Iden
tifier:Not A
pplica
ble
Test:: Not A
pplica
ble
Result:: Not A
pplica
ble
Not Done:: Not A
pplica
bleInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975487
Page 218 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
6.a Sponsor ID:
Date Location User Value Reason
Jan-19-2021
08:26:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Jan-19-2021
08:26:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Jan-19-2021
08:26:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Jan-19-2021
08:26:34ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975488
Page 219 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975489
Page 220 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021
12:37:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021
12:37:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021
12:37:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-19-2021
12:37:31
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975490
Page 221 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-19-2021
12:37:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Jan/18/2021Initial Entry
5.a
Date Location User Value Reason
Jan-19-2021
12:37:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BNWX
BJInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-19-2021
12:37:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWXBJInitial Entry
5.b
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975491
Page 222 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Jan-19-2021
12:38:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BNWX
B6Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-19-2021
12:38:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWXB6Initial Entry
5.c
Date Location User Value Reason
Jan-19-2021
12:38:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRMW
MGInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975492
Page 223 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.c Sample ID
Date Location User Value Reason
Jan-19-2021
12:38:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRMWMGInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975493
Page 224 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021
12:38:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021
12:38:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021
12:39:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-19-2021
12:38:46
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975494
Page 225 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-19-2021
12:38:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Jan/18/2021Initial Entry
5.a
Date Location User Value Reason
Jan-19-2021
12:39:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPYF4
5Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-19-2021
12:39:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYF45Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975495
Page 226 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-19-2021
08:27:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-19-2021
08:27:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-19-2021
08:27:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975496
Page 227 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Jan-19-2021
08:27:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/18/2021 11:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-19-2021
08:27:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-19-2021
08:27:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-19-2021
08:27:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975497
Page 228 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
8. Actual Dose:
Date Location User Value Reason
Jan-19-2021
08:27:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-19-2021
08:27:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-19-2021
08:27:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Jan-19-2021
08:27:11ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975498
Page 229 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975499
Page 230 of 243
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-09-2021
13:15:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/8/2021Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975500
Page 231 of 243
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-09-2021
13:15:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-09-2021
13:15:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-09-2021
13:15:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975501
Page 232 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Feb-09-2021
13:15:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-09-2021
13:15:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Feb-09-2021
13:15:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-D
efined Iden
tifier:Not A
pplica
ble
Test:: Not A
pplica
ble
Result:: Not A
pplica
ble
Not Done:: Not A
pplica
bleInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975502
Page 233 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
6.a Sponsor ID:
Date Location User Value Reason
Feb-09-2021
13:15:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Feb-09-2021
13:15:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Feb-09-2021
13:15:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Feb-09-2021
13:15:30ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975503
Page 234 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975504
Page 235 of 243
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-09-2021
15:24:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-09-2021
15:24:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-09-2021
15:24:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-09-2021
15:24:03
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975505
Page 236 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-09-2021
15:24:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Feb/8/2021Initial Entry
5.a
Date Location User Value Reason
Feb-09-2021
15:24:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRMW
S5Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-09-2021
15:24:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRMWS5Initial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975506
Page 237 of 243
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-09-2021
13:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-09-2021
13:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-09-2021
13:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975507
Page 238 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Feb-09-2021
13:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/8/2021 10:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-09-2021
13:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-09-2021
13:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-09-2021
13:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975508
Page 239 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
8. Actual Dose:
Date Location User Value Reason
Feb-09-2021
13:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-09-2021
13:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-09-2021
13:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-09-2021
13:16:11ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975509
Page 240 of 243
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3e03\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975510
Page 241 of 243
***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: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-30-2020
09:18:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-02-2020
14:53:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-02-2020
14:41:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-30-2020
09:18:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/26/2020Initial Entry
Sep-02-2020
14:53:39ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/2/2020Initial Entry
090177e1
…[truncated]