Document text
Page 1 of 206
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974923
Page 2 of 206
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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
Aug/6/2020
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974924
Page 3 of 206
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [11071065]
2.Birth Date: /1976
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0974925
Page 4 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/6/2020
2.Erroneous Visit
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974926
Page 5 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974927
Page 6 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/6/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974928
Page 7 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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:[TRAUMATIC RIGHT ANKLE FRACTURE]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RIGHT ANKLE REPAIR]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OVERWEIGHT]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974929
Page 8 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Aug/6/2020
2.Weight: [294.4]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [46.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974930
Page 9 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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: Aug/6/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974931
Page 10 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/6/2020
2.Randomization Number: [43573]
3.Randomization Group: [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974932
Page 11 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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:
Aug/6/2020
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 [BPLFJ6]
5.bSample ID [BPLFJ7]
5.cSample ID [BP3SGW]
5.dSample ID [BP3SGX]
5.eSample ID [BP3SGY]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974933
Page 12 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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:
Aug/6/2020
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 [BP3SFY]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974934
Page 13 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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: Aug/6/2020 15:01
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
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974935
Page 14 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS
SUBJECT
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974936
Page 15 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974937
Page 16 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974938
Page 17 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974939
Page 18 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974940
Page 19 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974941
Page 20 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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: Aug/27/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974942
Page 21 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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:
Aug/27/2020
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 [BPYKJ1]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974943
Page 22 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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: Aug/27/2020 07:48
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
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974944
Page 23 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974945
Page 24 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974946
Page 25 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974947
Page 26 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974948
Page 27 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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/29/2020
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 [BPYDVR]
5.bSample ID [BPL4ZW]
5.cSample ID [BPL506]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974949
Page 28 of 206
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974950
Page 29 of 206
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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 [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974951
Page 30 of 206
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974952
Page 31 of 206
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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 [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974953
Page 32 of 206
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974954
Page 33 of 206
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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 [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974955
Page 34 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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:
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974956
Page 35 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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: [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974957
Page 36 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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 [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974958
Page 37 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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 [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974959
Page 38 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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?
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974960
Page 39 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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:
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974961
Page 40 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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:
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974962
Page 41 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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 [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974963
Page 42 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit
on Aug/10/2020Form: 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: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/10/2020
2.Erroneous Visit
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974964
Page 43 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit
on Aug/10/2020Form: UNPLANNED VISIT
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: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974965
Page 44 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit
on Aug/10/2020Form: CONTACT OUTCOME - UNPLANNED
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: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/10/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [SUBJECT STATES SHE TOOK HER TEMPERATURE
08AUG2020 WHEN SHE WAS OUTSIDE IN THE HEAT
(103.3F). WHEN SHE REPEATED IT INSIDE AN HOUR
LATER AFTER NOT TAKING ANY MEDICATION IT WAS
98.3F.]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974966
Page 45 of 206
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Sep/29/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974967
Page 46 of 206
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death :Nov/18/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: PHYSICIAN DECISION
4.Specify Status: [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974968
Page 47 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB -
New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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:
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974969
Page 48 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB -
New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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 [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974970
Page 49 of 206
***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: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categor
yAE Id
entifie
rAdverse Event Start DateIs the Adverse
Event Still Ong
oingForm Insta
nce
1.ADVER
SE EVE
NT 1 MICROCYTIC ANEMIA Nov/9/202
0 UNK:U
NK YES Repeating
Pages
2.ADVER
SE EVE
NT 2 ABNORMAL RBC MORPH
OLOGY INCLUDING SICK
LE CELLS Nov/9/202
0 UNK:U
NK YES Repeating
Pages
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974971
Page 50 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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)[MICROCYTIC ANEMIA]
4.Start Date Time: Nov/9/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974972
Page 51 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
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
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974973
Page 52 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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?: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[2020450795]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974974
Page 53 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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)[ABNORMAL RBC MORPHOLOGY INCLUDING SICKLE
CELLS]
4.Start Date Time: Nov/9/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974975
Page 54 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
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
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974976
Page 55 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020450795]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974977
Page 56 of 206
***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: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication E
rrors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974978
Page 57 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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[ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974979
Page 58 of 206
***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: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicat
ions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974980
Page 59 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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.Date: //
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974981
Page 60 of 206
***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: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974982
Page 61 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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?
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974983
Page 62 of 206
***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: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Catego
ryTreatment Ide
ntifierCon Non-Drug Treatments Pr
e-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974984
Page 63 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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?
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974985
Page 64 of 206
***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: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
1.PACKED RBC Nov/10/2020 Repeating Pages
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974986
Page 65 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
1.Transfusion Type: PACKED RBC
2.Date of Transfusion: Nov/10/2020
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974987
Page 66 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974988
Page 67 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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:
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974989
Page 68 of 206
***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: 11071065 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:
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974990
Page 69 of 206
***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: 11071065 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?
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974991
Page 70 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974992
Page 71 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974993
Page 72 of 206
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974994
Page 73 of 206
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974995
Page 74 of 206
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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 [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974996
Page 75 of 206
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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 [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974997
Page 76 of 206
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
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: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974998
Page 77 of 206
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Further Vaccination Confirmation
1.Select appropriate response -
Is participant willing to
return for Vaccination 3?
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974999
Page 78 of 206
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for
Unblinding:
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975000
Page 79 of 206
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent Date
://
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975001
Page 80 of 206
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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: [ ]
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975002
Page 81 of 206
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/18/2020
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975003
Page 82 of 206
***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: 11071065 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
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975004
Page 83 of 206
***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: 11071065 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 Jan-20-2021 16:26:55 (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.
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975005
Page 84 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormAug-07-2020 08:33:43 (UTC-06:00)
Central Time (US & Canada)SUBJECT MET ALL INC/EXC
CRITERIA
Not Applicable
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975006
Page 85 of 206
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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 Jan-20-2021 16:26:55 (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 Dec-01-2020 14:12:34 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Harry
Studdard Approved Nov-17-2020 07:15:30 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0975007
Page 86 of 206
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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 Nov-16-2020 07:57:51 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Harry
Studdard Approved Oct-07-2020 15:10:34 (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 Sep-30-2020 07:15:24 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0975008
Page 87 of 206
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Affidavit:
N/A
Harry
Studdard Approved Sep-09-2020 15:58:41 (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.
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975009
Page 88 of 206
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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
Aug-07-2020
08:31:54
(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
Aug-07-2020
08:31:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975010
Page 89 of 206
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-07-2020
08:32:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/6/2020Initial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975011
Page 90 of 206
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-14-2020
01:43:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Closed by DM:
PM.
Aug-13-2020
09:19:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answere
dUNPLANNED
CONTACT
ADDED
Aug-12-2020
07:14:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened PDQ: Subject has
reported Severe
symptoms/reaction
in eDiary data on
08Aug2020.
Please confirm if
an UNPLANNED
contact was made
and update the
data as appropriate
Aug-07-2020
08:31:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11071065Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
090177e196ae3e00\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-2021-5683-0975012
Page 91 of 206
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-07-2020
08:31:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1976Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-07-2020
08:33:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-07-2020
08:33:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-07-2020
08:33:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRIC
AN AMERICANInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975013
Page 92 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-07-2020
08:33:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/6/2020Initial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975014
Page 93 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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
Aug-07-2020
08:34:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-07-2020
08:34:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-07-2020
08:34:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975015
Page 94 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.a
Date Location User Value Reason
Aug-07-2020
08:34:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:1
Medica
l Histor
y Term
:TRAUMATIC
RIGHT ANKL
E FRACTURE
Start D
ate:UNK/UNK/20
17
Ongoin
g:NO
End Date:
UNK/UNK/
2017Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-07-2020
08:34:42
(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
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975016
Page 95 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-07-2020
08:34:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
TRAUMATIC RIGH
T ANKLE FRACTU
REInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-07-2020
08:34:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-07-2020
08:34:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.b
Date Location User Value Reason
Aug-07-2020
08:35:17
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History T
erm:RIGHT AN
KLE REPAI
RInitial Entry
090177e196ae3e00\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-2021-5683-0975017
Page 96 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Start Date
:UNK/UNK/
2017
Ongoing: NO
End Date:
UNK/UN
K/2017
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975018
Page 97 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.b Line/MH Number:
Date Location User Value Reason
Aug-07-2020
08:35:17
(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
Aug-07-2020
08:35:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RIGHT ANKLE REP
AIRInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-07-2020
08:35:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-07-2020
08:35:17
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
NO
End Date:Initial Entry
090177e196ae3e00\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-2021-5683-0975019
Page 98 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time (US
& Canada) UNK/UNK/2017
1.c
Date Location User Value Reason
Aug-07-2020
08:35:51
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:OVERW
EIGHT
Start Date: UNK/UN
K/2010
Ongoing: YESInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975020
Page 99 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.c Line/MH Number:
Date Location User Value Reason
Aug-07-2020
08:35:51
(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
Aug-07-2020
08:35:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OVERWEIGHTInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-07-2020
08:35:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-07-2020
08:35:51
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e00\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-2021-5683-0975021
Page 100 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time (US
& Canada)
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975022
Page 101 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Aug-07-2020
08:36:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/6/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-07-2020
08:36:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
294.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-07-2020
08:36:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3e00\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-2021-5683-0975023
Page 102 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-07-2020
08:36:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
67.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-07-2020
08:36:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-07-2020
08:36:19
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
46.1Initial Entry
7.a
Date Location User Value Reason
Aug-07-2020
08:36:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.7Initial Entry
090177e196ae3e00\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-2021-5683-0975024
Page 103 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
Y
Aug-07-2020
08:36:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature:
Temperature Unit
:
Temperature Loc
ation::Initial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-07-2020
08:36:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-07-2020
08:36:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.7Initial Entry
090177e196ae3e00\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-2021-5683-0975025
Page 104 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7.a Unit:
Date Location User Value Reason
Aug-07-2020
08:36:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-07-2020
08:36:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975026
Page 105 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-07-2020
08:36:49
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-07-2020
08:36:49
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-07-2020
08:36:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/6/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975027
Page 106 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-07-2020
08:36:49
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-07-2020
08:36:49
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-07-2020
08:36:49
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogona
dotropin Bet
a_PX113
Result:: NEGATIVE
Not Done:
:Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975028
Page 107 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-07-2020
08:36:49
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-07-2020
08:36:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-07-2020
08:36:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975029
Page 108 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-07-2020
08:37:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/6/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-07-2020
08:37:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
43573Initial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975030
Page 109 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-07-2020
09:38:12
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-07-2020
09:38:12
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-07-2020
09:38:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-07-2020
09:38:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975031
Page 110 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Please review
and correct as
appropriate.
Aug-07-2020
09:38:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/6/2020Initial Entry
5.a
Date Location User Value Reason
Aug-07-2020
09:38:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLFJ6Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-07-2020
09:38:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPLFJ6Initial Entry
5.b
Date Location User Value Reason
Aug-07-2020
09:38:32
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLFJ7Initial Entry
090177e196ae3e00\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-2021-5683-0975032
Page 111 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time (US
& Canada)
5.b Sample ID
Date Location User Value Reason
Aug-07-2020
09:38:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPLFJ7Initial Entry
5.c
Date Location User Value Reason
Aug-07-2020
09:39:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP3SG
WInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-07-2020
09:39:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3SGWInitial Entry
5.d
Date Location User Value Reason
090177e196ae3e00\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-2021-5683-0975033
Page 112 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-07-2020
09:39:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP3SG
XInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-07-2020
09:39:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3SGXInitial Entry
5.e
Date Location User Value Reason
Aug-07-2020
09:39:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP3SG
YInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-07-2020
09:39:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3SGYInitial Entry
090177e196ae3e00\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-2021-5683-0975034
Page 113 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-07-2020
09:37:44
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-07-2020
09:37:44
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-07-2020
09:37:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-07-2020
09:37:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975035
Page 114 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Please review
and correct as
appropriate.
Aug-07-2020
09:37:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/6/2020Initial Entry
5.a
Date Location User Value Reason
Aug-07-2020
09:37:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP3SF
YInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-07-2020
09:37:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP3SFYInitial Entry
090177e196ae3e00\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-2021-5683-0975036
Page 115 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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
Aug-07-2020
08:37:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-07-2020
08:37:37
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-07-2020
08:37:37
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-07-2020
08:37:37ACV0PFEINFP6000 Data Entry:
Aug/6/2020 15:01Initial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975037
Page 116 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)
5. Anatomical Location:
Date Location User Value Reason
Aug-07-2020
08:37:37
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-07-2020
08:37:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-07-2020
08:37:37
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975038
Page 117 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-07-2020
08:37:37
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEC
IFIED OBSERVATION
PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-07-2020
08:37:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975039
Page 118 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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
Aug-07-2020
08:37:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975040
Page 119 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020
08:08:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0975041
Page 120 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
V
E
R
Were fever or syst
emic symptoms pr
esent on the last da
y the Subject Diar
y was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
090177e196ae3e00\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-2021-5683-0975042
Page 121 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada)
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
UE
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed?
:N
OInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0975043
Page 122 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.b Symptom:
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or syst
emic symptoms p
resent on the last
day the Subject D
iary was complete
d?:NOInitial Entry
090177e196ae3e00\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-2021-5683-0975044
Page 123 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.c Symptom:
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
LL
S
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed?
:N
OInitial Entry
090177e196ae3e00\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-2021-5683-0975045
Page 124 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.d Symptom:
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:NOInitial Entry
090177e196ae3e00\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-2021-5683-0975046
Page 125 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.e Symptom:
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-10-2020
04:56:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Site: SUBJECT
ANSWERED
"YES' TO
VOMITING ON
LAST DAY OF
DIARY BY
ACCIDENT.
SUBJECT DID
NOT
EXPERIENCE
VOMITING ON
LAST DAY OF
DIARY. A DCF
SUBMITTED
TO TRIAL
MANAGER TO
CORRECT
ANSWER.
Sep-09-2020
08:29:42
(UTC-06:00)ACV0PFEINFP6000 Query 1: Answered SUBJECT
ANSWERED
"YES' TO
090177e196ae3e00\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-2021-5683-0975047
Page 126 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time (US
& Canada)VOMITING ON
LAST DAY OF
DIARY BY
ACCIDENT.
SUBJECT DID
NOT
EXPERIENCE
VOMITING ON
LAST DAY OF
DIARY. A DCF
SUBMITTED
TO TRIAL
MANAGER TO
CORRECT
ANSWER.
Sep-01-2020
12:25:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened e-Diary: Per
eDiary records,
VOMITING is
reported on Last
day (Day 7)
however the last
day in inform is
entered as 'No'
for the same.
Please verify
and update.
Else, clarify.
Thanks
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0975048
Page 127 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.f
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or syst
emic symptoms p
resent on the last
day the Subject D
iary was complete
d?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e00\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-2021-5683-0975049
Page 128 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.g
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PAI
N
Were fever or
systemic symp
toms present o
n the last day
the Subject Di
ary was compl
eted?:NOInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0975050
Page 129 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.g Symptom:
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED
MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAINInitial Entry
090177e196ae3e00\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-2021-5683-0975051
Page 130 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:NO
2.h Symptom:
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED
JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US &ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0975052
Page 131 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Canada)
4. Injection Site Body Side:
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Rea
ction::RE
D
NE
SS
Were injection sit
e reactions presen
t on the last day t
he Subject Diary
was completed?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
090177e196ae3e00\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-2021-5683-0975053
Page 132 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada)
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Re
action::SW
EL
LIN
G
Were injection sit
e reactions prese
nt on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0975054
Page 133 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::PAIN
AT I
NJEC
TION
SITE
Were injection
site reactions pr
esent on the last
day the Subject
Diary was com
pleted?:NOInitial Entry
090177e196ae3e00\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-2021-5683-0975055
Page 134 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION S
ITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
08:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0975056
Page 135 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020
08:09:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2.a
Date Location User Value Reason
Aug-31-2020
08:09:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Iden
tifier::1
Temperature
:98.7
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-31-2020
08:09:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3e00\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-2021-5683-0975057
Page 136 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.a Temperature:
Date Location User Value Reason
Aug-31-2020
08:09:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.7Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-31-2020
08:09:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Aug-31-2020
08:09:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e00\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-2021-5683-0975058
Page 137 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-31-2020
08:09:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-31-2020
08:09:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-31-2020
08:09:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0975059
Page 138 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-31-2020
08:09:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-31-2020
08:09:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-31-2020
08:09:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogona
dotropin Bet
a_PX113
Result:: NEGATIVE
Not Done:
:Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975060
Page 139 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-31-2020
08:09:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-31-2020
08:09:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Bet
a_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-31-2020
08:09:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0975061
Page 140 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020
08:12:24
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020
08:12:24
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020
08:12:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-31-2020
08:12:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975062
Page 141 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
review and
correct as
appropriate.
Aug-31-2020
08:12:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020
08:12:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYKJ1Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020
08:12:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPYKJ1Initial Entry
090177e196ae3e00\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-2021-5683-0975063
Page 142 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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
Aug-31-2020
08:10:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020
08:10:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020
08:10:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020
08:10:06ACV0PFEINFP6000 Data Entry:
Aug/27/2020 07:48Initial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0975064
Page 143 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020
08:10:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020
08:10:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-31-2020
08:10:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0975065
Page 144 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-31-2020
08:10:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEC
IFIED OBSERVATION
PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-31-2020
08:10:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0975066
Page 145 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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-30-2020
07:15:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/29/2020Initial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975067
Page 146 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-30-2020
07:15:50ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
090177e196ae3e00\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-2021-5683-0975068
Page 147 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae3e00\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-2021-5683-0975069
Page 148 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.b Symptom:
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:NOInitial Entry
090177e196ae3e00\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-2021-5683-0975070
Page 149 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.c Symptom:
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
L
LS
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
090177e196ae3e00\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-2021-5683-0975071
Page 150 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.d Symptom:
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:NOInitial Entry
090177e196ae3e00\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-2021-5683-0975072
Page 151 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.e Symptom:
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:N
OInitial Entry
090177e196ae3e00\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-2021-5683-0975073
Page 152 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.f Symptom:
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AINInitial Entry
090177e196ae3e00\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-2021-5683-0975074
Page 153 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
2.g Symptom:
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
Symptom:: NEWInitial Entry
090177e196ae3e00\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-2021-5683-0975075
Page 154 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time (US
& Canada)OR W
ORSE
NED J
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary w
as completed
?:NO
2.h Symptom:
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975076
Page 155 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::RE
D
NE
SS
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:N
OInitial Entry
5.a Injection Site Reaction:
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975077
Page 156 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NOInitial Entry
090177e196ae3e00\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-2021-5683-0975078
Page 157 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITEInitial Entry
090177e196ae3e00\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-2021-5683-0975079
Page 158 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were injectio
n site reaction
s present on t
he last day th
e Subject Dia
ry was compl
eted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
07:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975080
Page 159 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020
13:57:56
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020
13:57:56
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-30-2020
13:58:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-30-2020
13:57:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975081
Page 160 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Please review
and correct as
appropriate.
Sep-30-2020
13:57:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/29/2020Initial Entry
5.a
Date Location User Value Reason
Sep-30-2020
13:58:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPYDV
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-30-2020
13:58:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPYDVRInitial Entry
5.b
Date Location User Value Reason
Oct-01-2020
13:40:57
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPL4Z
WInitial Entry
090177e196ae3e00\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-2021-5683-0975082
Page 161 of 206
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time (US
& Canada)
5.b Sample ID
Date Location User Value Reason
Oct-01-2020
13:40:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPL4ZWInitial Entry
5.c
Date Location User Value Reason
Oct-01-2020
13:41:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPL506Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-01-2020
13:41:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPL506Initial Entry
090177e196ae3e00\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-2021-5683-0975083
Page 162 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit
on Aug/10/2020Form: 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: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-13-2020
09:15:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975084
Page 163 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit
on Aug/10/2020Form: UNPLANNED VISIT - 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: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Assessments
Date Location User Value Reason
Aug-13-2020
09:18:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-13-2020
09:15:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Contact
Outcome is
ticked however
'CONTACT
OUTCOME'
form is not
entered. Please
review and
update as
appropriate.
Aug-13-2020
09:15:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCO
MEInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975085
Page 164 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit
on Aug/10/2020Form: CONTACT OUTCOME - UNPLANNED - 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: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Contact Type:
Date Location User Value Reason
Aug-13-2020
09:18:36
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Aug-13-2020
09:18:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Aug/10/2020
Contact Outcome:
VISIT NOT REQUI
RED, INVESTIGA
TOR DECISIONInitial Entry
3. Comments:
Date Location User Value Reason
Aug-13-2020
09:28:57
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
SUBJECT STATES S
HE TOOK HER TE
MPERATURE 08AUTranscription
Error
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975086
Page 165 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit
on Aug/10/2020Form: CONTACT OUTCOME - UNPLANNED - 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: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada) G2020 WHEN SHE
WAS OUTSIDE IN T
HE HEAT (103.3F).
WHEN SHE REPEA
TED IT INSIDE AN
HOUR LATER AFT
ER NOT TAKING A
NY MEDICATION I
T WAS 98.3F.
Aug-13-2020
09:18:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SUBJECT STATES S
HE TOOK HER TE
MPERATURE WHE
N SHE WAS OUTSI
DE IN THE HEAT.
WHEN SHE REPEA
TED IT AN HOUR L
ATER AFTER NOT
TAKING ANY MED
ICATION IT WAS 98
.3F. SHE CONFIRM
S USING PROVIDE
D THERMOMETER.Initial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975087
Page 166 of 206
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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-30-2020
13:57:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-30-2020
13:57:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-30-2020
13:57:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975088
Page 167 of 206
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 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
Dec-02-2020
16:15:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-02-2020
16:15:43
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Dec-09-2020
19:09:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Dec-08-2020
14:18:38
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Query 1: Answered PI withdrew the
subject due to
being unreliable,
erratic in
090177e196ae3e00\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-2021-5683-0975089
Page 168 of 206
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada) behavior and
showing a
pattern of
reporting
erroneous
information.
Dec-03-2020
20:18:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery:
Please can you
confirm what the
primary reason
for
discontinatuion
for the subject
was? If this is
related to an AE,
please update as
appropriate.
Thanks
Dec-02-2020
16:15:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PHYSICIAN DECIS
IONInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975090
Page 169 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Nov-16-2020
07:57:51
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975091
Page 170 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Jan-13-2021
10:55:39
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975092
Page 171 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020
07:57:51
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020
07:57:51
(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-14-2021
23:00:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 9: Closed Response satisfies
query
Jan-14-2021
22:46:11
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 8: Closed Response satisfies
query
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975093
Page 172 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Jan-13-2021
10:53:58
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 9: Answe
redUpdating per
query
Jan-13-2021
10:53:58
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 8: Answe
redUpdating per
query
Jan-13-2021
10:53:58
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MICROCYTIC
ANEMIAUpdating per
query
Jan-11-2021
15:46:58
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 9: Opene
dCLINICAL Please
consider splitting
the AE/SAE event
term into
'Microcytic
Anemia' and
'Abnormal RBC
Morphology
including Sickle
Cells', which has
been reviewed for
successful coding.
Thank You.
Jan-05-2021
07:44:27
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 8: Opene
dSAE RECON:
AER#2020450795,
the current
verbatim codes to
3 event terms in
090177e196ae3e00\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-2021-5683-0975094
Page 173 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Safety database.
Please clarify
event term ad if a
singular diagnosis
can be provided.
Dec-11-2020
14:37:20
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 7: Closed Response satisfies
query
Dec-10-2020
10:02:15
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MICROCYTIC
ANEMIA WIT
H ABNORMA
L RBC MORPH
OLOGY INCL
UDING SICKL
E CELLSCHANGED PER
QUERY
Dec-10-2020
09:54:54
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 7: Answe
redWILL UPDATE
Dec-07-2020
12:47:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 7: Opene
dClinical SAE
report gives
hematology report
of subject's anemia
as "microcytic
anemia with
abnormal RBC
morphology
including sickle
cells." Please
090177e196ae3e00\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-2021-5683-0975095
Page 174 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
review this more
detailed event
description, and
update event term
if appropriate
Dec-06-2020
19:16:53
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 6: Closed Response satisfies
query
Dec-03-2020
10:48:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 6: Answe
redSubject received
red blood cells.
Dec-02-2020
19:26:39
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 6: Opene
dClinQuery:
MICROCYTIC
ANEMIA: please
can you confirm if
subject was given
any bloods or
prohibited
medication as a
result of this AE?
Thanks
Dec-02-2020
16:47:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 5: Closed Response satisfies
query
Dec-02-2020
16:47:11ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
090177e196ae3e00\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-2021-5683-0975096
Page 175 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time
(US & Canada)
Dec-02-2020
16:43:45
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Dec-02-2020
16:14:31
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answe
redThe even of illicit
drug use is in our
source, but does
not meet protocol
reporting
timelines.
Dec-02-2020
10:48:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answe
redNew SAE update
faxed on
01DEC2020
Dec-02-2020
10:48:22
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 5: Answe
redSubject left AMA
before any workup
could be done, her
status is unknown.
Dec-01-2020
20:38:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Reissu
ed:OpenedClinical - On
review of the SAE
report for Anemia,
an event of illicit
drug use (Cocaine)
has been
mentioned, yet it
does not appear in
090177e196ae3e00\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-2021-5683-0975097
Page 176 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
the CRF. Please
review for safety
and update AE log
CRF accordingly.
Dec-01-2020
20:38:11
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissu
ed:OpenedCLINICAL -
please submit a
SAE safety update
that describes the
signs and
symptoms that
prompted the
subject to go to
Emergency
Dec-01-2020
20:37:52
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 5: Reissu
ed:OpenedCLINICAL - SAE
report for SAE
Anemia states that
subject's mother
had sickle cell
anemia, and
subject's blood
smear reports
abnormal RBCs.
Please update with
subject's status as
sickle cell trait,
sickle cell
homozygous, or
other genetic
profle
Dec-01-2020
20:28:00
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed splenomegaly AE
would have onset
after visit 3
090177e196ae3e00\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-2021-5683-0975098
Page 177 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Dec-01-2020
20:24:27
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Dec-01-2020
14:12:34
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Answe
redPER QUERY
RESOLUTION
Dec-01-2020
14:12:34
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Answe
redPER QUERY
RESOLUTION
Dec-01-2020
14:12:34
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answe
redPER QUERY
RESOLUTION
Dec-01-2020
14:12:34
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answe
redPER QUERY
RESOLUTION
Dec-01-2020
14:12:34
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answe
redPER QUERY
RESOLUTION
Dec-01-2020 ACV0PFEINFP6000 Data Entry: PER QUERY
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975099
Page 178 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
14:12:34
(UTC-06:00)
Central Time
(US & Canada)MICROCYTIC
ANEMIARESOLUTION
Nov-25-2020
13:48:42
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: Opene
dCLINICAL SAE
report for the SAE
of Anemia
specifies that
subject has
microcytic anemia;
consider updating
to this more
specific term in
AE CRF and SAE
report
Nov-25-2020
13:20:12
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 5: Opene
dCLINICAL - SAE
report for SAE
Anemia states that
subject's mother
had sickle cell
anemia, and
subject's blood
smear reports
abnormal RBCs.
Please update with
subject's status as
sickle cell trait,
sickle cell
homozygous, or
other genetic
profle
Nov-25-2020
13:17:49
(UTC-06:00)ACV0PFEINFP6000 Query 4: Candid
ateCLINICAL SAE
report for the SAE
of Anemia
090177e196ae3e00\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-2021-5683-0975100
Page 179 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time
(US & Canada)specifies that
subject has
microcytic anemia;
consider updating
to this more
specific term in
AE CRF and SAE
report
Nov-25-2020
13:15:25
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opene
dClinical - On
review of the SAE
report for Anemia,
an event of illicit
drug use (Cocaine)
has been
mentioned, yet it
does not appear in
the CRF. Please
review for safety
and update AE log
CRF accordingly.
Nov-25-2020
13:13:21
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opene
dCLINICAL -
please submit a
SAE safety update
that describes the
signs and
symptoms that
prompted the
subject to go to
Emergency
Nov-19-2020
14:14:29
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opene
dClinical On review
of the SAE report
for Anemia, an
event of
Splenomegaly has
090177e196ae3e00\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-2021-5683-0975101
Page 180 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
been mentioned,
yet it does not
appear in the CRF.
Please review for
safety and update
AE log CRF
accordingly.
Nov-16-2020
15:25:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ANEMIAChanged
Information
Nov-16-2020
07:57:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SPLENOMEG
ALYInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-16-2020
19:10:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Dec-16-2020
09:58:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered Source has
detailed
comments, per
PI no SAE
follow-up
comment needed
090177e196ae3e00\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-2021-5683-0975102
Page 181 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Dec-11-2020
14:41:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Dec-11-2020
14:40:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL
Thank you.
Consider a SAE
followup
comment on the
site's experience
during this
period.
Dec-08-2020
14:25:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered We saw the
subject during
this "2 month"
time frame and
she did not
present with any
of these
symptoms nor
report them to
us. When we
read them to her
off of the
medical records
she said she
doesn't
remember any
of that.
Dec-07-2020
12:44:21
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Query 1: Opened CLINICAL
Please review
start date based
on SAE
090177e196ae3e00\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-2021-5683-0975103
Page 182 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada) "presented to ER
with a 2-month
hx of SOB on
exertion, diffuse
abd pain,
unsteady gait,
generalized
weakness &
fatigue
progressively
getting worse"
SAE start date
can include days
prior to
Hospitalization
too
Nov-16-2020
07:57:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/9/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-09-2020
06:34:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Dec-08-2020
14:36:02
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Query 1: Answered Subject was
withdrawn
from the study
and last we
090177e196ae3e00\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-2021-5683-0975104
Page 183 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada) knew the AE
was still
ongoing
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975105
Page 184 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-04-2020
02:41:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:O
penedDM: Adverse
Event is still
ongoing but
'Disposition
Follow-up form
details are
completed.
Please review
and update as
appropriate.
Dec-02-2020
16:16:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered The last
information that
we have shows
that the AE is
still ongoing
Dec-02-2020
16:15:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form
is completed
and this
Adverse Event
is still ongoing.
Please review
and update as
appropriate.
Nov-16-2020
14:28:32
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
YESTranscription
Error
090177e196ae3e00\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-2021-5683-0975106
Page 185 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada)
Nov-16-2020
07:57:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/11/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020
07:57:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical
event (i.e. may jeopardize subject and may require medical/surgical intervention to prevent above
outcomes).
Date Location User Value Reason
Dec-11-2020
14:36:17
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
090177e196ae3e00\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-2021-5683-0975107
Page 186 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Dec-10-2020
10:01:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answer
edWILL UPDATE
TODAY
Dec-07-2020
12:45:14
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical Please
update the SAE
with start and stop
dates of
hospitalization
Dec-01-2020
20:26:52
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Dec-01-2020
14:53:20
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answer
edWill include the
results of hospital
obtained
COVID-19 testing
in the next
follow-up SAE
form
Nov-19-2020
14:13:37
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL COVID
test status (yes/no)
during Hosp was
not reported in the
SAE. Please submit
a follow-up SAE
form
[#2020450795] to
document if
COVID testing was
performed
090177e196ae3e00\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-2021-5683-0975108
Page 187 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(YES/NO or info
not available) and if
yes, the date and
results.
Nov-16-2020
10:34:30
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-16-2020
07:57:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candid
ateFor AE
SPLENOMEGALY:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Nov-16-2020
07:57:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious e
vent associated
with congenital
anomaly or birt
h defect?
NO
Did this serious
event result in d
eath?
NOInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975109
Page 188 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Did this serious
event require or
prolong hospita
lization?
YES
Did this serious
event result in p
ersistent or sign
ificant disabilit
y/incapacity?
NO
Is this serious e
vent life threate
ning?
NO
Other medicall
y important seri
ous event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-16-2020
07:57:51
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975110
Page 189 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-16-2020
15:27:31
(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:
UNKNOWNNew
Information
Nov-16-2020
07:57:51
(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:
UNKNOWN,
WAITING ON
MEDICAL RE
CORD REVIE
WInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975111
Page 190 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Nov-16-2020
07:57:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-16-2020
15:27:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-16-2020
15:27:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Nov-17-2020
09:46:40
(UTC-06:00)
Central TimeACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
090177e196ae3e00\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-2021-5683-0975112
Page 191 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US &
Canada)
Nov-17-2020
07:57:46
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dconfirmed not recovered/ not
resolved. Subject was discharged/
left the hosptial against medical
advice. The last hemoglobin levels
on record are in the "7" range.
Nov-17-2020
07:17:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Open
edOutcome updated in both database to
not recovered/not resolved
Nov-16-2020
17:31:16
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Candi
datePending SDB udpate
Nov-16-2020
14:28:32
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Clo
sedClose Auto Query
Nov-16-2020
14:28:08
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Op
enedFor AE SPLENOMEGALY:
Response to "What was the outcome
of this adverse event?" is 'Not
Recovered/Not Resolved' but AE
End Date/Time is present.
090177e196ae3e00\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-2021-5683-0975113
Page 192 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Nov-16-2020
14:28:08
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Nov-16-2020
14:28:08
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NOT
REC
OVE
RED/
NOT
RESO
LVE
DTranscription Error
Nov-16-2020
10:35:37
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Op
enedSAE
RECON:AER#2020450795,outcome
was reported as UNKNOWN to
Safety DB however, recorded as
RECOVERED/RESOLVED AE
CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Nov-16-2020
07:57:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
REC
OVE
RED/
RESOInitial Entry
090177e196ae3e00\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-2021-5683-0975114
Page 193 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
LVE
D
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020
07:57:51
(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
Nov-16-2020
10:34:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2020450795Initial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0975115
Page 194 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Jan-13-2021
10:55:39
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-13-2021
10:55:39
(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
14:14:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Samuel
DychterQuery 1: Closed Response
satisfies query
Jan-25-2021
15:24:53
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Query 1: Answered no
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0975116
Page 195 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada)
Jan-20-2021
18:37:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Samuel
DychterQuery 1: Opened GPD Clin:
Does the
subject have a
history of
sickle cell
disease?
Jan-13-2021
10:55:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ABNORMAL RBC M
ORPHOLOGY INCL
UDING SICKLE CEL
LSInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-13-2021
10:55:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/9/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-14-2021
15:14:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Jan-13-2021
10:55:56ACV0PFEINFP6000 Query 1: Answered CORRECT
AS IS
090177e196ae3e00\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-2021-5683-0975117
Page 196 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-06:00)
Central Time (US
& Canada)
Jan-13-2021
10:55:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up
form is
completed and
this Adverse
Event is still
ongoing.
Please review
and update as
appropriate.
Jan-13-2021
10:55:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-13-2021
10:55:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
3Initial 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
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975118
Page 197 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
event (i.e. may jeopardize subject and may require medical/surgical intervention to prevent above
outcomes).
Date Location User Value Reason
Jan-14-2021
22:45:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be
addressed
internally
Jan-13-2021
10:55:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
ABNORMAL
RBC
MORPHOLOGY
INCLUDING
SICKLE CELLS:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Jan-13-2021
10:55:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious even
t associated with c
ongenital anomaly
or birth defect?
NO
Did this serious ev
ent result in death?Initial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975119
Page 198 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
NO
Did this serious ev
ent require or prolo
ng hospitalization?
YES
Did this serious ev
ent result in persist
ent or significant d
isability/incapacity
?
NO
Is this serious even
t life threatening?
NO
Other medically i
mportant serious e
vent
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-13-2021
10:55:39
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975120
Page 199 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
& Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-13-2021
10:55:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this ev
ent is due to:
OTHER
If Other, specify:
UNKNOWNInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-13-2021
10:55:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-13-2021
10:55:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e00\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-2021-5683-0975121
Page 200 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-13-2021
10:55:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-13-2021
10:55:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/N
OT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-13-2021
10:55:39
(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
Jan-14-2021
22:45:54
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
2020450795Initial Entry
090177e196ae3e00\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-2021-5683-0975122
Page 201 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Central Time (US
& Canada)
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975123
Page 202 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Dec-03-2020
11:04:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975124
Page 203 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - 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: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Transfusion Type:
Date Location User Value Reason
Dec-03-2020
11:04:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PACKED RBCInitial Entry
2. Date of Transfusion:
Date Location User Value Reason
Dec-03-2020
11:04:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975125
Page 204 of 206
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-02-2020
16:15:43
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Sep-30-2020
13:57:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-07-2020
08:37:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOM
IZEDInitial Entry
Aug-07-2020
08:34:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-02-2020
16:15:43
(UTC-06:00)
Central Time (US &ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/18/2020Initial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975126
Page 205 of 206
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Canada)
Sep-30-2020
13:57:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/29/2020Initial Entry
Aug-07-2020
08:37:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/6/2020Initial Entry
Aug-07-2020
08:34:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/6/2020Initial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975127
Page 206 of 206
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-09-2020
15:42:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e00\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975128