Document text
Page 1 of 372
***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: 11071044 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
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974551
Page 2 of 372
***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: 11071044 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/5/2020
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974552
Page 3 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [11071044]
2.Birth Date: /1959
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0974553
Page 4 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/5/2020
2.Erroneous Visit
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974554
Page 5 of 372
***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: 11071044 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
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974555
Page 6 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/5/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974556
Page 7 of 372
***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: 11071044 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:[DEPRESSION]
Start Date: Jan/UNK/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TUBAL LIGATION]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SEASONAL ALLERGIES]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[INSOMNIA]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974557
Page 8 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CHRONIC RIGHT UPPER QUADRANT PAIN]
Start Date: Mar/UNK/2020
Ongoing: NO
End Date:
Sep/12/2020
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GASTROESOPHAGEAL REFLUX DISEASE]
Start Date: UNK/UNK/2015
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MENORRHAGIA]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYSTERECTOMY]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974558
Page 9 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Aug/5/2020
2.Weight: [240.6]
3.Unit: LB
4.Height: [67.5]
5.Unit: in
6.Body Mass Index: [37.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974559
Page 10 of 372
***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: 11071044 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/5/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974560
Page 11 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/5/2020
2.Randomization Number: [222623]
3.Randomization Group: [ ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974561
Page 12 of 372
***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: 11071044 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/5/2020
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 [BP3SDB]
5.bSample ID [BP3SDC]
5.cSample ID [BP3SDD]
5.dSample ID [BPLFHH]
5.eSample ID [BPLFHJ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974562
Page 13 of 372
***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: 11071044 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/5/2020
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 [BP3SDH]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974563
Page 14 of 372
***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: 11071044 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/5/2020 11:28
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974564
Page 15 of 372
***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: 11071044 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
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974565
Page 16 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974566
Page 17 of 372
***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: 11071044 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
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?YES
Ongoing?
NO
Stop Date:
Aug/11/2020
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974567
Page 18 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
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
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974568
Page 19 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974569
Page 20 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974570
Page 21 of 372
***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: 11071044 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/26/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYKHP]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974571
Page 22 of 372
***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: 11071044 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/26/2020 14:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974572
Page 23 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974573
Page 24 of 372
***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: 11071044 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
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
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974574
Page 25 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
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
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974575
Page 26 of 372
***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: 11071044 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/23/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPL4WV]
5.bSample ID [BPL4X2]
5.cSample ID [BPYDSX]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974576
Page 27 of 372
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974577
Page 28 of 372
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 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:
Feb/18/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRVVW7]
5.bSample ID [BRVVWK]
5.cSample ID [BRMWVL]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974578
Page 29 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974579
Page 30 of 372
***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: 11071044 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 [ ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974580
Page 31 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974581
Page 32 of 372
***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: 11071044 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 [ ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974582
Page 33 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974583
Page 34 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/4/2021
2.Date of First Symptom Started: Feb/4/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/11/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974584
Page 35 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Locat
ionAssay Code and Descript
ionDevice Type Form Instance
1.Not Applicable Not Applicabl
e Not Applicable Not Applicable Not Applicabl
e Repeating
Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974585
Page 36 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974586
Page 37 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 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_SELF
3.Sample Collected? YES
Date of Collection:
Feb/4/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW85684]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974587
Page 38 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Self Swab]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974588
Page 39 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974589
Page 40 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicabl
e Not Applicabl
e Not Applicabl
e Repeating
Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974590
Page 41 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974591
Page 42 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974592
Page 43 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974593
Page 44 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974594
Page 45 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for La
b TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applic
able Not Applica
ble Not Applic
able Sponsor-Defined I
dentifierTest: Result:
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able Repeating
Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974595
Page 46 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974596
Page 47 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974597
Page 48 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974598
Page 49 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974599
Page 50 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable
Not Applicable Not Applic
able Not Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974600
Page 51 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974601
Page 52 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974602
Page 53 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974603
Page 54 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974604
Page 55 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974605
Page 56 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974606
Page 57 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974607
Page 58 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974608
Page 59 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974609
Page 60 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974610
Page 61 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974611
Page 62 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974612
Page 63 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974613
Page 64 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974614
Page 65 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974615
Page 66 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974616
Page 67 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Mar/11/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974617
Page 68 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Mar/11/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 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:
Mar/11/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMWXF]
5.bSample ID [BRVVZL]
5.cSample ID [BRVVZH]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974618
Page 69 of 372
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974619
Page 70 of 372
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974620
Page 71 of 372
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 11071044 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/28/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Severe fever, chills and fatigue resolved after one day. Subject took medication and is
feeling much better, no need for visit.]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974621
Page 72 of 372
***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: 11071044 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/23/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974622
Page 73 of 372
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974623
Page 74 of 372
***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: 11071044 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:
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974624
Page 75 of 372
***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: 11071044 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 [ ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974625
Page 76 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
1.ADVERSE EVE
NT 1 CHOLELITHIAS
IS Sep/11/2020 UNK:U
NK NO
End Date Time:
Sep/15/2020 UNK:UNK
Repeating
Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974626
Page 77 of 372
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 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)[CHOLELITHIASIS]
4.Start Date Time: Sep/11/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/15/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
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
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974627
Page 78 of 372
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020371056]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974628
Page 79 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974629
Page 80 of 372
***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: 11071044 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[ ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974630
Page 81 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
1. Repeating
Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974631
Page 82 of 372
***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: 11071044 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: //
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974632
Page 83 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974633
Page 84 of 372
***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: 11071044 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?
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974634
Page 85 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974635
Page 86 of 372
***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: 11071044 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?
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974636
Page 87 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974637
Page 88 of 372
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974638
Page 89 of 372
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974639
Page 90 of 372
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 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:
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974640
Page 91 of 372
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 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:
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974641
Page 92 of 372
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 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?
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974642
Page 93 of 372
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974643
Page 94 of 372
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974644
Page 95 of 372
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled 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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974645
Page 96 of 372
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974646
Page 97 of 372
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled 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: 11071044 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 [ ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974647
Page 98 of 372
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 11071044 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 [ ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974648
Page 99 of 372
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974649
Page 100 of 372
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974650
Page 101 of 372
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/15/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974651
Page 102 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974652
Page 103 of 372
***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: 11071044 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: [ ]
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974653
Page 104 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/23/2020
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974654
Page 105 of 372
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 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
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974655
Page 106 of 372
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Harry Studdard Approved Mar-12-2021 10:33:18 (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.
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0974656
Page 107 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormAug-05-2020 13:58:55 (UTC-06:00) Central Time
(US & Canada)SUBJECT MET ALL INC/EXC CRITERIA
Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974657
Page 108 of 372
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormAug-26-2020 15:07:21 (UTC-06:00) Central Time
(US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974658
Page 109 of 372
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Aug-26-2020 15:07:21 (UTC-06:00) Central Time
(US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974659
Page 110 of 372
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Aug-26-2020 15:07:21 (UTC-06:00) Central Time
(US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974660
Page 111 of 372
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Aug-26-2020 15:07:21 (UTC-06:00) Central Time
(US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974661
Page 112 of 372
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Aug-26-2020 15:07:21 (UTC-06:00) Central Time
(US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974662
Page 113 of 372
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Aug-26-2020 15:07:21 (UTC-06:00) Central Time
(US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974663
Page 114 of 372
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aAug-26-2020 15:07:21 (UTC-06:00) Central Time
(US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
(
FDA-CBER-2021-5683-0974664
Page 115 of 372
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aAug-26-2020 15:07:21 (UTC-06:00) Central Time
(US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974665
Page 116 of 372
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aAug-26-2020 15:07:21 (UTC-06:00) Central Time
(US & Canada)POST MENOPAUSAL
Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974666
Page 117 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-04-2021 15:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974667
Page 118 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Feb-04-2021 15:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974668
Page 119 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Feb-04-2021 15:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974669
Page 120 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Feb-04-2021 15:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974670
Page 121 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Feb-04-2021 15:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974671
Page 122 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Feb-04-2021 15:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974672
Page 123 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6Feb-04-2021 15:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974673
Page 124 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
7Feb-04-2021 15:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974674
Page 125 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
8Feb-04-2021 15:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974675
Page 126 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
9Feb-04-2021 15:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974676
Page 127 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-04-2021 15:23:56 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974677
Page 128 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Feb-04-2021 15:23:56 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974678
Page 129 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Feb-04-2021 15:23:56 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974679
Page 130 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Feb-04-2021 15:23:56 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974680
Page 131 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Feb-04-2021 15:23:56 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974681
Page 132 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Feb-04-2021 15:23:56 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974682
Page 133 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6Feb-04-2021 15:23:56 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974683
Page 134 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-04-2021 15:24:54 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974684
Page 135 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Feb-04-2021 15:24:54 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974685
Page 136 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Feb-04-2021 15:24:54 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974686
Page 137 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Feb-04-2021 15:24:54 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974687
Page 138 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Feb-04-2021 15:24:54 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974688
Page 139 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974689
Page 140 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Feb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974690
Page 141 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Feb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974691
Page 142 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Feb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974692
Page 143 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Feb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974693
Page 144 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.aFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974694
Page 145 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.aFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974695
Page 146 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.aFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974696
Page 147 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.aFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974697
Page 148 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.bFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974698
Page 149 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.bFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974699
Page 150 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.bFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974700
Page 151 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.bFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974701
Page 152 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.cFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974702
Page 153 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.cFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974703
Page 154 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.cFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974704
Page 155 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.cFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974705
Page 156 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.dFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974706
Page 157 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.dFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974707
Page 158 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.dFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974708
Page 159 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.dFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974709
Page 160 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.eFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974710
Page 161 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.eFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974711
Page 162 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.eFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974712
Page 163 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.eFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974713
Page 164 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.fFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974714
Page 165 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.fFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974715
Page 166 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.fFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974716
Page 167 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.fFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974717
Page 168 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.gFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974718
Page 169 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.gFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974719
Page 170 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.gFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974720
Page 171 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.gFeb-04-2021 15:25:19 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974721
Page 172 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974722
Page 173 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Feb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974723
Page 174 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Feb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974724
Page 175 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Feb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974725
Page 176 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Feb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974726
Page 177 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.aFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974727
Page 178 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.aFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974728
Page 179 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.aFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974729
Page 180 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.aFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974730
Page 181 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.bFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974731
Page 182 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.bFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974732
Page 183 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.bFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974733
Page 184 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.bFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974734
Page 185 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.cFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974735
Page 186 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.cFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974736
Page 187 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.cFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974737
Page 188 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.cFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974738
Page 189 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.dFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974739
Page 190 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.dFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974740
Page 191 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.dFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974741
Page 192 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.dFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974742
Page 193 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.eFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974743
Page 194 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.eFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974744
Page 195 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.eFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974745
Page 196 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.eFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974746
Page 197 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.fFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974747
Page 198 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.fFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974748
Page 199 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.fFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974749
Page 200 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.fFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974750
Page 201 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.gFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974751
Page 202 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.gFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974752
Page 203 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.gFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974753
Page 204 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.gFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974754
Page 205 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.hFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974755
Page 206 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.hFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974756
Page 207 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.hFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974757
Page 208 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.hFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974758
Page 209 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.iFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974759
Page 210 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.iFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974760
Page 211 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.iFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974761
Page 212 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.iFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974762
Page 213 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.jFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974763
Page 214 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.jFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974764
Page 215 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.jFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974765
Page 216 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.jFeb-04-2021 15:25:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974766
Page 217 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-04-2021 15:25:53 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974767
Page 218 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Feb-04-2021 15:25:53 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974768
Page 219 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2.aFeb-04-2021 15:25:53 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974769
Page 220 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2.aFeb-04-2021 15:25:53 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974770
Page 221 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2.aFeb-04-2021 15:25:53 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974771
Page 222 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2.aFeb-04-2021 15:25:53 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974772
Page 223 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-04-2021 15:26:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974773
Page 224 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Feb-04-2021 15:26:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974774
Page 225 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2.aFeb-04-2021 15:26:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974775
Page 226 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-04-2021 15:26:45 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974776
Page 227 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Feb-04-2021 15:26:45 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974777
Page 228 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Feb-04-2021 15:26:45 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974778
Page 229 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Feb-04-2021 15:26:45 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974779
Page 230 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-04-2021 15:27:00 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974780
Page 231 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Feb-04-2021 15:27:00 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974781
Page 232 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Feb-04-2021 15:27:00 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974782
Page 233 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Feb-04-2021 15:27:00 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974783
Page 234 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Feb-04-2021 15:27:00 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974784
Page 235 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Feb-04-2021 15:27:00 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974785
Page 236 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6Feb-04-2021 15:27:00 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974786
Page 237 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-04-2021 15:27:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974787
Page 238 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Feb-04-2021 15:27:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974788
Page 239 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Feb-04-2021 15:27:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974789
Page 240 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Feb-04-2021 15:27:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974790
Page 241 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Feb-04-2021 15:27:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0974791
Page 242 of 372
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Harry Studdard Approved Mar-12-2021 10:33:18 (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 Feb-04-2021 15:21:46 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Harry Studdard Approved Jan-24-2021 19:47:53 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HarryStuddard, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-21-2021 13:55:36 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Harry Studdard Approved Oct-07-2020 14:27:22 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0974792
Page 243 of 372
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1107 Site Name: (1107) Coastal Clinical Research
Subject No: 11071044 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 Sep-24-2020 10:11:45 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Harry Studdard Approved Sep-04-2020 12:46:42 (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.
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0974793
Page 244 of 372
***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: 11071044 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-05-2020 13:56:35
(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-05-2020 13:56:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0974794
Page 245 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-05-2020 13:57:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/5/2020Initial Entry
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0974795
Page 246 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-05-2020 13:56:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11071044Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-05-2020 13:56:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1959Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-05-2020 13:57:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-05-2020 13:57:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-05-2020 13:57:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e04\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-2021-5683-0974796
Page 247 of 372
***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: 11071044 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-05-2020 13:58:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0974797
Page 248 of 372
***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: 11071044 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-05-2020 13:59:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-05-2020 13:59:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-05-2020 13:59:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0974798
Page 249 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.a
Date Location User Value Reason
Aug-05-2020 14:00:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:DEPRESSIO
N
Start Date: Jan/UNK/202
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-05-2020 14:00:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-30-2020 10:18:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Sep-30-2020 03:47:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-29-2020 12:12:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered MED HISTORY
HAS BEEN ADDED
Sep-29-2020 12:12:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered MED HISTORY
HAS BEEN ADDED
Sep-29-2020 08:13:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened ClinQuery - please
re-add Chronic Rt
Upper Quadrant pain
to Med Hx as
pre-existing
(pre-study) condition
with onset in Mar
2020 as per SAE
med Hx [subsequent
090177e196ae3e04\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-2021-5683-0974799
Page 250 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
AE cholelithiasis has
a post-study
diagnosis date].
Sep-29-2020 05:38:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Form unlocked
per site request.
Subject had chronic
right upper quadrant
pain listed on MH, it
has now been
diagnosed as
Cholelithiasis and
removed. Site needs
to update MH term
and add stop date.
Sep-25-2020 14:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine Puig Query 1: Candidate DM: Form unlocked
per site request.
Subject had chronic
right upper quadrant
pain listed on MH, it
has now been
diagnosed as
Cholelithiasis and
removed. Site needs
to update MH term
and add stop date.
Aug-05-2020 14:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DEPRESSIONInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-05-2020 14:00:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-05-2020 14:00:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae3e04\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-2021-5683-0974800
Page 251 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-05-2020 14:00:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
erm:TUBAL LIGATI
ON
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2
000Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-05-2020 14:00:59
(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-05-2020 14:00:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
TUBAL LIGATIONInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-05-2020 14:00:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-05-2020 14:00:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
1.c
Date Location User Value Reason
Aug-05-2020 14:01:23
(UTC-06:00) Central TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb 3Initial Entry
090177e196ae3e04\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-2021-5683-0974801
Page 252 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada) er:
Medical History
Term:SEASONAL ALL
ERGIES
Start Date: UNK/UNK/2018
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-05-2020 14:01:23
(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-05-2020 14:01:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SEASONAL ALLERGIESInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-05-2020 14:01:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-05-2020 14:01:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-05-2020 14:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:INSOMNIA
Start Date: UNK/UNK/20
19
Ongoing: YESInitial Entry
090177e196ae3e04\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-2021-5683-0974802
Page 253 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.d Line/MH Number:
Date Location User Value Reason
Aug-05-2020 14:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-05-2020 14:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
INSOMNIAInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-05-2020 14:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-05-2020 14:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-29-2020 12:11:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical Hi
story Term:CHRONIC RIGHT UPP
ER QUADRANT PAIN
Start Date: Mar/UNK/2020
Ongoing: NO
End Date:
Sep/12/2020Initial Entry
090177e196ae3e04\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-2021-5683-0974803
Page 254 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.e Line/MH Number:
Date Location User Value Reason
Sep-29-2020 12:11:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020 12:11:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHRONIC RIGHT UPPER QUADR
ANT PAINInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-29-2020 12:11:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/UNK/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-29-2020 12:11:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Sep/12/2020Initial Entry
1.f
Date Location User Value Reason
Sep-29-2020 12:32:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical His
tory Term:GASTROESOPHAGE
AL REFLUX DISEASE
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
090177e196ae3e04\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-2021-5683-0974804
Page 255 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.f Line/MH Number:
Date Location User Value Reason
Sep-29-2020 12:32:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020 12:32:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
GASTROESOPHAGEAL REFLUX
DISEASEInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-29-2020 12:32:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-29-2020 12:32:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-29-2020 12:33:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Te
rm:MENORRHAGI
A
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2
000Initial Entry
090177e196ae3e04\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-2021-5683-0974805
Page 256 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.g Line/MH Number:
Date Location User Value Reason
Sep-29-2020 12:33:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020 12:33:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MENORRHAGIAInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-29-2020 12:33:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-29-2020 12:33:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
1.h
Date Location User Value Reason
Sep-29-2020 12:34:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Te
rm:HYSTERECTO
MY
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2
000Initial Entry
090177e196ae3e04\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-2021-5683-0974806
Page 257 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.h Line/MH Number:
Date Location User Value Reason
Sep-29-2020 12:34:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020 12:34:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HYSTERECTOMYInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-29-2020 12:34:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-29-2020 12:34:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
090177e196ae3e04\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-2021-5683-0974807
Page 258 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Aug-05-2020 14:02:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-05-2020 14:02:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
240.6Initial Entry
3. Unit:
Date Location User Value Reason
Aug-05-2020 14:02:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-05-2020 14:02:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
67.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-05-2020 14:02:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-05-2020 14:02:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
37.1Initial Entry
7.a
090177e196ae3e04\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-2021-5683-0974808
Page 259 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-05-2020 14:02:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.6
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
Aug-05-2020 14:02:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature:
Temperature Unit:
Temperature Location::Initial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-05-2020 14:02:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-05-2020 14:02:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-05-2020 14:02:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-05-2020 14:02:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e04\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0974809
Page 260 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-05-2020 14:02:52
(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-05-2020 14:02:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-05-2020 14:02:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-05-2020 14:02:52
(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-05-2020 14:02:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-05-2020 14:02:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113Initial Entry
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0974810
Page 261 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Aug-05-2020 14:02:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-05-2020 14:02:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-05-2020 14:02:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0974811
Page 262 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-10-2020 02:22:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-07-2020 07:33:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Aug-07-2020 03:12:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened IVRS Reconciliation:
Randomization
Number (222623)
recorded at impala is
not matching with
number entered in
Inform. Please review
and update data as
appropriate. Else,
clarify. Thank you.
Aug-05-2020 14:03:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
2. Randomization Number:
Date Location User ValueReason
Aug-07-2020
12:23:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_DS001_07
Aug-07-2020
07:33:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
22262
3Transcription Error
Aug-06-2020
07:09:35
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000 Query
1: Ans
weredWE ARE SITE 1107. OUR
SUBJECTS 11071044 AND
11071033 DO NOT HAVE
DUPLICATE RAND.
NUMBERS. :)
090177e196ae3e04\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),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0974812
Page 263 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Canada)
Aug-06-2020
01:46:13
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW4110246;Randomization
Number appears to be a
duplicate with Subject
11201033. Please confirm the
number has been entered
correctly or clarify.
Aug-05-2020
14:03:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
22226
3Initial Entry
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0974813
Page 264 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-05-2020 15:50:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-05-2020 15:50:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-05-2020 15:50:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-05-2020 15:50:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-05-2020 15:50:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/5/2020Initial Entry
5.a
Date Location User Value Reason
Aug-05-2020 15:50:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3SDBInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0974814
Page 265 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-05-2020 15:50:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP3SDBInitial Entry
5.b
Date Location User Value Reason
Aug-05-2020 15:50:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3SDCInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-05-2020 15:50:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP3SDCInitial Entry
5.c
Date Location User Value Reason
Aug-05-2020 15:50:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3SDDInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-05-2020 15:50:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP3SDDInitial Entry
5.d
Date Location User Value Reason
Aug-05-2020 15:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLFHHInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-05-2020 15:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPLFHHInitial Entry
090177e196ae3e04\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),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0974815
Page 266 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.e
Date Location User Value Reason
Aug-05-2020 15:51:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLFHJInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-05-2020 15:51:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPLFHJInitial Entry
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0974816
Page 267 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-05-2020 15:49:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-05-2020 15:49:57
(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-05-2020 15:50:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-05-2020 15:49:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-05-2020 15:49:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/5/2020Initial Entry
5.a
Date Location User Value Reason
Aug-05-2020 15:50:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3SDHInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0974817
Page 268 of 372
***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: 11071044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-05-2020 15:50:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP3SDHInitial Entry
090177e196ae3e04\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0974818
Page 269 of 372
***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: 11071044 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-05-2020 14:03:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-05-2020 14:03:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYI
…[truncated]