Document text
Page 1 of 189
***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: 10161103 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
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785394
Page 2 of 189
***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: 10161103 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/12/2020
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785395
Page 3 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10161103]
2.Birth Date: /1991
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:
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785396
Page 4 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/12/2020
2.Erroneous Visit
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785397
Page 5 of 189
***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: 10161103 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
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785398
Page 6 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785399
Page 7 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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:[Attention Deficit Hyperactivity Disorder]
Start Date: Nov/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Factor 5 Leiden Mutation]
Start Date: Feb/UNK/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: May/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: Jun/UNK/2020
Ongoing: YES
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785400
Page 8 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Restless Leg syndrome]
Start Date: Nov/UNK/2015
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Migraines]
Start Date: Jan/UNK/2020
Ongoing: YES
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785401
Page 9 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/12/2020
2.Weight: [244.0]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [41.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785402
Page 10 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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/12/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785403
Page 11 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/12/2020
2.Randomization Number: [46237]
3.Randomization Group: [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785404
Page 12 of 189
***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: 10161103 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/12/2020
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 [BM8315]
5.bSample ID [BM8316]
5.cSample ID [BM8317]
5.dSample ID [BLCSBZ]
5.eSample ID [BLCSC0]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785405
Page 13 of 189
***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: 10161103 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/12/2020
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 [BM8G1B]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785406
Page 14 of 189
***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: 10161103 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/12/2020 12:12
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785407
Page 15 of 189
***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: 10161103 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
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785408
Page 16 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785409
Page 17 of 189
***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: 10161103 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
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
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785410
Page 18 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
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
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785411
Page 19 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785412
Page 20 of 189
***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: 10161103 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: Sep/2/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785413
Page 21 of 189
***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: 10161103 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:
Sep/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPBX08]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785414
Page 22 of 189
***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: 10161103 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: Sep/2/2020 14:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785415
Page 23 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785416
Page 24 of 189
***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: 10161103 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
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
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785417
Page 25 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
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
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785418
Page 26 of 189
***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: 10161103 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/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 [BP8ZTB]
5.bSample ID [BNWZC6]
5.cSample ID [BLCS3F]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785419
Page 27 of 189
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785420
Page 28 of 189
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785421
Page 29 of 189
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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 [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785422
Page 30 of 189
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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 [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785423
Page 31 of 189
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785424
Page 32 of 189
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785425
Page 33 of 189
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785426
Page 34 of 189
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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 [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785427
Page 35 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785428
Page 36 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785429
Page 37 of 189
***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: 10161103 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/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785430
Page 38 of 189
***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: 10161103 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: [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785431
Page 39 of 189
***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: 10161103 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:
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785432
Page 40 of 189
***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: 10161103 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 [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785433
Page 41 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 cellulitis of face Jan/31/2021 UNK:
UNK NO
End Date Time:
Feb/10/2021 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 exposure during pre
gnancy Feb/23/2021 UNK
:UNK YES Repeating
Pages
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785434
Page 42 of 189
***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: 10161103 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)[cellulitis of face]
4.Start Date Time: Jan/31/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/10/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[bacterial skin infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785435
Page 43 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785436
Page 44 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[exposure during pregnancy]
4.Start Date Time: Feb/23/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[pregnancy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785437
Page 45 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785438
Page 46 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785439
Page 47 of 189
***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: 10161103 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[ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785440
Page 48 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785441
Page 49 of 189
***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: 10161103 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: //
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785442
Page 50 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785443
Page 51 of 189
***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: 10161103 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?
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785444
Page 52 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785445
Page 53 of 189
***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: 10161103 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?
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785446
Page 54 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785447
Page 55 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785448
Page 56 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785449
Page 57 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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:
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785450
Page 58 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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:
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785451
Page 59 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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?
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785452
Page 60 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785453
Page 61 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785454
Page 62 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785455
Page 63 of 189
***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: 10161103 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 per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785456
Page 64 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/23/2020
2.Erroneous Visit
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785457
Page 65 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/23/2020
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785458
Page 66 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785459
Page 67 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Dec/23/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785460
Page 68 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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: Dec/23/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785461
Page 69 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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:
Dec/23/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR7L9M]
5.bSample ID [BSJKFT]
5.cSample ID [BSCKCC]
5.dSample ID [BSCKCD]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785462
Page 70 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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:
Dec/23/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR2N1T]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785463
Page 71 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Dec/23/2020 10:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785464
Page 72 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/16/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785465
Page 73 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785466
Page 74 of 189
***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: 10161103 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: [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785467
Page 75 of 189
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785468
Page 76 of 189
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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: Jan/13/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785469
Page 77 of 189
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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:
Jan/13/2021
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 [BR2N4K]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785470
Page 78 of 189
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/13/2021 09:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785471
Page 79 of 189
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785472
Page 80 of 189
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/10/2021
3.Comments: [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785473
Page 81 of 189
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785474
Page 82 of 189
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785475
Page 83 of 189
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785476
Page 84 of 189
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785477
Page 85 of 189
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/10/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785478
Page 86 of 189
***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: 10161103 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/30/2020
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785479
Page 87 of 189
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 10161103 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
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785480
Page 88 of 189
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 10161103 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
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785481
Page 89 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-13-2020 08:21:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785482
Page 90 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Mar-04-2021 12:47:09 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785483
Page 91 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormDec-23-2020 14:09:44 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785484
Page 92 of 189
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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-10-2021 10:19:13 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 22:23:31 (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 Dec-17-2020 10:18:30 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-08-2020 16:25:46 (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.
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785485
Page 93 of 189
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
N/A Sep-18-2020 16:14:43 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Sep-10-2020 17:19:22 (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.
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785486
Page 94 of 189
***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: 10161103 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-13-2020 08:20:29
(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-13-2020 08:20:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785487
Page 95 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-13-2020 08:20:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/12/2020Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785488
Page 96 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-13-2020 08:20:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10161103Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-13-2020 08:20:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1991Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-13-2020 08:20:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-13-2020 08:20:49
(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-13-2020 08:20:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785489
Page 97 of 189
***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: 10161103 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-13-2020 08:20:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785490
Page 98 of 189
***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: 10161103 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-13-2020 08:21:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-13-2020 08:21:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-13-2020 08:21:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785491
Page 99 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-13-2020 08:22:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Attention Deficit Hy
peractivity Disorder
Start Date: Nov/UNK/2015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:22:34
(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-13-2020 08:22:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Attention Deficit Hyperactivity Di
sorderInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-13-2020 08:22:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-13-2020 08:22:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785492
Page 100 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-20-2020 13:47:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:2
Medical Histo
ry Term:Factor 5 Leiden
Mutation
Start Date: Feb/UNK/2019
Ongoing: YESTranscription Error
Aug-13-2020 08:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Factor IV
Start Date: Feb/UNK/2
019
Ongoing: YESInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785493
Page 101 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:23:15
(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 ValueReason
Aug-21-2020
19:06:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
1: Clo
sedDiscrepancy has
been closed.
Aug-21-2020
04:14:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedResponse satisfies
query
Aug-20-2020
13:47:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query
1: An
swere
dTranscription Error
Aug-20-2020
13:47:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Factor
5 Leid
en Mu
tationTranscription Error
Aug-20-2020
09:52:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dCoding cannot take
place with the term
as stated. Please
update the term to
clarify Factor IV.
Are you reporting
COAGULATION
FACTOR IV
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0785494
Page 102 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
LEVEL TEST?
PLATELET
FACTOR 4
LEVEL TEST? If
so, update the
verbatim term as
such. Otherwise
clarify and edit the
term.
Aug-19-2020
08:08:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dThis subject meets
all criteria to enroll
in study
Aug-18-2020
23:41:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dClinQuery: Factor
IV: Please can you
confirm if subject
meets exclusion
criterion #10?
Aug-17-2020
13:27:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dsubject does not.
Aug-17-2020
12:52:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dCoding cannot take
place with the term
as stated. Please
update the term to
clarify Factor IV.
Aug-17-2020
08:04:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dplease confirm
subject meets
inclusion/exclusion
criteria
Aug-16-2020
03:11:17
(UTC-05:00)ACV0PFEINFP6000 Query
2: Op
enedFactor IV: Please
can you confirm if
subject meets
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785495
Page 103 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time
(US &
Canada)exclusion criterion
#10?
Aug-14-2020
15:01:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dOriginal value is
correct
Aug-14-2020
12:43:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dPlease update the
term to better
clarify FACTOR
IV
Aug-14-2020
07:33:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dsubject has a
diagnosis of factor
5
Aug-13-2020
11:02:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
1: Op
enedClarify FACTOR
IV as follows...The
term appears
incomplete. Are
you reporting
COAGULATION
FACTOR IV
LEVEL TEST?
PLATELET
FACTOR 4
LEVEL TEST? If
so, update the
verbatim term as
such. Otherwise
clarify and edit the
term. Thank you.
Aug-13-2020
08:23:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Factor
IVInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0785496
Page 104 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Start Date:
Date Location User Value Reason
Aug-13-2020 08:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-13-2020 08:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-13-2020 08:23:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:Obesity
Start Date: May/UNK/2
019
Ongoing: YESInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785497
Page 105 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:23:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 08:23:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ObesityInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-13-2020 08:23:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
May/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-13-2020 08:23:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-13-2020 08:24:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:Anxiety
Start Date: Jun/UNK/20
20
Ongoing: YESInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785498
Page 106 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:24:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 08:24:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AnxietyInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-13-2020 08:24:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-13-2020 08:24:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-20-2020 13:47:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:Restless Leg sy
ndrome
Start Date: Nov/UNK/201
5
Ongoing: YESTranscription Error
Aug-13-2020 08:24:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785499
Page 107 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History T
erm:Restless Leg
Start Date: Nov/UNK/2
015
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:24:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 13:47:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Restless Leg syndromeTranscription Error
Aug-13-2020 08:24:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Restless LegInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-13-2020 08:24:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/UNK/2015Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-13-2020 08:24:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-13-2020 08:24:49
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785500
Page 108 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Medical History Te
rm:Migraines
Start Date: Jan/UNK/20
20
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:24:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 08:24:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MigrainesInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-13-2020 08:24:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-13-2020 08:24:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0785501
Page 109 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-13-2020 08:25:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-13-2020 08:25:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
244.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-13-2020 08:25:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-13-2020 08:25:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-13-2020 08:25:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-13-2020 08:25:15
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
41.9Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785502
Page 110 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-13-2020 08:25:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.2
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-13-2020 08:25:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-13-2020 08:25:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-13-2020 08:25:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-13-2020 08:25:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785503
Page 111 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-13-2020 08:25:25
(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-13-2020 08:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-13-2020 08:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-13-2020 08:25:25
(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-13-2020 08:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-13-2020 08:25:25 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785504
Page 112 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-13-2020 08:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-13-2020 08:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-13-2020 08:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785505
Page 113 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-13-2020 08:25:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-13-2020 08:25:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
46237Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785506
Page 114 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020 08:25:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020 08:25:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020 08:25:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-13-2020 08:25:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-13-2020 08:25:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020 08:25:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM8315Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785507
Page 115 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-13-2020 08:25:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM8315Initial Entry
5.b
Date Location User Value Reason
Aug-13-2020 08:26:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM8316Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-13-2020 08:26:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM8316Initial Entry
5.c
Date Location User Value Reason
Aug-13-2020 08:26:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM8317Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-13-2020 08:26:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM8317Initial Entry
5.d
Date Location User Value Reason
Aug-13-2020 08:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLCSBZInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785508
Page 116 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Aug-13-2020 08:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLCSBZInitial Entry
5.e
Date Location User Value Reason
Aug-13-2020 08:26:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLCSC0Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-13-2020 08:26:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLCSC0Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785509
Page 117 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020 08:26:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020 08:26:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020 16:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Erica Weaver Query 2: Closed Response satisfies
query
Sep-18-2020 16:14:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Sep-18-2020 16:14:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/12/2020Transcription Error
Sep-18-2020 14:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Erica Weaver Query 2: Reissued:Opened Please enter
explanation in item
4 why sample was
not taken on same
day as vaccination.
Sep-18-2020 08:17:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered please see sample
shows collected and
barcode is entered
for this subject for
visit
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0785510
Page 118 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020 01:23:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Nasal Swab sample
is collected after
Vaccination 1,
however response
to “If no sample
was collected or
sample was not
collected according
to protocol, please
provide reason:" is
missing. Please
update.
Aug-13-2020 08:26:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-13-2020 08:26:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-13-2020 08:26:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/13/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020 08:26:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM8G1BInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020 08:26:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM8G1BInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785511
Page 119 of 189
***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: 10161103 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-13-2020 08:28:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-13-2020 08:28:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-13-2020 08:28:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-13-2020 08:28:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020 12:12Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-13-2020 08:28:22
(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-13-2020 08:28:22
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785512
Page 120 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-13-2020 08:28:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-13-2020 08:28:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-13-2020 08:28:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785513
Page 121 of 189
***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: 10161103 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-13-2020 08:28:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785514
Page 122 of 189
***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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020 16:45:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785515
Page 123 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785516
Page 124 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
GU
E
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785517
Page 125 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.c Symptom:
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785518
Page 126 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785519
Page 127 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Symptom:
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785520
Page 128 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785521
Page 129 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785522
Page 130 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 16:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785523
Page 131 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020 16:45:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2.a
Date Location User Value Reason
Sep-02-2020 16:45:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.4
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-02-2020 16:45:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-02-2020 16:45:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-02-2020 16:45:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785524
Page 132 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-02-2020 16:45:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785525
Page 133 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-02-2020 16:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-02-2020 16:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-02-2020 16:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-02-2020 16:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-02-2020 16:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-02-2020 16:46:05 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785526
Page 134 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-02-2020 16:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-02-2020 16:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-02-2020 16:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785527
Page 135 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 16:56:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 16:56:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 16:56:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 16:56:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-02-2020 16:56:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020 16:56:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPBX08Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785528
Page 136 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 16:56:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPBX08Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785529
Page 137 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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
Sep-02-2020 16:48:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020 16:48:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020 16:48:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-02-2020 16:48:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020 14:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020 16:48:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-02-2020 16:48:01
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0785530
Page 138 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-02-2020 16:48:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-02-2020 16:48:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-02-2020 16:48:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785531
Page 139 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020 16:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785532
Page 140 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785533
Page 141 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
GU
E
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785534
Page 142 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.c Symptom:
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0785535
Page 143 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785536
Page 144 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Symptom:
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785537
Page 145 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785538
Page 146 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785539
Page 147 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785540
Page 148 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020 16:26:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020 16:26:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-30-2020 16:26:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-30-2020 16:26:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-30-2020 16:26:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Sep-30-2020 16:26:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8ZTBInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785541
Page 149 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-30-2020 16:26:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8ZTBInitial Entry
5.b
Date Location User Value Reason
Sep-30-2020 16:27:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWZC6Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-30-2020 16:27:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWZC6Initial Entry
5.c
Date Location User Value Reason
Sep-30-2020 16:27:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLCS3FInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-30-2020 16:27:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLCS3FInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785542
Page 150 of 189
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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
Sep-30-2020 16:27:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-30-2020 16:27:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-30-2020 16:27:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785543
Page 151 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Feb-10-2021 12:19:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785544
Page 152 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-04-2021 12:46:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785545
Page 153 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-10-2021 12:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-10-2021 12:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-12-2021 18:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-12-2021 15:10:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered subject not
hospitalized for this
ae
Feb-12-2021 12:27:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened clinical: pls confirm
subject not
hospitalized for AE.
Thanks
Feb-10-2021 12:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cellulitis of faceInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-10-2021 12:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/31/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785546
Page 154 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Feb-10-2021 12:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/10/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-10-2021 12:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-10-2021 12:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-10-2021 12:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-10-2021 12:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785547
Page 155 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
OTHER
If Other, specify:
bacterial skin infection
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-10-2021 12:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-10-2021 12:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-10-2021 12:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-10-2021 12:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-10-2021 12:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785548
Page 156 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-04-2021 12:46:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-04-2021 12:46:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-12-2021 18:38:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered this will be updated
Mar-12-2021 16:35:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical Followup -
Event term is EDP;
however, PG Safety
event term is still
PREGNANCY.
Please submit a PG
safety update with
the EDP term, per
PG reporting
instructions
Mar-09-2021 10:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Query closed; will
follow for requested
updated SAE event
term of EDP.
Mar-08-2021 17:23:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Query closed; will
follow for requested
Con Meds
information.
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785549
Page 157 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-08-2021 11:45:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered site does not have
that information at
this time
Mar-08-2021 11:44:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered this will be updated
Mar-08-2021 09:05:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical - please
submit a PG safety
update with the
subject's CON
MEDS
Mar-08-2021 09:05:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - Event term
is EDP; however,
PG Safety event
term is
PREGNANCY.
Please submit a PG
safety update with
the EDP term, per
PG reporting
instructions
Mar-04-2021 12:46:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
exposure during pregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-12-2021 18:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered this was recorded on
pg form when first
submitted that
subject had visit to
replace device
Mar-12-2021 16:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Clinical - thank you;
please submit the PG
Safety update ASAP
to clarify routine
GYN appt /IUD in
place / PG start date
is that visit date.
Clearly the
conception date is
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785550
Page 158 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
earlier; please report
date based on OB
Ultrasound when
available
Mar-12-2021 14:55:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered the patient reported
she was found to be
pregnant on
23Feb2021 during a
routine GYN
appointment.. no
further information
is known at this
time..she did not
know date of last
menstrual cycle as pt
had IUD in place.
Mar-11-2021 21:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical - Please
specify how PG start
date was determined;
if not the 1st day of
LMP, is it an
estimated conception
date (by OB
ultrasound, or other
means)
Mar-11-2021 21:37:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Query closed; will
follow for requested
IUD information.
Mar-10-2021 07:13:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered this was not removed
before conception.
the subject was
getting replaced
when subject found
out pregnant. this
will be added to the
updated form if not
already written on
the sae report of the
pregnancy report
Mar-09-2021 22:26:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Clinical thank you;
please submit IUD
usage information
(was it removed
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0785551
Page 159 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
before conception; if
so, when)
Mar-09-2021 12:04:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered per visit 1 source
document last
menstrual period was
8/6/12 due
intrauterine device.
site will follow-up
with subject if
information is still
correct
Mar-09-2021 10:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Clinical - understand
this is PG start date;
please specify which
of the 2 methods
allowed in study for
this date it is: 1st day
LMP, or estimated
conception date
Mar-08-2021 11:45:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered this is the date that
subject became
pregnant
Mar-08-2021 09:06:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - the Start
date is 23Feb21;
however, there is no
documentation for
this start date. Please
submit a PG safety
update with LMP
date, and estimated
date of conception if
available; Start date
should be one of
these 2
Mar-04-2021 12:46:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/23/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021 12:46:42 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0785552
Page 160 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern
Time (US & Canada)YES
6. Toxicity Grade:
Date Location User Value Reason
Mar-04-2021 12:47:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-04-2021 12:46:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-04-2021 12:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-04-2021 12:46:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
pregnancyInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785553
Page 161 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-04-2021 12:46:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-04-2021 12:46:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-04-2021 12:46:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-04-2021 12:46:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-04-2021 12:46:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785554
Page 162 of 189
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-17-2020 10:18:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/16/2020Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785555
Page 163 of 189
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-17-2020 10:18:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national reco
mmendations and confirmed to
have received only placebo at
Vaccination 1/2Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785556
Page 164 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-23-2020 14:09:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785557
Page 165 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-23-2020 14:09:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/23/2020Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785558
Page 166 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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
Dec-23-2020 14:09:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-23-2020 14:09:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-23-2020 14:09:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785559
Page 167 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-23-2020 14:10:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-23-2020 14:10:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-23-2020 14:10:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-23-2020 14:10:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-23-2020 14:10:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Dec-23-2020 14:10:04 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785560
Page 168 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Dec-23-2020 14:10:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-23-2020 14:10:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Dec-23-2020 14:10:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785561
Page 169 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-23-2020 14:10:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-23-2020 14:10:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-23-2020 14:10:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-23-2020 14:10:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-23-2020 14:10:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/23/2020Initial Entry
5.a
Date Location User Value Reason
Dec-23-2020 14:10:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR7L9MInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785562
Page 170 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Dec-23-2020 14:10:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR7L9MInitial Entry
5.b
Date Location User Value Reason
Dec-23-2020 14:10:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSJKFTInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-23-2020 14:10:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSJKFTInitial Entry
5.c
Date Location User Value Reason
Dec-23-2020 14:11:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSCKCCInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-23-2020 14:11:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSCKCCInitial Entry
5.d
Date Location User Value Reason
Dec-23-2020 14:11:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSCKCDInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785563
Page 171 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Dec-23-2020 14:11:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSCKCDInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785564
Page 172 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-23-2020 14:11:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-23-2020 14:11:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-23-2020 14:11:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-23-2020 14:11:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/23/2020Initial Entry
5.a
Date Location User Value Reason
Dec-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR2N1TInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785565
Page 173 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Dec-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR2N1TInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785566
Page 174 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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
Dec-23-2020 14:12:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-23-2020 14:12:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-23-2020 14:12:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-23-2020 14:12:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020 10:44Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-23-2020 14:12:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-23-2020 14:12:11
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785567
Page 175 of 189
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Dec-23-2020 14:12:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-23-2020 14:12:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-23-2020 14:12:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-23-2020 14:12:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-23-2020 14:12:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785568
Page 176 of 189
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-17-2020 10:18:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/16/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-17-2020 10:18:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785569
Page 177 of 189
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-13-2021 11:49:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/13/2021Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785570
Page 178 of 189
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-13-2021 11:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-13-2021 11:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-13-2021 11:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/13/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-13-2021 11:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-13-2021 11:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jan-13-2021 11:49:30 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785571
Page 179 of 189
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Jan-13-2021 11:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-13-2021 11:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Jan-13-2021 11:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785572
Page 180 of 189
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-13-2021 11:49:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-13-2021 11:49:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-13-2021 11:49:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-13-2021 11:49:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-13-2021 11:49:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/13/2021Initial Entry
5.a
Date Location User Value Reason
Jan-13-2021 11:49:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR2N4KInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785573
Page 181 of 189
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Jan-13-2021 11:49:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR2N4KInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785574
Page 182 of 189
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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
Jan-13-2021 11:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-13-2021 11:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-13-2021 11:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-13-2021 11:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/13/2021 09:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-13-2021 11:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-13-2021 11:50:22
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785575
Page 183 of 189
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-13-2021 11:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-13-2021 11:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-13-2021 11:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-13-2021 11:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-13-2021 11:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785576
Page 184 of 189
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-10-2021 10:19:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/10/2021Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785577
Page 185 of 189
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
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: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-10-2021 10:19:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-10-2021 10:19:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Feb/10/2021Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785578
Page 186 of 189
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 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
Feb-11-2021
07:14:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedIncorrect Query
Feb-10-2021
17:00:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW7223752;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Feb-10-2021
10:21:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry:
Feb/10
/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-10-2021 10:21:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Feb-10-2021 10:21:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0785579
Page 187 of 189
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Sep-30-2020 16:27:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-13-2020 08:25:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-13-2020 08:21:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-04-2021 13:56:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Entered on the AE log CRF
Mar-04-2021 10:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered will be entered after PI
assessment
Mar-04-2021 05:21:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2021236152
pregnancy(onset
date:23Feb2021)was
reported in Safety database
but missing in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Sep-30-2020 16:27:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/30/2020Initial Entry
Aug-13-2020 08:25:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/12/2020Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785580
Page 188 of 189
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-13-2020 08:21:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/12/2020Initial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785581
Page 189 of 189
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161103 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-10-2020 08:08:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fcd\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785582