Document text
Page 1 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784713
Page 2 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/4/2020
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784714
Page 3 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10161042]
2.Birth Date: /1962
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:
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784715
Page 4 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/4/2020
2.Erroneous Visit
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784716
Page 5 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784717
Page 6 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784718
Page 7 of 433
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Arthritis]
Start Date: Sep/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[B12 Deficiency]
Start Date: Sep/UNK/2018
Ongoing: YES
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784719
Page 8 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/4/2020
2.Weight: [190.2]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [28.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784720
Page 9 of 433
***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, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/4/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113] Comments
Test: Choriogonadotropin Beta_PX113
Result: Comments
Not Done: NOT DONE Comments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784721
Page 10 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/4/2020
2.Randomization Number: [222215]
3.Randomization Group: [ ]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784722
Page 11 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/4/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM82V5]
5.bSample ID [BM82V6]
5.cSample ID [BM82V7]
5.dSample ID [BLCS71]
5.eSample ID [BLCS72]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784723
Page 12 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/4/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8FZ9]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784724
Page 13 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/4/2020 11:33
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784725
Page 14 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784726
Page 15 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784727
Page 16 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784728
Page 17 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
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
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784729
Page 18 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784730
Page 19 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784731
Page 20 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/27/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784732
Page 21 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8G60]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784733
Page 22 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/27/2020 09:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784734
Page 23 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784735
Page 24 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784736
Page 25 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
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
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784737
Page 26 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784738
Page 27 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/24/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8ZRR]
5.bSample ID [BNWZ9L]
5.cSample ID [BLCS1L]
5.dSample ID [BLCS1M]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784739
Page 28 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784740
Page 29 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [BRLTHW]
5.bSample ID [BSCK4W]
5.cSample ID [BSCKLM]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784741
Page 30 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784742
Page 31 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784743
Page 32 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784744
Page 33 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784745
Page 34 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784746
Page 35 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/2/2020
2.Date of First Symptom
Started:Oct/1/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/1/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
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? NO
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784747
Page 36 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784748
Page 37 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784749
Page 38 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings
/Details:Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784750
Page 39 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[no self swab obtained]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784751
Page 40 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/2/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPBX8L]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784752
Page 41 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784753
Page 42 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784754
Page 43 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
1.Not Done Not Done Not Do
ne Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784755
Page 44 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment
Identifier?Not Done
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784756
Page 45 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784757
Page 46 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1.Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784758
Page 47 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical
Event:Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784759
Page 48 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category f
or Lab TestVendor
NameCollecti
on Date:Specime
n TypeLab ResultForm Instan
ce
1.Not Done Not Do
ne Not Don
e Not Don
e Sponsor-Defi
ned IdentifierTest:Resul
t:
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Repeating
Pages
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784760
Page 49 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and
AddressNot Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784761
Page 50 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784762
Page 51 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784763
Page 52 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784764
Page 53 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784765
Page 54 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784766
Page 55 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784767
Page 56 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category f
or Lab Te
stVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
1.Not Done Not Done Not Do
ne Not Do
ne Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Repeating
Pages
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784768
Page 57 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category f
or Lab Te
stVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784769
Page 58 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and
AddressNot Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784770
Page 59 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784771
Page 60 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784772
Page 61 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784773
Page 62 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784774
Page 63 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784775
Page 64 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784776
Page 65 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784777
Page 66 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784778
Page 67 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784779
Page 68 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
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Page 69 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in
beats/minute:Not Done
[ ]Comments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784781
Page 70 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0784782
Page 71 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784783
Page 72 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1.Not Done Not Done Not Done Repeating
Pages
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784784
Page 73 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Done
[ ]Comments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784785
Page 74 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1.Not Done Not Done Not Done Not Done Not D
one Repeating
Pages
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784786
Page 75 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication
identifier?Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done 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 Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
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Page 76 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1.Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784788
Page 77 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784789
Page 78 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/30/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784790
Page 79 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/30/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/30/2020
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 [BR2MN8]
5.bSample ID [BSJK8K]
5.cSample ID [BS8BFD]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784791
Page 80 of 433
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784792
Page 81 of 433
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
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***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Sep/24/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784794
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***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784795
Page 84 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784796
Page 85 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784797
Page 86 of 433
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 worsening arthri
tis of right hip Oct/10/2020
UNK:UNK NO
End Date Time:
Dec/23/2020 UN
K:UNK
Repeating
Pages
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784798
Page 87 of 433
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[worsening arthritis of right hip]
4.Start Date Time: Oct/10/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/23/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
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Page 88 of 433
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[arthritis]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784800
Page 89 of 433
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant
Medication given?NO
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[2021187593]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784801
Page 90 of 433
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784802
Page 91 of 433
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784803
Page 92 of 433
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784804
Page 93 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784805
Page 94 of 433
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784806
Page 95 of 433
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784807
Page 96 of 433
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784808
Page 97 of 433
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784809
Page 98 of 433
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784810
Page 99 of 433
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784811
Page 100 of 433
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784812
Page 101 of 433
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784813
Page 102 of 433
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784814
Page 103 of 433
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784815
Page 104 of 433
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784816
Page 105 of 433
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784817
Page 106 of 433
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784818
Page 107 of 433
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784819
Page 108 of 433
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784820
Page 109 of 433
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784821
Page 110 of 433
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784822
Page 111 of 433
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784823
Page 112 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784824
Page 113 of 433
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784825
Page 114 of 433
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784826
Page 115 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/24/2020
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784827
Page 116 of 433
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784828
Page 117 of 433
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784829
Page 118 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-05-2020 14:28:29 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784830
Page 119 of 433
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-27-2020 14:22:17 (UTC-05:00)
Eastern Time (US & Canada)subject is post menopausal
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784831
Page 120 of 433
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aAug-07-2020 10:36:10 (UTC-05:00)
Eastern Time (US & Canada)Post-Menopausal
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784832
Page 121 of 433
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aAug-07-2020 10:36:10 (UTC-05:00)
Eastern Time (US & Canada)Post-Menopausal
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784833
Page 122 of 433
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aAug-07-2020 10:36:10 (UTC-05:00)
Eastern Time (US & Canada)Post-Menopausal
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784834
Page 123 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-02-2020 13:14:47 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784835
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-02-2020 13:14:47 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0784836
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-02-2020 13:14:47 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784837
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-02-2020 13:14:47 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784838
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-02-2020 13:14:47 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784839
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-02-2020 13:14:47 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0784840
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Oct-02-2020 13:14:47 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784841
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Oct-02-2020 13:14:47 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784842
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Oct-02-2020 13:14:47 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784843
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Oct-02-2020 13:14:47 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784844
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-02-2020 13:15:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784845
Page 134 of 433
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-02-2020 13:15:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784846
Page 135 of 433
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-02-2020 13:15:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784847
Page 136 of 433
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-02-2020 13:15:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784848
Page 137 of 433
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-02-2020 13:15:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784849
Page 138 of 433
***Confidential***
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Visit: POT_COVID_ILL 1 -
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-02-2020 13:15:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784850
Page 139 of 433
***Confidential***
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Oct-02-2020 13:15:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784851
Page 140 of 433
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-02-2020 13:16:21 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784852
Page 141 of 433
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Visit: POT_COVID_ILL 1 -
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-02-2020 13:16:21 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784853
Page 142 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: ILLNESS DETAILS - SEVERE - Comments
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-02-2020 13:16:21 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784854
Page 143 of 433
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Visit: POT_COVID_ILL 1 -
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-02-2020 13:16:21 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784855
Page 144 of 433
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Visit: POT_COVID_ILL 1 -
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-02-2020 13:16:21 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784856
Page 145 of 433
***Confidential***
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Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0784857
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Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0784858
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Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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FDA-CBER-2021-5683-0784859
Page 148 of 433
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0784860
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Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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FDA-CBER-2021-5683-0784861
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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FDA-CBER-2021-5683-0784864
Page 153 of 433
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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FDA-CBER-2021-5683-0784865
Page 154 of 433
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0784866
Page 155 of 433
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0784867
Page 156 of 433
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
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5.bOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
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ItemDate User Comment
5.cOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.cOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
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Back to Form
ItemDate User Comment
5.eOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0784881
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.fOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0784882
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-02-2020 13:16:36 (UTC-05:00)
Eastern Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0784889
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Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-02-2020 13:16:56 (UTC-05:00)
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Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
1Oct-02-2020 13:16:56 (UTC-05:00)
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ItemDate User Comment
2Oct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
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ItemDate User Comment
3Oct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
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4Oct-02-2020 13:16:56 (UTC-05:00)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
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Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.aOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
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Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.aOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
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Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.aOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.aOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
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Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.bOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.bOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
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(b) (4)
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Page 190 of 433
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784902
Page 191 of 433
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784903
Page 192 of 433
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784904
Page 193 of 433
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784905
Page 194 of 433
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784906
Page 195 of 433
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784907
Page 196 of 433
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784908
Page 197 of 433
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784909
Page 198 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784910
Page 199 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784911
Page 200 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784912
Page 201 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784913
Page 202 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784914
Page 203 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784915
Page 204 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784916
Page 205 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784917
Page 206 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784918
Page 207 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784919
Page 208 of 433
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784920
Page 209 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784921
Page 210 of 433
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784922
Page 211 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784923
Page 212 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784924
Page 213 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784925
Page 214 of 433
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784926
Page 215 of 433
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784927
Page 216 of 433
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784928
Page 217 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784929
Page 218 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784930
Page 219 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784931
Page 220 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784932
Page 221 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784933
Page 222 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-02-2020 13:16:56 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784934
Page 223 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-02-2020 13:17:18 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784935
Page 224 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-02-2020 13:17:18 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784936
Page 225 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aOct-02-2020 13:17:18 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784937
Page 226 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aOct-02-2020 13:17:18 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784938
Page 227 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aOct-02-2020 13:17:18 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784939
Page 228 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aOct-02-2020 13:17:18 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784940
Page 229 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-02-2020 13:17:29 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784941
Page 230 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-02-2020 13:17:29 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784942
Page 231 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aOct-02-2020 13:17:29 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784943
Page 232 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-02-2020 13:17:54 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784944
Page 233 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-02-2020 13:17:54 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784945
Page 234 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-02-2020 13:17:54 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784946
Page 235 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-02-2020 13:17:54 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784947
Page 236 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-02-2020 13:18:04 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784948
Page 237 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-02-2020 13:18:04 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784949
Page 238 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-02-2020 13:18:04 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784950
Page 239 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-02-2020 13:18:04 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784951
Page 240 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-02-2020 13:18:04 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784952
Page 241 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-02-2020 13:18:04 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784953
Page 242 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Oct-02-2020 13:18:04 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784954
Page 243 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-02-2020 13:18:14 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784955
Page 244 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-02-2020 13:18:14 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784956
Page 245 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-02-2020 13:18:14 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784957
Page 246 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-02-2020 13:18:14 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784958
Page 247 of 433
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/02/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-02-2020 13:18:14 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784959
Page 248 of 433
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-18-2021 17:38:14 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 21:57:35 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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-15-2021 08:52:00 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784960
Page 249 of 433
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
N/A
Approved Oct-30-2020 15:08:33 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Oct-30-2020 09:26:34 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-08-2020 16:03:07 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784961
Page 250 of 433
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, , 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 11:07:01 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Sep-10-2020 09:50:33 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784962
Page 251 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-04-2020
13:46:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-04-2020
13:46:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784963
Page 252 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-04-2020
13:46:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/4/2020Initial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784964
Page 253 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-04-2020
13:46:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10161042Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-04-2020
13:46:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1962Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-04-2020
13:47:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784965
Page 254 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020
13:47:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-04-2020
13:47:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784966
Page 255 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-04-2020
13:47:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020Initial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784967
Page 256 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-04-2020
13:47:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-04-2020
13:47:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-04-2020
13:47:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784968
Page 257 of 433
***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, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-04-2020
13:47:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Arthritis
Start Date: Sep/UN
K/2010
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-04-2020
13:47:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-04-2020
13:47:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ArthritisInitial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784969
Page 258 of 433
***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, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.a Start Date:
Date Location User Value Reason
Aug-04-2020
13:47:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-04-2020
13:47:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-04-2020
13:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:B12 Def
iciency
Start Date: Sep/UN
K/2018
Ongoing: YESInitial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784970
Page 259 of 433
***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, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-04-2020
13:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-04-2020
13:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
B12 DeficiencyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-04-2020
13:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-04-2020
13:48:18ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784971
Page 260 of 433
***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, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784972
Page 261 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-04-2020
13:48:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-04-2020
13:48:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
190.2Initial Entry
3. Unit:
Date Location User Value Reason
Aug-04-2020
13:48:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784973
Page 262 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020
13:48:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-04-2020
13:48:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-04-2020
13:48:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28.1Initial Entry
7.a
Date Location User Value Reason
Aug-04-2020
13:48:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.5Initial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784974
Page 263 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-04-2020
13:48:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-04-2020
13:48:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-04-2020
13:48:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784975
Page 264 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a Temperature Location:
Date Location User Value Reason
Aug-04-2020
13:48:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784976
Page 265 of 433
***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, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-04-2020
13:48:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-04-2020
13:48:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-26-2021
16:50:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Feb-24-2021
12:43:18
(UTC-05:00)ACV0PFEINFP6000 Query 2: Answe
redafter speaking
with cra she will
contact pfizer
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0784977
Page 266 of 433
***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, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time
(US & Canada)team to see if this
should be added
to medical
history or not.
Feb-23-2021
16:14:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissu
ed:OpenedCLINQUERY2-
Thank you for
your response.
MedHx page is
now unlocked for
edits.
Feb-19-2021
16:41:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answe
redplease unlock
and unfreeze and
this will be added
to the medical
history
Feb-19-2021
12:29:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opene
dCLINQUERY-
Per prior query
response at V1,
subject is
post-menopausal.
Please review
and ensure
MedHx is
updated.
Aug-11-2020
16:27:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Ahmed Hassan Query 1: Closed Response
satisfies query
Aug-11-2020
10:59:36ACV0PFEINFP6000 Query 1: Answe
redsubject
post-menopausal.
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0784978
Page 267 of 433
***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, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time
(US & Canada)added note.
should not be on
medical history
due to age
Aug-10-2020
16:20:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Ahmed Hassan Query 1: Reissu
ed:Openedplease can you
add this to the
medhx CRF as
appropriate.
thanks
Aug-10-2020
15:07:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answe
redsubject is post
menopausal-no
menses for 12
months
Aug-10-2020
11:36:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Ahmed Hassan Query 1: Opene
dPlease can you
confirm why a
pregnancy test
was not done for
this subject?
There is nothing
in her medical
history to
indicate she is
not a woman of
child bearing
potential. Thanks
Aug-04-2020
13:48:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020Initial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0784979
Page 268 of 433
***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, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-04-2020
13:48:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-10-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Closed Response
satisfies query
Aug-05-2020
09:22:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Opened Please can
you confirm
why a
pregnancy
test was not
done for this
subject?
There is
nothing in her
medical
history to
indicate she is
not a woman
of child
bearing
potential.
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0784980
Page 269 of 433
***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, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Thanks
Aug-04-2020
13:48:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-04-2020
13:48:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result::
Not Done
::NOT DON
EInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-04-2020
13:48:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784981
Page 270 of 433
***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, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a Test:
Date Location User Value Reason
Aug-04-2020
13:48:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-30-2020
19:11:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Aug-27-2020
14:22:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered comment
added/post
menoopausal
Aug-25-2020
22:09:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery:
CPG 2:Please
can you
confirm why a
pregnancy test
was not done?
there is nothing
in this womans'
medhx to
indicate she is
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784982
Page 271 of 433
***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, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
not a woman of
child bearing
potential.
Thanks
Aug-04-2020
13:48:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784983
Page 272 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-04-2020
13:49:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-04-2020
13:49:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
222215Initial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784984
Page 273 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-04-2020
13:49:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-04-2020
13:49:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-04-2020
13:49:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-04-2020
13:49:21
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784985
Page 274 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-04-2020
13:49:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/4/2020Initial Entry
5.a
Date Location User Value Reason
Aug-04-2020
13:49:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BM82V
5Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-04-2020
13:49:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BM82V5Initial Entry
5.b
Date Location User Value Reason
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784986
Page 275 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020
13:49:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BM82V
6Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-04-2020
13:49:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BM82V6Initial Entry
5.c
Date Location User Value Reason
Aug-04-2020
13:49:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BM82V
7Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-04-2020
13:49:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BM82V7Initial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784987
Page 276 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d
Date Location User Value Reason
Aug-04-2020
13:49:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BLCS7
1Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-04-2020
13:49:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLCS71Initial Entry
5.e
Date Location User Value Reason
Aug-04-2020
13:50:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BLCS7
2Initial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784988
Page 277 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.e Sample ID
Date Location User Value Reason
Aug-04-2020
13:50:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLCS72Initial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784989
Page 278 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-04-2020
13:50:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-04-2020
13:50:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-04-2020
13:50:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-04-2020
13:50:14
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0784990
Page 279 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-04-2020
13:50:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/4/2020Initial Entry
5.a
Date Location User Value Reason
Aug-04-2020
13:50:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BM8FZ
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-04-2020
13:50:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BM8FZ9Initial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784991
Page 280 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-04-2020
13:51:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-04-2020
13:51:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-04-2020
13:51:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784992
Page 281 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020
13:51:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020 11:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-04-2020
13:51:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-04-2020
13:51:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-04-2020
13:51:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784993
Page 282 of 433
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-04-2020
13:51:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-04-2020
13:51:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784994
Page 283 of 433
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-04-2020
13:51:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3fc9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0784995
Page 284 of 433
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020
14:25:27
(UTC-05:00)
Eastern Time (US
& Canad
…[truncated]