Document text
Page 1 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019711
Page 2 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/25/2020
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019712
Page 3 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10931058]
2.Birth Date: /1995
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:
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019713
Page 4 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019714
Page 5 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019715
Page 6 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019716
Page 7 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019717
Page 8 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
2.Weight: [136.2]
3.Unit: LB
4.Height: [63.5]
5.Unit: in
6.Body Mass Index: [23.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019718
Page 9 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/25/2020
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:
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019719
Page 10 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/25/2020
2.Randomization Number: [67013]
3.Randomization Group: [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019720
Page 11 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
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 [BP5D41]
5.bSample ID [BP5D42]
5.cSample ID [BP5D43]
5.dSample ID [BPR65W]
5.eSample ID [BPR65X]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019721
Page 12 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
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 [BPR65Y]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019722
Page 13 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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/25/2020 17:21
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019723
Page 14 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019724
Page 15 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019725
Page 16 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019726
Page 17 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/18/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: POSITIVE
Not Done:
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019727
Page 18 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
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 [BPR6R8]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019728
Page 19 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019729
Page 20 of 154
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019730
Page 21 of 154
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019731
Page 22 of 154
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019732
Page 23 of 154
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019733
Page 24 of 154
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019734
Page 25 of 154
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019735
Page 26 of 154
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019736
Page 27 of 154
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019737
Page 28 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019738
Page 29 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019739
Page 30 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019740
Page 31 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019741
Page 32 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019742
Page 33 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019743
Page 34 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019744
Page 35 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019745
Page 36 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019746
Page 37 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Unplanned Assessments
1.Assessments
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019747
Page 38 of 154
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/18/2020
2.Phase of Disposition: VACCINATION
3.Status: PREGNANCY
4.Specify Status: [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019748
Page 39 of 154
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Nov/9/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: LOST TO FOLLOW-UP
4.Specify Status: [Subject was lost to follow up.]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019749
Page 40 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019750
Page 41 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019751
Page 42 of 154
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 EXPOSURE DURING PRE
GNANCY Aug/25/2020 0
0:00 YES Repeating
Pages
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019752
Page 43 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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)[EXPOSURE DURING PREGNANCY]
4.Start Date Time: Aug/25/2020 00:00
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:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019753
Page 44 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019754
Page 45 of 154
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors A
ctionForm Instance
1. Repeating
Pages
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019755
Page 46 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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[ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019756
Page 47 of 154
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019757
Page 48 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: //
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019758
Page 49 of 154
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019759
Page 50 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019760
Page 51 of 154
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019761
Page 52 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019762
Page 53 of 154
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019763
Page 54 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019764
Page 55 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019765
Page 56 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019766
Page 57 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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:
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019767
Page 58 of 154
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019768
Page 59 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019769
Page 60 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019770
Page 61 of 154
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019771
Page 62 of 154
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019772
Page 63 of 154
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019773
Page 64 of 154
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019774
Page 65 of 154
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019775
Page 66 of 154
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019776
Page 67 of 154
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019777
Page 68 of 154
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019778
Page 69 of 154
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019779
Page 70 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/9/2020
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019780
Page 71 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019781
Page 72 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019782
Page 73 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormAug-26-2020 11:32:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019783
Page 74 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormAug-26-2020 11:32:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019784
Page 75 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormNov-02-2020 08:31:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019785
Page 76 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Nov-02-2020 08:31:16 (UTC-06:00) Central Time
(US & Canada)Not Done
1Sep-25-2020 12:54:56 (UTC-06:00) Central Time
(US & Canada)VACCINATION WAS NOT DONE; SUBJECT
HAS CONFIRMED PREGNANCY
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019786
Page 77 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Nov-02-2020 08:31:16 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019787
Page 78 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Nov-02-2020 08:31:16 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019788
Page 79 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Nov-02-2020 08:31:16 (UTC-06:00) Central Time
(US & Canada)Not Done
4Sep-25-2020 12:55:05 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019789
Page 80 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5Nov-02-2020 08:31:16 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019790
Page 81 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Nov-02-2020 08:31:16 (UTC-06:00) Central Time
(US & Canada)Not Done
6Sep-25-2020 12:55:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019791
Page 82 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
7Nov-02-2020 08:31:16 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019792
Page 83 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
8Nov-02-2020 08:31:16 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019793
Page 84 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
9Nov-02-2020 08:31:16 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019794
Page 85 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
10Nov-02-2020 08:31:16 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019795
Page 86 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
11Nov-02-2020 08:31:16 (UTC-06:00) Central Time
(US & Canada)Not Done
11Sep-25-2020 12:55:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019796
Page 87 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Nov-06-2020 08:28:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
6Nov-06-2020 08:28:14 (UTC-06:00) Central Time
(US & Canada)NOT APPLICABLE
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019797
Page 88 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 Nov-20-2020 11:35:25 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Ensz Approved Nov-17-2020 17:29:26 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidEnsz, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-16-2020 10:46:43 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Ensz Approved Nov-06-2020 22:47:44 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidEnsz, 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.
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019798
Page 89 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
N/A Nov-06-2020 08:28:14 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Ensz Approved Nov-03-2020 17:04:25 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidEnsz, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-03-2020 13:50:09 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Ensz Approved Nov-03-2020 10:41:24 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidEnsz, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-02-2020 08:31:07 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Ensz Approved Oct-26-2020 14:40:25 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019799
Page 90 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, DavidEnsz, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-26-2020 09:08:29 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Ensz Approved Oct-20-2020 08:57:52 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidEnsz, 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.
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019800
Page 91 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-26-2020 11:31:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-26-2020 11:31:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019801
Page 92 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-26-2020 11:31:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/25/2020Initial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019802
Page 93 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-26-2020 11:30:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10931058Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-26-2020 11:30:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1995Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-26-2020 11:31:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-26-2020 11:31:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-26-2020 11:31:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019803
Page 94 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-26-2020 11:31:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019804
Page 95 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-26-2020 11:32:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-26-2020 11:32:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-26-2020 11:32:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019805
Page 96 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Aug-26-2020 11:33:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-26-2020 11:33:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
136.2Initial Entry
3. Unit:
Date Location User Value Reason
Aug-26-2020 11:33:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-26-2020 11:35:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-26-2020 11:35:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
63.5Transcription Error
Aug-26-2020 11:33:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Height 36.5 is
outside of Normal
Range 140 - 198 for
cm or 55 - 80 for in.
Aug-26-2020 11:33:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.5Initial Entry
5. Unit:
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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-2021-5683-1019806
Page 97 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Aug-26-2020 11:33:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-26-2020 11:35:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.7Transcription Error
Aug-26-2020 11:33:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
71.9Initial Entry
7.a
Date Location User Value Reason
Aug-26-2020 11:35:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.7
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYTranscription Error
Aug-26-2020 11:33:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 38.7
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-26-2020 11:33:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019807
Page 98 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-26-2020 11:35:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-26-2020 11:35:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.7Transcription Error
Aug-26-2020 11:33:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 38.7 F
is outside of Normal
Range 97 - 99.5 F.
Aug-26-2020 11:33:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
38.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-26-2020 11:33:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-26-2020 11:33:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019808
Page 99 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-26-2020 11:33:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-26-2020 11:33:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-26-2020 11:33:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-26-2020 11:33:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-26-2020 11:33:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-26-2020 11:33:10
(UTC-06:00) Central TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define 113Initial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019809
Page 100 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada) d Identifier:
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-26-2020 11:33:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-26-2020 11:33:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-26-2020 11:33:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019810
Page 101 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-26-2020 11:33:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-26-2020 11:33:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
67013Initial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019811
Page 102 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020 11:33:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 11:33:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 08:40:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-26-2020 23:47:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-26-2020 11:33:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-26-2020 11:33:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
5.a
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1019812
Page 103 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Aug-27-2020 08:40:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5D41Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 08:40:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5D41Initial Entry
5.b
Date Location User Value Reason
Aug-27-2020 08:40:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5D42Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-27-2020 08:40:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5D42Initial Entry
5.c
Date Location User Value Reason
Aug-27-2020 08:41:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5D43Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-27-2020 08:41:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5D43Initial Entry
5.d
Date Location User Value Reason
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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-2021-5683-1019813
Page 104 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-08-2020 09:33:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR65WTranscription Error
Aug-27-2020 08:51:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR66FInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019814
Page 105 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.d Sample ID
Date Location User Value Reason
Sep-08-2020
15:00:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1
: ClosedAuto closed by
Validation Check:
VC_BEETRK001_06
Sep-08-2020
09:33:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1
: Answe
redTranscription Error
Sep-08-2020
09:33:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
BPR65
WTranscription Error
Sep-07-2020
00:19:59
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Open
edDM1: Page is now
unfrozen, kindly
make appropriate
update.
Sep-04-2020
17:42:02
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redPLEASE UNLOCK
SO THAT I MAY
CHANGED THE
BARCODE
Sep-04-2020
02:21:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1
: Opene
dDMW4607963;The
barcode BPR66F is
recorded for two
subjects 10931057
and 10931058. Please
review and update as
appropriate.
Aug-27-2020
08:51:17ACV0PFEINFP6000 Data E
ntry:Initial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1019815
Page 106 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-06:00)
Central Time
(US &
Canada)BPR66F
5.e
Date Location User Value Reason
Sep-08-2020 09:33:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR65XTranscription Error
Aug-27-2020 08:51:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR66GInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019816
Page 107 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.e Sample ID
Date Location User Value Reason
Sep-08-2020
15:00:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1
: ClosedAuto closed by
Validation Check:
VC_BEETRK001_06
Sep-08-2020
09:33:47
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1
: Answe
redTranscription Error
Sep-08-2020
09:33:47
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
BPR65
XTranscription Error
Sep-07-2020
00:20:13
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Open
edDM1: Page is now
unfrozen, kindly
make appropriate
update.
Sep-04-2020
17:42:23
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redPLEASE UNLOCK
SO I MAY CHANGE
THE BARCODE
Sep-04-2020
02:18:19
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1
: Opene
dDMW4607964;The
barcode BPR66G is
recorded for two
subjects 10931057
and 10931058. Please
review and update as
appropriate.
Aug-27-2020
08:51:25ACV0PFEINFP6000 Data E
ntry:Initial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1019817
Page 108 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-06:00)
Central Time
(US &
Canada)BPR66
G
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019818
Page 109 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020 11:33:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 11:33:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 08:58:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-26-2020 23:47:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-26-2020 11:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-26-2020 11:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
5.a
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019819
Page 110 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Aug-27-2020 08:58:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR65YInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 08:58:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR65YInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019820
Page 111 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-26-2020 11:34:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-26-2020 11:34:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-26-2020 11:34:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-26-2020 11:34:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020 17:21Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-26-2020 11:34:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-26-2020 11:34:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019821
Page 112 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7. Route:
Date Location User Value Reason
Aug-26-2020 11:34:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-26-2020 11:34:16
(UTC-06:00) Central 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-26-2020 11:34:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019822
Page 113 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-04-2020 00:32:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-03-2020 13:10:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Sep-03-2020 13:10:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLECT
ED FOR THIS SUBJECTTranscription Error
Sep-03-2020 10:26:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened eDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
'Yes' however VAX 1
eDiary records are not
available for the
subject. Please verify
and update. Else,
confirm in query
response
appropriately.
Aug-26-2020 11:35:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019823
Page 114 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-26-2020 15:04:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 3: Closed Response satisfies
query
Oct-26-2020 09:58:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered SUBJECT HAS
BEEN SCHEDULED
NUMEROUS TIMES
FOR A V3 AND
HAS NOT SHOWN
UP. GETTING
CLARIFICATION
ON IF SUBJECT IS
GOING TO BE
BROUGHT IN FOR
FURTHER SAFETY
FOLLOW UPS OR
NOT.
Oct-23-2020 17:12:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 3: Opened CLINQUERY: Please
clarify if subject has
continued in study for
safety follow up?
(treatment
discontinued). V3 not
completed
Sep-28-2020 23:48:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed As per site
confirmation -
updated PD tracker
Sep-28-2020 08:47:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Original value is
correct
Sep-28-2020 06:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened PDQ: DOV at this
visit is out of window
(1 day) from DOV
(25/Aug/2020) at
V1D1VX1L. Please
reconcile and update
accordingly, else
confirm date is
correct as is.
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1019824
Page 115 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-26-2020 13:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-25-2020 12:29:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Sep-25-2020 12:29:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
Sep-25-2020 05:16:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly review
and complete ‘Date of
Visit, Nasal Swab,
Vaccination, Vital
Signs' forms at this
visit. Thank you.
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019825
Page 116 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020 12:29:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
2.a
Date Location User Value Reason
Sep-25-2020 12:29:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.3
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-25-2020 12:29:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-25-2020 12:29:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-25-2020 12:29:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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-2021-5683-1019826
Page 117 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-25-2020 12:29:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019827
Page 118 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-25-2020 12:29:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-25-2020 12:29:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-25-2020 12:29:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-25-2020 12:29:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-25-2020 12:29:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-25-2020 12:29:46
(UTC-06:00) Central TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define 113Initial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019828
Page 119 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US & Canada) d Identifier:
Test:: Choriogonadotrop
in Beta_PX113
Result:: POSITIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-25-2020 12:29:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-25-2020 12:29:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-08-2020
08:58:09
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 3:
ClosedResolved on EOT
form
Nov-04-2020
05:00:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 3:
Reissue
d:Candi
dateIssue added in DM
Meeting and Q & A
sheet.
Nov-02-2020
16:21:40
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 3:
Answere
dDISPOSITION
eCRF WAS
STATUSED AS
PREGNANCY, WAS
QUERIED TO
CHANGE
DISPOSITION TO
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019829
Page 120 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
'ADVERSE
EVENT'.
Nov-01-2020
23:04:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 3:
OpenedDMW5235566;There
is a pregnancy test
with a positive result,
but there is no
disposition eCRF
with a 'Status' of
PREGNANCY with
a disposition date on
or after the
pregnancy test date.
Please review and
update as
appropriate.
Sep-29-2020
06:09:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
Closedclosed per SITE
response, added to
PD tracker
Sep-28-2020
08:48:09
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
Answere
dTHIS IS CORRECT,
HOWEVER,
SUBJECT WAS
NOT VAXED A
SECOND TIME
Sep-28-2020
02:25:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
OpenedPDQ: Result is
POSITIVE however,
Subject is
Randomized. Please
review and correct or
confirm.
Sep-27-2020
02:02:37
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedResponse satisfies
query
Sep-25-2020
12:30:40
(UTC-06:00)ACV0PFEINFP6000 Query 1:
Answere
dSUBJECT WAS
NOT VAXED
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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)
FDA-CBER-2021-5683-1019830
Page 121 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Central Time
(US &
Canada)
Sep-25-2020
12:29:46
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
OpenedLab result is
“Positive”, but
subject has been
vaccinated. Please
review and update as
appropriate. Else
explain.
Sep-25-2020
12:29:46
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
POSITI
VEInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019831
Page 122 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 08:28:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 08:28:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-21-2020 08:28:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-21-2020 08:28:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-21-2020 08:28:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-21-2020 08:28:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR6R8Initial Entry
5.a Sample ID
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019832
Page 123 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Sep-21-2020 08:28:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR6R8Initial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019833
Page 124 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-03-2020 06:48:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-02-2020 08:31:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Nov-02-2020 08:31:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-02-2020 08:31:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Nov-02-2020 05:03:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 1: Opened In case subject did
not receive
vaccination, please
remove the response
entered as NO and
apply form level
comment as NOT
DONE. Else clarify.
Sep-25-2020 12:54:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-02-2020 08:31:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-02-2020 08:31:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1019834
Page 125 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4. Dose Date Time:
Date Location User Value Reason
Sep-25-2020 12:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-02-2020 08:31:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-25-2020 12:55:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Nov-02-2020 08:31:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Nov-02-2020 08:31:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Nov-02-2020 08:31:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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-2021-5683-1019835
Page 126 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Nov-02-2020 08:31:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-25-2020 12:55:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019836
Page 127 of 154
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-28-2020 08:46:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-28-2020 08:46:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-30-2020 14:09:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 3: Closed Response satisfies
query
Nov-30-2020 13:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Transcription Error
Nov-30-2020 13:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PREGNANCYTranscription Error
Nov-30-2020 10:39:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 3: Opened CLINQUERY: Since
the AE involved was a
Pregnancy, please
capture PREGNANCY
as the status selection.
Apologies for prior
instruction to change
as appears in audit
trail.
Oct-29-2020 07:40:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine Puig Query 2: Closed query logic incorrect
Oct-29-2020 01:33:14 ACV0PFEINFP6000 Query 2: Reissued:Opened DM 1: Status is
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1019837
Page 128 of 154
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-06:00) Central
Time (US & Canada)recorded as
ADVERSE EVENT
on this form. However,
'Did the adverse event
cause the subject to be
discontinued from the
study' is not reported
as YES. Please review
and update. Else,
clarify.
Oct-27-2020 08:17:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered SUBJECT IS NOT
DISCONTINUED
FROM STUDY.
SUBJECT IS STILL
INCLUDED IN
STUDY FOR
FOLLOW UP
PROCEDURES.
WILL NOT BE
VACCINATED
AGAIN.
Oct-27-2020 03:28:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM: Per CRF CR
8.55.2, If Adverse
Event is primary
reason the Participant
was discontinued from
study then
corresponding AE
should have ‘Did the
adverse event cause
the Participant to be
discontinued from the
study?" as Yes. Please
review and update
CRF.
Oct-27-2020 03:19:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
updated.
Oct-26-2020 09:11:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered SUBJECT IS NOT
DISCONTINUED
FROM STUDY.
SUBJECT IS STILL
INCLUDED IN
STUDY FOR
FOLLOW UP
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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-2021-5683-1019838
Page 129 of 154
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
PROCEDURES.
WILL NOT BE
VACCINATED
AGAIN.
Oct-26-2020 09:08:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check and
correct the data.
Oct-26-2020 09:08:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-26-2020 09:08:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTTranscription Error
Oct-26-2020 06:15:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Per previous
response, 'HE AE IS
THE PRIMARY
REASON FOR THE
WITHDRAWAL'
kindly consider to
update status as
'ADVERSE EVENT'.
Oct-16-2020 07:24:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate Status needs to be
updated as AE.
Oct-14-2020 14:49:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered THE AE IS THE
PRIMARY REASON
FOR THE
WITHDRAWAL;
SUBJECT IS
PREGNANT.
Oct-14-2020 11:28:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: As per CRF CR
Section 8.55.2, If there
are two or more
reasons for withdrawal
and an adverse event is
one of them, the
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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-2021-5683-1019839
Page 130 of 154
***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, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
adverse event is
considered the primary
reason. Kindly update
data accordingly, else
clarify, Thank you.
Oct-12-2020 15:53:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered REASON FOR
DISCONTINUATION
IS PREGNANCY, AE
WAS MADE.
Oct-08-2020 08:56:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The Adverse
Event Action Taken is
DRUG
WITHDRAWN but
reason for treatment
discontinuation is not
reported as ADVERSE
EVENT or DEATH.
Please review and
clarify.
Sep-28-2020 08:46:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PREGNANCYInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019840
Page 131 of 154
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-05-2021 16:50:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-05-2021 16:50:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User ValueReason
Jan-31-2021
23:46:28
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedResponse satisfies query
Jan-29-2021
10:24:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
3: Clo
sedClose Auto Query
Jan-29-2021
10:23:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
3: Op
enedResponse to "Status" is
LOST TO FOLLOW-UP
but "Specify Status" is
missing.
Jan-29-2021
10:23:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: An
swere
dTranscription Error
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1019841
Page 132 of 154
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Jan-29-2021
10:23:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
LOST
TO F
OLL
OW-
UPTranscription Error
Jan-29-2021
01:04:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dAs per your response
'SUBJECT DID NOT
DISCONTINUE DUE
TO PREGNANCY.
SUBJECT WAS LOST
TO FOLLOW UP.'
please update the status
of this subject
accordingly on
DISPOSITION forms at
both EOT and FUP
visits.
Jan-28-2021
16:15:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dSUBJECT DID NOT
DISCONTINUE DUE
TO PREGNANCY.
SUBJECT WAS LOST
TO FOLLOW UP.
Jan-28-2021
12:55:46
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dResponse does not
satisfy query. If subject
discontinued due to the
pregnancy, the date on
this CRF should be
updated to be same as
EOT date.
Jan-27-2021
08:14:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dSUBJECT WAS LOST
TO FOLLOW UP
AFTER MULTIPLE
TIMES OF TRYING TO
CONTACT THEM.
Jan-26-2021
14:40:54
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dStatus is Pregnancy but
site replied that subject
is Lost to Follow-Up.
What is the reason of the
subject discontinuation?
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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-2021-5683-1019842
Page 133 of 154
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Canada) If it's the pregnancy, the
date should be updated
to be same as EOT. If it's
Lost to Follow-Up,
status should be updated
accordingly
Jan-25-2021
13:02:16
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dpositive pregnancy test
on 18sep2020. subject
was lost to follow up
09nov2020
Jan-25-2021
01:03:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Op
enedDMW6937447;Response
to 'Status' is
PREGNANCY, but there
is no pregnancy tests
with a positive result
with a 'Collection Date'
on or before the
disposition date. Please
review and update as
appropriate.
Jan-11-2021
19:22:47
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Jan-08-2021
13:04:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Jan-08-2021
13:04:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
PREG
NAN
CYTranscription Error
Jan-08-2021
12:07:27
(UTC-06:00)ACV0PFEINFP6000 Query
1: Op
enedClinical Subject
followup disposition is
Completed; however,
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1019843
Page 134 of 154
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Central Time
(US &
Canada)subj did not finish the 2
yr study. Per CRF
completion guidelines
Sect 8.56, instructions
for PG subjects (pg 204),
Pregnancy should be
entered
Jan-05-2021
16:50:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
COM
PLET
EDInitial Entry
4. Specify Status:
Date Location User Value Reason
Jan-29-2021 10:24:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Subject was lost to follow up.Initial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019844
Page 135 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Sep-25-2020 13:03:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019845
Page 136 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Sep-25-2020 13:03:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-25-2020 13:03:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-11-2021 19:23:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies query
Jan-05-2021 16:51:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered entry updated
Jan-04-2021 15:18:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened Clinical As per query
response, subject is lost to
followup. Please complete
the F/U disposition CRF
with final date of followup.
Jan-04-2021 15:09:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies query
Jan-04-2021 14:14:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered SUBJECT WAS LOST TO
FOLLOW UP. UNSURE
ON HOW TO PROCEED.
Dec-22-2020 12:14:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical - Please submit
SAE update with prior
pregnancy Hx with outcome
if ever PG, maternal
smoke/alcohol/illicit drug
use, and father information
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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-2021-5683-1019846
Page 137 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
including age and same use
profile
Dec-22-2020 10:15:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Candidate Clinical - Please submit
SAE update with prior
pregnancy Hx with outcome
if ever PG, maternal
smoke/alcohol/illicit drug
use, and father information
including age and same use
profile
Nov-17-2020
03:55:12 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Closed SAE term updated from
pregnancy to exposure
during pregnancy in SDB
Nov-16-2020
15:26:02 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Reissued:Candid
ateAwaiting safety update
Nov-16-2020
11:19:37 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Nov-16-2020
11:19:37 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
EXPOSURE DURING P
REGNANCYTranscription Error
Nov-16-2020
10:51:10 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Reissued:Opene
dSAE RECON 4: The term
in Safety database is still
reported as PREGNANCY,
a follow up AEM form is
needed to update term in
Safety database. Please
submit to match term in
both database
Nov-16-2020
10:46:43 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Nov-16-2020
10:46:43 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
MATERNAL EXPOSUR
E DURING PREGNANC
YTranscription Error
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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-2021-5683-1019847
Page 138 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-16-2020
09:58:00 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Reissued:Opene
dSAE RECON 3:Per
confirmation from PSSR,
last follow up form received
on 09NOV2020 does not
indicate update in term.
Please submit a follow up
AEM form to update term
to exposure during
pregnancy in Safety
database.
Nov-14-2020
09:33:52 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Reissued:Candid
atePending SDB update
Nov-13-2020
17:35:08 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Answered FOLLOW UP REPORT TO
UPDATE EVENT TERM
WAS SUBMITTED
Nov-13-2020
05:49:52 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Reissued:Opene
dSAE RECON 2:DSU
Confirmed; We have not
received a follow-up report
updating event term.Please
submit a follow up AEM
form to update term to
exposure during pregnancy
in Safety database.
Nov-12-2020
05:37:11 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Reissued:Candid
ateFor PSSR confirmation
Nov-11-2020
08:49:47 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Answered FORM HAS ALREADY
BEEN SUBMITTED.
Nov-11-2020
07:47:07 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Reissued:Opene
dSAE RECON 1:Per PSSR
confirmation AEM form
received however, the term
still reported as pregnancy.
Please submit a follow up
AEM form to update term
in Safety database.
Nov-07-2020
09:45:47 (UTC-06:00)ACV0PFEINFP6000 Query 2: Reissued:Candid
ateSAE RECON: To check
next SAE listing
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1019848
Page 139 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Central Time (US &
Canada)
Nov-06-2020
17:13:01 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Answered UPDATED SAE FORM
SUBMITTED WITH
UPDATED TERM OF
'EXPOSURE DURING
PREGNANCY'
Nov-04-2020
04:47:44 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Reissued:Opene
dPlease confirm if a follow
up AEM form was
submitted to update term in
SDB.
Nov-03-2020
13:50:49 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Nov-03-2020
13:50:49 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
EXPOSURE DURING P
REGNANCYTranscription Error
Nov-03-2020
07:45:42 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Opened SAE
RECON:AER#2020363457,
the term in both database
was recorded as pregnancy.
Based on the latest EDP
guidance,the term should be
reported as 'EXPOSURE
DURING PREGNANCY'.
Please confirm and
update.A follow up AEM
form is required to update
SDB.
Oct-12-2020 18:15:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed query closed; will follow
for SAE safety update with
BCP start month
Oct-12-2020 15:52:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered SAFETY REPORT WILL
BE SENT
Sep-28-2020 14:42:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY For oral
contraceptive with start in
'2020', please obtain start
date & month to clarify
which monthly cycle
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1019849
Page 140 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
subject was in when
contraception failed; submit
a safety report with the
updated start date
Sep-25-2020 13:03:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PREGNANCYInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-23-2020 03:38:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-20-2020 11:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020 00:00Transcription Error
Nov-20-2020 11:04:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered WILL UPDATE
START DATE TO
MATCH ONSET
DATE OF
25AUG2020
Nov-20-2020 05:16:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON:Per
case narrative'The
first day of LMP was
on 27Jul2020".Per
CRF CV v10_ section
8.50.2.5 Specific
Guidance for
Pregnancy, when the
participant was
pregnant before
enrollment,the onset
date = date of Vax1
(25 Aug 2020).Please
update accordingly
Oct-17-2020 07:54:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-16-2020 14:08:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered SENT ON
14OCT2020
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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-2021-5683-1019850
Page 141 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-12-2020 20:58:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON 1:
Onset date was
updated to
28Aug2020 in AE
CRF. Please confirm
if a follow up AEM
form was sent to
correct onset date in
SDB.
Oct-12-2020 15:51:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-12-2020 15:51:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 00:00Transcription Error
Oct-02-2020 08:16:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020363457
Sep-25-2020 13:03:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020 13:26Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-06-2021 22:59:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-06-2021 14:21:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered FUP PAGE HAS
ALREADY BEEN
DONE.
Jan-05-2021 23:22:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: If subject is
lost to follow up
then consider
updating FUP page
as appropriate.
Thank you.
Jan-05-2021 17:03:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered subject was lost to
follow up.
Jan-05-2021 16:50:51
(UTC-06:00) CentralACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019851
Page 142 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada) completed and this
Adverse Event is
still ongoing. Please
review and update
as appropriate.
Nov-03-2020 13:51:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019852
Page 143 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-03-2020 13:51:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-25-2020 13:03:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-06-2020 09:16:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Closed Response satisfies
query
Nov-06-2020 08:28:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-06-2020 08:28:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Nov-06-2020 08:28:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Nov-06-2020 08:02:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Opened CLINQUERY:
Toxicity grade for
EDP can be entered
as Not Applicable
(via comment
option). Please
update
Sep-29-2020 02:00:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-28-2020 08:46:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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) (4)
FDA-CBER-2021-5683-1019853
Page 144 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-28-2020 08:46:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
Sep-28-2020 08:12:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for "Toxicity Grade"
is missing. Kindly
review and update.
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
Oct-02-2020 09:39:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Deleted Close Auto Query
Sep-29-2020 13:35:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Sep-29-2020 08:45:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate For AE
PREGNANCY:
Response to "Is the
adverse event
serious?" is 'No' but
"Serious Adverse
Event Number" is
present.
Sep-29-2020 08:45:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Sep-29-2020 08:45:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription Error
Sep-28-2020 14:39:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINQUERY
According to CRF
completion
guidelines (Sect
8.49.2.5), pregnancy
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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-2021-5683-1019854
Page 145 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
is reported as an
Adverse event
(non-serious)
although an exposure
during pregnancy
form is sent to the
SAE vendor; please
update severity.
Sep-28-2020 05:38:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-28-2020 00:24:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened For AE
PREGNANCY:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Sep-25-2020 13:03:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
PREGNANCY:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Sep-25-2020 13:03:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
NOInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019855
Page 146 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-25-2020 13:03:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-25-2020 13:03:18
(UTC-06:00) Central
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
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-29-2020 05:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Closed Response satisfies
query
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1019856
Page 147 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-28-2020 08:46:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered TAB WILL BE
COMPLETED
Sep-28-2020 05:08:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Opened CLINQUERY:
Please complete
EOT tab to capture
end of treatment data
Sep-25-2020 13:03:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-25-2020 13:03:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-25-2020 13:03:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-16-2020 13:50:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Nov-16-2020 13:50:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 5: Closed Response satisfies
query
Nov-16-2020 11:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 5: Answered AE is ongoing
Nov-16-2020 11:19:37
(UTC-06:00) CentralACV0PFEINFP6000 auto query
(autoquery)Query 5: Opened For AE EXPOSURE
DURING
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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)
(b) (4)
FDA-CBER-2021-5683-1019857
Page 148 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada) PREGNANCY:
Response to "What
was the outcome of
this adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse
event still ongoing?"
is marked "Yes".
Nov-16-2020 10:48:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered AE IS STILL
ONGOING.
Nov-16-2020 10:46:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Opened For AE MATERNAL
EXPOSURE
DURING
PREGNANCY:
Response to "What
was the outcome of
this adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse
event still ongoing?"
is marked "Yes".
Nov-05-2020 02:17:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Nov-04-2020 07:57:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered PER QUERY, I WAS
TOLD TO CHANGE
OUT OF ADVERSE
EVENT TO
'UNKNOWN'. AE IS
STILL ONGOING.
Nov-04-2020 04:46:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-04-2020 02:22:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Reissued:Opened For AE EXPOSURE
DURING
PREGNANCY:
Response to "What
was the outcome of
this adverse event?" is
'Unknown' but "Is the
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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-2021-5683-1019858
Page 149 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
adverse event still
ongoing?" is marked
"Yes". Please update
or clarify.
Nov-03-2020 13:52:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered THERE IS NO END
DATE PROVIDED
Nov-03-2020 13:51:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened For AE EXPOSURE
DURING
PREGNANCY:
Response to "What
was the outcome of
this adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse
event still ongoing?"
is marked "Yes".
Nov-03-2020 13:51:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-03-2020 13:50:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE EXPOSURE
DURING
PREGNANCY:
Response to "What
was the outcome of
this adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse
event still ongoing?"
is marked "Yes".
Nov-03-2020 13:50:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE
PREGNANCY:
Response to "What
was the outcome of
this adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse
event still ongoing?"
is marked "Yes".
Nov-03-2020 13:50:09 ACV0PFEINFP6000 auto query Query 1: Answered Transcription Error
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1019859
Page 150 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-06:00) Central
Time (US & Canada)(autoquery)
Nov-03-2020 13:50:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNTranscription Error
Nov-03-2020 07:47:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020363457,
the outcome in AE
CRF was reported as
NOT
RECOVERED/NOT
RESOLVED.Based on
the latest EDP
guidance, outcome
should be recorded as
UNKNOWN. Please
confirm and update
accordingly.
Sep-25-2020 13:03:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-25-2020 13:03:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-02-2020 09:39:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Event is a
nonserious event.
AER remains valid
in Safety database
per case processing
convention.
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (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-2021-5683-1019860
Page 151 of 154
***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, Not Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-28-2020 05:38:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020363457Initial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019861
Page 152 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject Status
Date Location User Value Reason
Jan-29-2021 10:23:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Jan-08-2021 13:04:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Jan-05-2021 16:50:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COMPLETEDInitial Entry
Nov-30-2020 13:55:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Oct-26-2020 09:08:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Sep-28-2020 08:46:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Aug-26-2020 11:33:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-26-2020 11:32:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-29-2021 10:23:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/9/2020Transcription Error
Jan-08-2021 13:04:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/9/2020Transcription Error
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019862
Page 153 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Jan-05-2021 16:50:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/9/2020Initial Entry
Nov-30-2020 13:55:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/18/2020Transcription Error
Oct-26-2020 09:08:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/18/2020Transcription Error
Sep-28-2020 08:46:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/18/2020Initial Entry
Aug-26-2020 11:33:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
Aug-26-2020 11:32:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019863
Page 154 of 154
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-15-2020 15:22:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f51\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019864