125742 S1 M5 CRF c4591001 1120 11201127

Document text

Page 1 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798856
Page 2 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/11/2020
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798857
Page 3 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11201127]
2.Birth Date: 1945
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798858
Page 4 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798859
Page 5 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798860
Page 6 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798861
Page 7 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to Allbuterol]
Start Date: UNK/UNK/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic obstructive pulmonary disease]
Start Date: UNK/UNK/1990
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal reflux disease]
Start Date: UNK/UNK/1990
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hyperlipidemia]
Start Date: UNK/UNK/2005
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post Traumatic stress disorder]
Start Date: Jan/UNK/2020
Ongoing: YES
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798862
Page 8 of 132
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Aug/11/2020
2.Weight: [130.4]
3.Unit: kg
4.Height: [189.0]
5.Unit: cm
6.Body Mass Index: [36.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798863
Page 9 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/11/2020
2.Randomization Number: [224903]
3.Randomization Group: [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798864
Page 10 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/11/2020
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 [BPR329]
5.bSample ID [BPR32B]
5.cSample ID [BP5RKK]
5.dSample ID [BP5RKL]
5.eSample ID [BP5RKM]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798865
Page 11 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/11/2020
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 [BP5RKF]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798866
Page 12 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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/11/2020 13:18
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798867
Page 13 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798868
Page 14 of 132
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798869
Page 15 of 132
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?
2.Symptom:
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?
3.Injection Site Location:
4.Injection Site Body Side:
5.Injection Site Reaction:
Were injection site reactions
present on the last day the Subject
Diary was completed?
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798870
Page 16 of 132
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798871
Page 17 of 132
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798872
Page 18 of 132
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798873
Page 19 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798874
Page 20 of 132
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?
2.Symptom:
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?
3.Injection Site Location:
4.Injection Site Body Side:
5.Injection Site Reaction:
Were injection site reactions
present on the last day the Subject
Diary was completed?
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798875
Page 21 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798876
Page 22 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798877
Page 23 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798878
Page 24 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798879
Page 25 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798880
Page 26 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798881
Page 27 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798882
Page 28 of 132
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798883
Page 29 of 132
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798884
Page 30 of 132
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798885
Page 31 of 132
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798886
Page 32 of 132
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798887
Page 33 of 132
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798888
Page 34 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798889
Page 35 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798890
Page 36 of 132
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/14/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/14/2020
2.Erroneous Visit
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798891
Page 37 of 132
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/14/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798892
Page 38 of 132
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/14/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/14/2020
Contact Outcome:
VISIT NOT ARRANGED, UNABLE TO ATTEND
3.Comments: [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798893
Page 39 of 132
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Aug/14/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798894
Page 40 of 132
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Aug/14/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798895
Page 41 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798896
Page 42 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798897
Page 43 of 132
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Identifi
erAdverse Eve
ntStart DateIs the Adverse Event Still Ong
oingForm Instance
 1.ADVERSE EVE
NT 1  Diarrhea  Aug/12/2020 UNK:U
NK NO
End Date Time:
Aug/14/2020 UNK:UNK
 Repeating
Pages
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798898
Page 44 of 132
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[Diarrhea]
4.Start Date Time: Aug/12/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/14/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798899
Page 45 of 132
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798900
Page 46 of 132
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798901
Page 47 of 132
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798902
Page 48 of 132
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798903
Page 49 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: //
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798904
Page 50 of 132
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798905
Page 51 of 132
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798906
Page 52 of 132
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798907
Page 53 of 132
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798908
Page 54 of 132
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798909
Page 55 of 132
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798910
Page 56 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798911
Page 57 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798912
Page 58 of 132
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798913
Page 59 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798914
Page 60 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798915
Page 61 of 132
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798916
Page 62 of 132
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798917
Page 63 of 132
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798918
Page 64 of 132
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798919
Page 65 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798920
Page 66 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798921
Page 67 of 132
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Done
//Comments
2.Primary Reason for Unblinding: Not Done Comments
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798922
Page 68 of 132
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Aug/14/2020
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798923
Page 69 of 132
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798924
Page 70 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Aug/14/2020
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798925
Page 71 of 132
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798926
Page 72 of 132
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Paul Bradley  Approved Oct-30-2020 14:16:59 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulBradley, 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.
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798927
Page 73 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormAug-11-2020 16:18:35 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798928
Page 74 of 132
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormAug-24-2020 13:08:56 (UTC-05:00) Eastern Time
(US & Canada)Not Done
FormAug-24-2020 13:08:27 (UTC-05:00) Eastern Time
(US & Canada)
FormAug-24-2020 10:52:12 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798929
Page 75 of 132
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Aug-24-2020 13:08:56 (UTC-05:00) Eastern Time
(US & Canada)Not Done
1Aug-24-2020 13:08:27 (UTC-05:00) Eastern Time
(US & Canada)
1Aug-24-2020 10:52:12 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798930
Page 76 of 132
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Aug-24-2020 13:08:56 (UTC-05:00) Eastern Time
(US & Canada)Not Done
2Aug-24-2020 13:08:27 (UTC-05:00) Eastern Time
(US & Canada)
2Aug-24-2020 10:52:12 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798931
Page 77 of 132
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormSep-01-2020 13:46:27 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
FormAug-25-2020 20:29:09 (UTC-05:00) Eastern Time
(US & Canada)
FormAug-24-2020 10:51:57 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798932
Page 78 of 132
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Sep-01-2020 13:46:27 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
1Sep-01-2020 13:46:13 (UTC-05:00) Eastern Time
(US & Canada)Death has not occurred so this page is not needed.
Not Applicable
1Aug-25-2020 20:29:09 (UTC-05:00) Eastern Time
(US & Canada)
1Aug-24-2020 10:51:57 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798933
Page 79 of 132
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Paul Bradley  Approved Oct-30-2020 14:16:59 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulBradley, 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-23-2020 15:18:28 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Bradley  Approved Oct-22-2020 17:25:25 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulBradley, 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-22-2020 14:55:37 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Bradley  Approved Oct-22-2020 13:10:13 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798934
Page 80 of 132
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Affidavit:
By my dated signature below, I, PaulBradley, 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-21-2020 14:00:57 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Bradley  Approved Sep-23-2020 18:05:24 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulBradley, 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.
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798935
Page 81 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-11-2020 16:17:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-11-2020 16:17:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798936
Page 82 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-11-2020 16:17:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/11/2020Initial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798937
Page 83 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-11-2020 16:17:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11201127Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-11-2020 16:17:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1945Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-11-2020 16:18:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-11-2020 16:18:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-11-2020 16:18:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798938
Page 84 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-11-2020 16:18:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798939
Page 85 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-11-2020 16:19:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-11-2020 16:19:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-11-2020 16:19:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798940
Page 86 of 132
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Aug-11-2020 16:20:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Allergy to Allbu
terol
Start Date: UNK/UNK/202
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-11-2020 16:20:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 16:20:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Allergy to AllbuterolInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-17-2020 09:05:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Per site confirmation
Aug-17-2020 08:38:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Confirm Medical
History occurred
prior to vaccination
even on same day
(date 11/Aug/2020).
Aug-14-2020 05:15:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM Query: Thank
you for your
response. Please
confirm if Medical
History occurred
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798941
Page 87 of 132
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
prior to vaccination
even on same day
(date 11/Aug/2020).
Please review and
update as
appropriate.
Aug-13-2020 11:25:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Date was sometime
prior to 11Aug2020.
Subject unsure of
exact date.
Aug-11-2020 16:32:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
11/Aug/2020. Please
review and update as
appropriate.
Aug-11-2020 16:20:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-11-2020 16:20:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-11-2020 16:21:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:Chronic obstructive p
ulmonary disease
Start Date: UNK/UNK/1990
Ongoing: YESInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798942
Page 88 of 132
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Line/MH Number:
Date Location User Value Reason
Aug-11-2020 16:21:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 16:21:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Chronic obstructive pulmonary dise
aseInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-11-2020 16:21:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-11-2020 16:21:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-11-2020 16:21:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:Gastroesophageal re
flux disease
Start Date: UNK/UNK/1990
Ongoing: YESInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798943
Page 89 of 132
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.c Line/MH Number:
Date Location User Value Reason
Aug-11-2020 16:21:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 16:21:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Gastroesophageal reflux diseaseInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-11-2020 16:21:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-11-2020 16:21:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-11-2020 16:22:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:hyperlipidemia
Start Date: UNK/UNK/20
05
Ongoing: YESInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798944
Page 90 of 132
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.d Line/MH Number:
Date Location User Value Reason
Aug-11-2020 16:22:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 16:22:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
hyperlipidemiaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-11-2020 16:22:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-11-2020 16:22:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-11-2020 16:23:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:Post Traumatic stre
ss disorder
Start Date: Jan/UNK/2020
Ongoing: YESInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798945
Page 91 of 132
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.e Line/MH Number:
Date Location User Value Reason
Aug-11-2020 16:23:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 16:23:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Post Traumatic stress disorderInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-11-2020 16:23:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-11-2020 16:23:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798946
Page 92 of 132
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Aug-11-2020 16:27:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-11-2020 16:27:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
130.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-11-2020 16:27:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-11-2020 16:27:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
189.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-11-2020 16:27:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-11-2020 16:27:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
36.5Initial Entry
7.a
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0798947
Page 93 of 132
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-11-2020 16:27:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 37.3
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-11-2020 16:27:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-11-2020 16:27:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
37.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-11-2020 16:27:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-11-2020 16:27:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0798948
Page 94 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-11-2020 16:27:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-11-2020 16:27:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
224903Initial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798949
Page 95 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-11-2020 16:27:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020 16:27:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-11-2020 16:28:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-11-2020 16:27:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-11-2020 16:27:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-11-2020 16:28:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPR329Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798950
Page 96 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-11-2020 16:28:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPR329Initial Entry
5.b
Date Location User Value Reason
Aug-11-2020 16:28:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPR32BInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-11-2020 16:28:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPR32BInitial Entry
5.c
Date Location User Value Reason
Aug-11-2020 16:29:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP5RKKInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-11-2020 16:29:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP5RKKInitial Entry
5.d
Date Location User Value Reason
Aug-11-2020 16:29:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP5RKLInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0798951
Page 97 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.d Sample ID
Date Location User Value Reason
Aug-11-2020 16:29:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP5RKLInitial Entry
5.e
Date Location User Value Reason
Aug-11-2020 16:29:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP5RKMInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-11-2020 16:29:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP5RKMInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798952
Page 98 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-11-2020 16:29:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020 16:29:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-11-2020 16:31:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-11-2020 16:29:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-11-2020 16:29:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-11-2020 16:31:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP5RKFInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798953
Page 99 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-11-2020 16:31:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP5RKFInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798954
Page 100 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-11-2020 16:32:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-11-2020 16:32:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-11-2020 16:32:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-19-2020 01:47:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-18-2020 09:51:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Aug-18-2020 06:17:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened PDQ: Subject has
reported severe
symptoms/reaction in
eDiary data on
13Aug2020. Please
confirm if an
UNPLANNED
contact was made and
update the data as
appropriate.
Aug-11-2020 16:32:03
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
Aug/11/2020 13:18Initial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0798955
Page 101 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
5. Anatomical Location:
Date Location User Value Reason
Aug-11-2020 16:32:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-11-2020 16:32:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-11-2020 16:32:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-11-2020 16:32:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-11-2020 16:32:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798956
Page 102 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-11-2020 16:32:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIA
RY COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798957
Page 103 of 132
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/14/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-18-2020 09:48:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798958
Page 104 of 132
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/14/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Assessments
Date Location User Value Reason
Aug-18-2020 09:50:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-18-2020 09:48:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update as
appropriate.
Aug-18-2020 09:48:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798959
Page 105 of 132
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/14/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Contact Type:
Date Location User Value Reason
Aug-18-2020 09:50:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Aug-18-2020 09:50:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Aug/14/2020
Contact Outcome:
VISIT NOT ARRANGED, UNA
BLE TO ATTENDInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798960
Page 106 of 132
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User ValueReason
Oct-23-2020
21:36:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_DS001_14_AN
Oct-23-2020
15:20:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ans
weredChanged Information
Oct-23-2020
15:20:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Aug/1
4/202
0Changed Information
Oct-22-2020
21:45:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5141290;‘Treatment
Date of
Completion/Discontinuation
/Death' is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Oct-22-2020
13:02:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Aug/1
7/202
0Transcription Error
Aug-22-2020
17:31:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Aug/1
4/202
0Initial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0798961
Page 107 of 132
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2. Phase of Disposition:
Date Location User Value Reason
Aug-22-2020 17:31:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-28-2020 02:44:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Closed Response satisfies
query
Oct-27-2020 17:07:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Answered erased
Oct-27-2020 17:06:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Oct-27-2020 17:06:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ADVERSE EVENTChanged Information
Oct-23-2020 15:21:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto Query
Oct-23-2020 15:18:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened Response to "Status"
is WITHDRAWAL
BY SUBJECT but
"Specify Status" is
missing.
Oct-23-2020 15:18:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WITHDRAWAL BY SUBJECTChanged Information
Oct-22-2020 02:29:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Oct-21-2020 14:05:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered UPDATED
Oct-19-2020 22:59:35
(UTC-05:00) EasternACV0PFEINFP6000  Katherine Puig Query 3: Opened DM: Although AE
Diarrhea with start
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0798962
Page 108 of 132
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada) date 12-Aug-2020
overlapped with
e-Diary occurrence of
Diarrhea reported on
12-Aug-2020, this AE
will still need to be
captured in Inform if
it resulted in
discontinuation.
Please review and
correct as appropriate.
Oct-13-2020 17:00:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Katherine Liau Query 2: Closed GPD CLIN: no
corresponding AE as
this is a diary
symptom, awaiting
study team decision to
keep reason for EOT
as "AE".
Oct-13-2020 14:12:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered The subject withdraw
due to sever diarrhea,
it was collect as a AE
but was determined
not to be AE because
it was captured in
diary
Oct-06-2020 15:28:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Opened CLINQUERY:
Reason for Treatment
Discontinuation is
ADVERSE EVENT.
However, there are no
AEs reported for this
subject. Please review
if another status entry
better fits the reason
this subject did not
continue
Aug-24-2020 13:09:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ADVERSE EVENTChanged Information
Aug-22-2020 17:33:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-22-2020 17:31:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Response to "Status"
is REFUSED
FURTHER STUDY
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0798963
Page 109 of 132
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
PROCEDURES but
"Specify Status" is
Provided.
Aug-22-2020 17:31:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
REFUSED FURTHER STUDY P
ROCEDURESInitial Entry
4. Specify Status:
Date Location User Value Reason
Oct-27-2020 17:06:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Changed Information
Oct-23-2020 15:21:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
withdrew by subject due to reaction
of medicationInitial Entry
Aug-22-2020 17:33:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Changed Information
Aug-22-2020 17:31:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Subject experience server diarrhea a
nd decided to discontinue in studyInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0798964
Page 110 of 132
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-15-2020 12:55:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-15-2020 12:55:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2020Transcription Error
Sep-15-2020 12:55:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form is after
"Withdrawal of consent"
date. Please review and
correct as appropriate.
Sep-15-2020 12:55:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-15-2020 12:55:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Oct-28-2020 09:54:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Oct-28-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Oct-28-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ADVERSE EVENTNew Information
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798965
Page 111 of 132
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-16-2020 06:10:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-15-2020 12:56:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Sep-15-2020 12:55:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to "Status"
is WITHDRAWAL
BY SUBJECT but
"Specify Status" is
missing.
Sep-15-2020 12:55:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Sep-15-2020 12:55:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WITHDRAWAL BY SUBJECTInitial Entry
Sep-10-2020 16:24:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Erica Weaver Query 1: Opened Please enter FUP
disposition
4. Specify Status:
Date Location User Value Reason
Oct-29-2020 20:53:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-28-2020 09:54:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-28-2020 09:54:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: New Information
Oct-28-2020 00:33:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
update as appropriate.
Thanks.
Sep-15-2020 12:56:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
subject withdrew from studyInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0798966
Page 112 of 132
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Oct-21-2020 14:00:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Undeleted PER QUERY
Sep-17-2020 16:14:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Aug-18-2020 09:56:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798967
Page 113 of 132
***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, Locked, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Aug-18-2020 09:56:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Aug-18-2020 09:56:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-18-2020
10:50:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Clos
edData deleted
Sep-17-2020
21:00:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Salim Bouguermouh Query 2: Clos
edResponse
satisfies query
Sep-17-2020
16:14:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Ans
weredTranscription
Error
Sep-17-2020
08:18:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 3: Ope
nedeDiary: AE
Diarrhea
reported with
start date
12-Aug-2020
and End Date
null seems to be
same as e-Diary
occurrence
Diarrhea
reported on
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0798968
Page 114 of 132
***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, Locked, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
12-Aug-2020.
Please reconcile
or confirm in
the query
response as
appropriate.
Sep-16-2020
13:28:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Ans
weredChanged data
per query
Sep-16-2020
09:20:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Salim Bouguermouh Query 2: Reis
sued:OpenedClin: Please
update the AE
CRF form as
RELATED to
study vaccine.
Sep-15-2020
12:58:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Ans
weredvaccine
reactogenicity
Sep-09-2020
01:36:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Ope
nedClin: Per PA5
Sections 8.1.,
8.3.7, 8.13.,
please review if
the ongoing
“Diarrhea” a
COVID-19
listed
symptoms, start
date 1d post
Dose 1, is more
related to
Covid-19 (and
should trigger a
COVID Illness
Visit) or is due
to vaccine
reactogenicity
Sep-09-2020
01:29:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Salim Bouguermouh Query 2: Can
didateClin: Per PA5
Sections 8.1.,
8.3.7, 8.13.,
please review if
the ongoing
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0798969
Page 115 of 132
***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, Locked, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
“Diarrhea” a
COVID-19
listed
symptoms, start
date 1d post
Dose 1, is more
related to
Covid-19 (and
should trigger a
COVID Illness
Visit) or is due
to vaccine
reactogenicity
Aug-24-2020
03:21:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Clos
edResponse
satisfies query
Aug-22-2020
17:25:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Ans
weredYes diarrhea
that was
reported in
e-diary as
severe
Aug-22-2020
02:44:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Ope
nede-Diary: AE
‘Diarrhea'
seems to be
same as e-Diary
Pain at Diarrhea
Occurrence
reported. Please
reconcile or
confirm in the
query response
as appropriate
Aug-18-2020
09:56:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DiarrheaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Aug-18-2020 09:56:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020 UNK:UNKInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0798970
Page 116 of 132
***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, Locked, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5. Is the adverse event still ongoing?
Date Location User ValueReason
Oct-22-2020
21:48:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
3: Clo
sedAuto closed by Validation
Check: VC_AE001_10_AN
Oct-22-2020
14:55:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
3: Ans
weredNew Information
Oct-22-2020
14:55:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
NO
End
Date
Tim
e:
Au
g/1
4/2
02
0
U
N
K:
U
N
KNew Information
Oct-22-2020
14:23:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Rei
ssued:
Opene
dDMW5127349;‘End Date'
17AUG2020 is after ‘Date
of
Completion/Discontinuation
/Death’ 14AUG2020 on the
Disposition - Follow-up
eCRF. Updated was noted
on Query response.
However, updates were not
made, please re-evaluate.
Thank you!
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0798971
Page 117 of 132
***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, Locked, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-22-2020
13:07:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Ans
weredUPDATED
Oct-21-2020
22:46:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
3: Op
enedDMW5127349;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Oct-21-2020
14:04:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Clo
sedClose Auto Query
Oct-21-2020
14:04:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
NO
End
Date
Tim
e:
Au
g/1
7/2
02
0
U
N
K:
U
N
KNew Information
Oct-21-2020
14:00:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Op
ened'Disposition Follow-up
form is completed and this
Adverse Event is still
ongoing. Please review and
update as appropriate.
Sep-16-2020
09:57:22ACV0PFEINFP6000  Query
1: CloResponse satisfies query
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0798972
Page 118 of 132
***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, Locked, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time
(US &
Canada)sed
Sep-15-2020
12:58:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredstill ongoing as per last
contact with subject
Sep-15-2020
12:55:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Op
ened'Disposition Follow-up
form is completed and this
Adverse Event is still
ongoing. Please review and
update as appropriate.
Aug-18-2020
09:56:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Aug-18-2020 09:56:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Aug-18-2020 09:56:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0798973
Page 119 of 132
***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, Locked, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-18-2020 09:56:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-16-2020 13:28:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDChanged Information
Aug-18-2020 09:56:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
UnknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-28-2020 11:27:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Ahmed
HassanQuery 1: Closed Response satisfies
query
Oct-28-2020 09:54:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-28-2020 09:54:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNNew Information
Oct-28-2020 05:59:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Ahmed
HassanQuery 1: Opened ClinQuery: The EOT
page states subject
was withdrawn due
to AE, however,
question 10 on the
AE log states 'not
applicable'. please
review this question's
answer and update as
appropriate. thanks
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0798974
Page 120 of 132
***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, Locked, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-18-2020 09:56:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Aug-18-2020 09:56:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Aug-18-2020 09:56:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-21-2020 14:04:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-21-2020 14:04:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Oct-21-2020 14:04:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Diarrhea:
Response to "What was
the outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Aug-18-2020 09:56:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-29-2020 20:52:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0798975
Page 121 of 132
***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, Locked, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-28-2020 09:55:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered updated
Oct-28-2020 07:03:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Closed Clin query present
forms already
unlocked
Oct-28-2020 00:34:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened ClinQuery: FUP
DISP form is
unlocked now. Please
update as
appropriate. Thanks.
Oct-27-2020 17:07:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered was able to update
EOT BUT DISP
form is still locked
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0798976
Page 122 of 132
***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, Locked, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-27-2020 16:11:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened This adverse event of
Diarrhia indicates that
it caused the subject
to discontinue the
trial. However, the
End of Treatment
page does not indicate
ADVERSE EVENT,
please consider
updating accordingly
- see CRF
Completion GLs.
Thank You!
Oct-27-2020 15:39:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered The disposition pages
are lock please unlock
to update
Oct-26-2020 20:03:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened ClinQuery: please
update the specify
status field in FUP
page to indicate the
PRIMARY reason for
discontinuation.
thanks
Oct-26-2020 14:20:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Please unlock page
Oct-24-2020 06:25:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened 'Did the adverse event
cause the subject to
be discontinued from
the study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Oct-23-2020 16:04:38 ACV0PFEINFP6000  Query 2: Answered an ae did occur but
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0798977
Page 123 of 132
***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, Locked, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00) Eastern
Time (US & Canada)subject withdrew due
to ae
Oct-23-2020 15:18:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate 'Did the adverse event
cause the subject to
be discontinued from
the study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Oct-22-2020 21:00:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened ClinQuery: Diarrhea
is listed to have
caused the subject to
be discontinued,
however, the FUP
page states the reason
for discontiuation is
withdrawal by
subject. Please
review/update as
appropriate.
Aug-25-2020 04:11:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted related query present.
Aug-24-2020 13:09:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Did the adverse event
cause the subject to
be discontinued from
the study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Aug-24-2020 02:18:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: 'Did the adverse
event cause the
subject to be
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0798978
Page 124 of 132
***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, Locked, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Aug-22-2020 17:31:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Did the adverse event
cause the subject to
be discontinued from
the study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Aug-19-2020 07:59:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM query: 'Did the
adverse event cause
the subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Aug-18-2020 09:56:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Did the adverse event
cause the subject to
be discontinued from
the study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798979
Page 125 of 132
***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, Locked, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Aug-18-2020 09:56:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798980
Page 126 of 132
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Aug-24-2020 13:08:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Aug-24-2020 13:08:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Aug-24-2020 10:52:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Aug-24-2020 13:08:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Aug-24-2020 13:08:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Aug-24-2020 10:52:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0798981
Page 127 of 132
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Aug-24-2020 10:51:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798982
Page 128 of 132
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Sep-03-2020
00:35:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
ClosedPer site
confirmation-Form
NA
Sep-02-2020
11:10:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
AnsweredNot applicable has
been entered for this
page.
Sep-02-2020
02:46:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 2:
OpenedDMW4438713;Date of
Collection/Notification
of Death is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Sep-01-2020
13:46:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Ent
ry:
Not Appli
cableInitial Entry
Aug-26-2020
01:46:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
ClosedAuto closed by
Validation Check:
VC_DD002_01
Aug-25-2020
20:30:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
AnsweredNo data needed
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0798983
Page 129 of 132
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-25-2020
20:29:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Ent
ry:Initial Entry
Aug-25-2020
05:27:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
OpenedDMW4338139;Date of
Collection/Notification
of Death is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Aug-24-2020
10:51:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Ent
ry:
Not Appli
cableInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0798984
Page 130 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-28-2020 09:54:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDNew Information
Oct-27-2020 17:06:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged Information
Oct-23-2020 15:18:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged Information
Sep-15-2020 12:55:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Aug-24-2020 13:09:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged Information
Aug-22-2020 17:31:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Aug-11-2020 16:27:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-11-2020 16:19:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-28-2020 09:54:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/14/2020New Information
Oct-27-2020 17:06:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/14/2020Changed Information
Oct-23-2020 15:20:47
(UTC-05:00) Eastern TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/14/2020Changed Information
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798985
Page 131 of 132
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(US & Canada)
Oct-23-2020 15:18:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/14/2020Changed Information
Oct-22-2020 13:02:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/14/2020Transcription Error
Sep-15-2020 12:55:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/14/2020Transcription Error
Sep-15-2020 12:55:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/17/2020Initial Entry
Aug-24-2020 13:09:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/14/2020Changed Information
Aug-22-2020 17:31:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
Aug-11-2020 16:27:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/11/2020Initial Entry
Aug-11-2020 16:19:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/11/2020Initial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798986
Page 132 of 132
***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, Signed, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-23-2020 14:00:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3ff6\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798987