125742 S1 M5 CRF c4591001 1120 11201432

Document text

Page 1 of 210
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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 version06 OCT 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799694
Page 2 of 210
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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
Oct/30/2020
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799695
Page 3 of 210
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11201432]
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:
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799696
Page 4 of 210
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799697
Page 5 of 210
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799698
Page 6 of 210
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799699
Page 7 of 210
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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:[HYPERLIPIDEMIA]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HYPERTENSION]
Start Date: Feb/14/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[INSOMNIA]
Start Date: UNK/UNK/2008
Ongoing: YES
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799700
Page 8 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[SEASONAL ALLERGIES]
Start Date: UNK/UNK/2012
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[BILATERAL ANKLES OSTEOARTHRITIS]
Start Date: UNK/UNK/2018
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[BACK SPASMS]
Start Date: UNK/UNK/2008
Ongoing: YES
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799701
Page 9 of 210
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799702
Page 10 of 210
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/30/2020
2.Weight: [84.2]
3.Unit: kg
4.Height: [169.0]
5.Unit: cm
6.Body Mass Index: [29.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799703
Page 11 of 210
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/30/2020
2.Randomization Number: [273736]
3.Randomization Group: [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799704
Page 12 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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:
Oct/30/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8VML]
5.bSample ID [BMN8CG]
5.cSample ID [BMN8CH]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799705
Page 13 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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:
Oct/30/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8VMK]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799706
Page 14 of 210
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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: Oct/30/2020 14:23
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799707
Page 15 of 210
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799708
Page 16 of 210
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/20/2020
2.Erroneous Visit
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799709
Page 17 of 210
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?YES
Ongoing?
NO
Stop Date:
Nov/6/2020
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799710
Page 18 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799711
Page 19 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799712
Page 20 of 210
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Nov/20/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799713
Page 21 of 210
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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:
Nov/20/2020
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 [BP8VTR]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799714
Page 22 of 210
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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: Nov/20/2020 11:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799715
Page 23 of 210
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799716
Page 24 of 210
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?Not Applicable Comments
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799717
Page 25 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799718
Page 26 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
3.Injection Site Location: Not Applicable Comments
4.Injection Site Body Side: Not Applicable Comments
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?Not Applicable Comments
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?Not Applicable Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?Not Applicable Comments
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799719
Page 27 of 210
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799720
Page 28 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799721
Page 29 of 210
***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: 11201432 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 [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799722
Page 30 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799723
Page 31 of 210
***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: 11201432 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 [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799724
Page 32 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799725
Page 33 of 210
***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: 11201432 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 [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799726
Page 34 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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:
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799727
Page 35 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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: [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799728
Page 36 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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 [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799729
Page 37 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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 [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799730
Page 38 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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?
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799731
Page 39 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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:
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799732
Page 40 of 210
***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: 11201432 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:
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799733
Page 41 of 210
***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: 11201432 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 [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799734
Page 42 of 210
***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: 11201432 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:
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799735
Page 43 of 210
***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: 11201432 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 [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799736
Page 44 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Iden
tifierAdverse E
ventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Pancreatic
cancer Dec/4/2020 U
NK:UNK YES  Repeating
Pages
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799737
Page 45 of 210
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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)[Pancreatic cancer]
4.Start Date Time: Dec/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 4
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799738
Page 46 of 210
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799739
Page 47 of 210
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020492177]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799740
Page 48 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799741
Page 49 of 210
***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: 11201432 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[ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799742
Page 50 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799743
Page 51 of 210
***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: 11201432 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: //
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799744
Page 52 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799745
Page 53 of 210
***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: 11201432 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?
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799746
Page 54 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799747
Page 55 of 210
***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: 11201432 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?
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799748
Page 56 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799749
Page 57 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799750
Page 58 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Nov/06/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799751
Page 59 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Nov/06/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799752
Page 60 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Nov/06/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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:
Nov/6/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799753
Page 61 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799754
Page 62 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11201432 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:
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799755
Page 63 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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?
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799756
Page 64 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799757
Page 65 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799758
Page 66 of 210
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799759
Page 67 of 210
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799760
Page 68 of 210
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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 [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799761
Page 69 of 210
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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 [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799762
Page 70 of 210
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799763
Page 71 of 210
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799764
Page 72 of 210
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799765
Page 73 of 210
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799766
Page 74 of 210
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/12/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799767
Page 75 of 210
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent
Date :Not Applicable
//Comments
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799768
Page 76 of 210
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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
[ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799769
Page 77 of 210
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799770
Page 78 of 210
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799771
Page 79 of 210
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799772
Page 80 of 210
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799773
Page 81 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status ENROLLED/RANDOMIZED
2.Subject Status Date Oct/30/2020
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799774
Page 82 of 210
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Casebook Signature Form
1.Casebook Signature
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799775
Page 83 of 210
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799776
Page 84 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-30-2020 15:27:32 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799777
Page 85 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-12-2021 11:30:06 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799778
Page 86 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-12-2021 11:30:06 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799779
Page 87 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Mar-12-2021 11:30:06 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799780
Page 88 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-12-2021 11:30:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799781
Page 89 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-12-2021 11:30:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799782
Page 90 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.aMar-12-2021 11:30:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799783
Page 91 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.bMar-12-2021 11:30:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799784
Page 92 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.cMar-12-2021 11:30:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799785
Page 93 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.dMar-12-2021 11:30:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799786
Page 94 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.eMar-12-2021 11:30:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799787
Page 95 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.fMar-12-2021 11:30:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799788
Page 96 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.gMar-12-2021 11:30:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799789
Page 97 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.hMar-12-2021 11:30:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799790
Page 98 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Mar-12-2021 11:30:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799791
Page 99 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Mar-12-2021 11:30:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799792
Page 100 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aMar-12-2021 11:30:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799793
Page 101 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bMar-12-2021 11:30:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799794
Page 102 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cMar-12-2021 11:30:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799795
Page 103 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-12-2021 11:30:40 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799796
Page 104 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-12-2021 11:30:40 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799797
Page 105 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Mar-12-2021 11:30:40 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799798
Page 106 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Mar-12-2021 11:30:40 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799799
Page 107 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Mar-12-2021 11:30:40 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799800
Page 108 of 210
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormJan-22-2021 07:59:54 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799801
Page 109 of 210
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Jan-22-2021 07:59:54 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799802
Page 110 of 210
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormJan-22-2021 08:00:06 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799803
Page 111 of 210
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Jan-22-2021 08:00:06 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799804
Page 112 of 210
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799805
Page 113 of 210
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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
Oct-30-2020
15:26:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-30-2020
15:26:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799806
Page 114 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-30-2020
15:27:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent
Obtained
Oct/30/2020Initial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799807
Page 115 of 210
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-30-2020
15:26:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11201432Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-30-2020
15:26:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1945Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-30-2020
15:27:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799808
Page 116 of 210
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-30-2020
15:27:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR L
ATINO(A) OR OF SP
ANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-30-2020
15:27:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799809
Page 117 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-03-2020
02:28:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed SWAB PFE
and SAMP
TRK forms
are updated.
Nov-02-2020
16:45:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered UPDATED
Nov-02-2020
05:43:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly
consider to
update
missing
SWAB PFE
and SAMP
TRK forms or
else clarify.
Thank you.
Oct-30-2020
15:27:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799810
Page 118 of 210
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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
Oct-30-2020
15:27:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-30-2020
15:27:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-30-2020
15:27:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799811
Page 119 of 210
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Oct-30-2020
15:28:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:HYPERL
IPIDEMI
A
Start Date: UNK/UN
K/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-30-2020
15:28:01
(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
Oct-30-2020
15:28:01
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
HYPERLIPIDEMIAInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799812
Page 120 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
& Canada)
1.a Start Date:
Date Location User Value Reason
Oct-30-2020
15:28:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-30-2020
15:28:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-30-2020
15:28:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical Hi
story Term:HYPERT
ENSION
Start Date: Feb/14/2
020
Ongoing: YESInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799813
Page 121 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Line/MH Number:
Date Location User Value Reason
Oct-30-2020
15:28:19
(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
Oct-30-2020
15:28:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HYPERTENSIONInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-30-2020
15:28:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/14/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-30-2020
15:28:19ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799814
Page 122 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
1.c
Date Location User Value Reason
Oct-30-2020
15:28:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:INSOM
NIA
Start Date: UNK/U
NK/2008
Ongoing: YESInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799815
Page 123 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.c Line/MH Number:
Date Location User Value Reason
Oct-30-2020
15:28:32
(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
Oct-30-2020
15:28:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
INSOMNIAInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-30-2020
15:28:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-30-2020
15:28:32ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799816
Page 124 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
1.d
Date Location User Value Reason
Oct-30-2020
15:28:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History T
erm:SEASON
AL ALLE
RGIES
Start Dat
e:UNK/UN
K/2012
Ongoing: YESInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799817
Page 125 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.d Line/MH Number:
Date Location User Value Reason
Oct-30-2020
15:28:44
(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
Oct-30-2020
15:28:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SEASONAL ALLERG
IESInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-30-2020
15:28:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-30-2020
15:28:44ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799818
Page 126 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
1.e
Date Location User Value Reason
Oct-30-2020
15:29:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:5
Medica
l Histor
y Term
:BILATERAL
ANKLES OS
TEOARTHR
ITIS
Start D
ate:UNK/UNK/2
018
Ongoin
g:YESInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799819
Page 127 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.e Line/MH Number:
Date Location User Value Reason
Oct-30-2020
15:29:05
(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
Oct-30-2020
15:29:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BILATERAL ANKLE
S OSTEOARTHRITISInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-30-2020
15:29:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-30-2020
15:29:05ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799820
Page 128 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
1.f
Date Location User Value Reason
Oct-30-2020
15:29:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical His
tory Term:BACK S
PASMS
Start Date: UNK/U
NK/2008
Ongoing: YESInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799821
Page 129 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.f Line/MH Number:
Date Location User Value Reason
Oct-30-2020
15:29:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-30-2020
15:29:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BACK SPASMSInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-30-2020
15:29:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-30-2020
15:29:21ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799822
Page 130 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799823
Page 131 of 210
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-30-2020
15:29:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT kn
own to be HIV POSITI
VEInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799824
Page 132 of 210
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-30-2020
15:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-30-2020
15:32:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
84.2Transcription
Error
Oct-30-2020
15:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
185.8Initial Entry
3. Unit:
Date Location User Value Reason
Oct-30-2020
15:32:32
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799825
Page 133 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)
Oct-30-2020
15:32:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
kgTranscription
Error
Oct-30-2020
15:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened lb is selected
for weight unit,
then in is
expected to be
selected for
Height unit.
Please check
and update data
as appropriate.
Oct-30-2020
15:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-30-2020
15:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
169.0Initial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799826
Page 134 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5. Unit:
Date Location User Value Reason
Oct-30-2020
15:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-30-2020
15:32:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29.5Transcription
Error
Oct-30-2020
15:32:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription
Error
Oct-30-2020
15:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
7.a
Date Location User Value Reason
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799827
Page 135 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-30-2020
15:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.9
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-30-2020
15:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-30-2020
15:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799828
Page 136 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-30-2020
15:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-30-2020
15:29:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799829
Page 137 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-30-2020
15:30:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-30-2020
15:30:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
273736Initial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799830
Page 138 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-02-2020
16:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-02-2020
16:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020
16:44:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-02-2020
16:44:22
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799831
Page 139 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-02-2020
16:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Nov-02-2020
16:44:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP8VM
LInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-02-2020
16:44:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8VMLInitial Entry
5.b
Date Location User Value Reason
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799832
Page 140 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-02-2020
16:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BMN8C
GInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-02-2020
16:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMN8CGInitial Entry
5.c
Date Location User Value Reason
Nov-02-2020
16:44:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BMN8C
HInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-02-2020
16:44:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMN8CHInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799833
Page 141 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-02-2020
16:45:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-02-2020
16:45:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020
16:45:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-02-2020
16:45:03
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799834
Page 142 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-02-2020
16:45:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Nov-02-2020
16:45:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP8VM
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-02-2020
16:45:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8VMKInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799835
Page 143 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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
Oct-30-2020
15:30:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-30-2020
15:30:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-30-2020
15:30:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799836
Page 144 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-30-2020
15:30:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/30/2020 14:23Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-30-2020
15:30:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-30-2020
15:30:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-30-2020
15:30:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799837
Page 145 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-30-2020
15:30:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-30-2020
15:30:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799838
Page 146 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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
Oct-30-2020
15:31:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENI
CITY E-DIARY COL
LECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799839
Page 147 of 210
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-24-2020
09:05:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/20/2020Initial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799840
Page 148 of 210
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-26-2020
00:57:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Data updated
by site
Nov-25-2020
09:26:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dNew
Information
Nov-25-2020
09:26:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Nov/6/2020New
Information
Nov-25-2020
02:40:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened eDiary: Per
diary records,
FEVER/PAIN
MED present
on Last day
however
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799841
Page 149 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
inform entered
with 'No' for
the same.
Please verify
and update. If
diary entered in
error, please
enter stop date
as last date of
diary. Thanks.
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:N
OInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799842
Page 150 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.a Symptom:
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
EInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799843
Page 151 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
O
2.b Symptom:
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
ADInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799844
Page 152 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)AC
HE
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NO
2.c Symptom:
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799845
Page 153 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
LS
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799846
Page 154 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799847
Page 155 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.f
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799848
Page 156 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.f Symptom:
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
INInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799849
Page 157 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.g Symptom:
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Nov-24-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0799850
Page 158 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:NO
2.h Symptom:
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799851
Page 159 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
3. Injection Site Location:
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Re
action::RE
D
NE
SSInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799852
Page 160 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were injection si
te reactions pres
ent on the last da
y the Subject Dia
ry was complete
d?:N
O
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Injection Site Re
action::SW
ELInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799853
Page 161 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799854
Page 162 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTIO
N SI
TE
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-24-2020
09:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799855
Page 163 of 210
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Nov-24-2020
09:07:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/20/2020Initial Entry
2.a
Date Location User Value Reason
Nov-24-2020
09:07:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.7
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-24-2020
09:07:28
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799856
Page 164 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
& Canada)
2.a Temperature:
Date Location User Value Reason
Nov-24-2020
09:07:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-24-2020
09:07:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-24-2020
09:07:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799857
Page 165 of 210
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-24-2020
10:55:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-24-2020
10:55:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-24-2020
10:55:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-24-2020
10:55:27
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799858
Page 166 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-24-2020
10:55:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/20/2020Initial Entry
5.a
Date Location User Value Reason
Nov-24-2020
10:55:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8VTRInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-24-2020
10:55:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8VTRInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799859
Page 167 of 210
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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
Nov-24-2020
09:07:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-24-2020
09:07:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-24-2020
09:07:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799860
Page 168 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-24-2020
09:07:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/20/2020 11:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-24-2020
09:07:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-24-2020
09:07:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-24-2020
09:07:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799861
Page 169 of 210
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-24-2020
09:07:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Nov-24-2020
09:07:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799862
Page 170 of 210
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021
11:30:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-12-2021
11:30:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799863
Page 171 of 210
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.a
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Ap
plic
abl
e
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:Not
Ap
plic
abl
eInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799864
Page 172 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.b
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Ap
plic
abl
e
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:Not
Ap
plic
abl
eInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799865
Page 173 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.b Symptom:
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.c
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Ap
plic
abl
eInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799866
Page 174 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:Not
Ap
plic
abl
e
2.c Symptom:
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.d
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
ApInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799867
Page 175 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)plic
abl
e
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:Not
Ap
plic
abl
e
2.d Symptom:
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.e
Date Location User Value Reason
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799868
Page 176 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Ap
plic
abl
e
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:Not
Ap
plic
abl
eInitial Entry
2.e Symptom:
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799869
Page 177 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.f
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Ap
plic
abl
e
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:Not
Ap
plic
abl
eInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799870
Page 178 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.f Symptom:
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.g
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Ap
plic
abl
eInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799871
Page 179 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:Not
Ap
plic
abl
e
2.g Symptom:
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.h
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
ApInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799872
Page 180 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)plic
abl
e
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:Not
Ap
plic
abl
e
2.h Symptom:
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799873
Page 181 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Re
action::Not
Ap
plic
abl
e
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:Not
Ap
plic
abl
eInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799874
Page 182 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a Injection Site Reaction:
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.b
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Re
action::Not
Ap
plic
abl
eInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799875
Page 183 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:Not
Ap
plic
abl
e
5.b Injection Site Reaction:
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.c
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Injection Site Re
action::Not
ApInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799876
Page 184 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)plic
abl
e
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:Not
Ap
plic
abl
e
5.c Injection Site Reaction:
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-12-2021
11:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799877
Page 185 of 210
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021
11:30:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021
11:30:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021
11:30:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799878
Page 186 of 210
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Mar-12-2021
11:30:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799879
Page 187 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Dec-17-2020
13:57:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799880
Page 188 of 210
***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
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Dec-17-2020
13:57:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-17-2020
13:57:08
(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
Dec-17-2020
13:57:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Pancreatic cancerInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799881
Page 189 of 210
***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
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-17-2020
13:57:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/4/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-17-2020
13:57:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-17-2020
13:57:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
4Initial 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).
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799882
Page 190 of 210
***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
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Dec-18-2020
07:08:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-17-2020
13:57:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Pancreatic
cancer :
Response to
"Is the
adverse event
serious?" is
'Yes' but
"Serious
Adverse
Event
Number" is
blank.
Dec-17-2020
13:57:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious even
t associated with c
ongenital anomaly
or birth defect?
NO
Did this serious ev
ent result in death?
NOInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799883
Page 191 of 210
***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
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Did this serious ev
ent require or prol
ong hospitalization
?
NO
Did this serious ev
ent result in persist
ent or significant d
isability/incapacity
?
NO
Is this serious even
t life threatening?
YES
Other medically i
mportant serious e
vent
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.
Date Location User Value Reason
Dec-17-2020
13:57:08
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799884
Page 192 of 210
***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
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-17-2020
13:57:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), th
is event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-17-2020
13:57:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-17-2020
13:57:08ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799885
Page 193 of 210
***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
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-17-2020
13:57:08
(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
Dec-17-2020
13:57:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED
/NOT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-17-2020
13:57:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799886
Page 194 of 210
***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
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Dec-18-2020
07:08:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2020492177Initial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799887
Page 195 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Nov/06/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-09-2020
16:52:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/6/2020Initial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799888
Page 196 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Nov/06/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Assessments
Date Location User Value Reason
Nov-09-2020
16:53:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-09-2020
16:52:47
(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.
Nov-09-2020
16:52:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CONTACT OUTCO
MEInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799889
Page 197 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Nov/06/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Contact Type:
Date Location User Value Reason
Nov-09-2020
16:53:00
(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
Nov-09-2020
16:53:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-09-2020
16:53:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Nov/6/2020
Contact Outcome:
VISIT NOT REQ
UIRED, INVEST
IGATOR DECISI
ONTranscription
Error
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799890
Page 198 of 210
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Nov/06/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-09-2020
16:53:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of Contact
09/Nov/2020 is
not equal to the
Date of Visit
06/Nov/2020
within same
unplanned visit.
Please review
and update as
appropriate.
Nov-09-2020
16:53:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Nov/9/2020
Contact Outcome:
VISIT NOT REQ
UIRED, INVEST
IGATOR DECISI
ONInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799891
Page 199 of 210
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-21-2021
09:16:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/12/2021Initial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799892
Page 200 of 210
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-12-2021
13:19:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Reissue
d:Candidatesubject has not
been vaxed yet
Mar-12-2021
11:32:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Answer
edsubject has not
been vaxed yet
Mar-10-2021
16:15:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Opened DM: Further
Vaccination
Confirmation
has been
completed;
however, EOT
(DISP TRT for
Vaccination
1/2) has not
been
completed.
Please refer to
CRF
Completion
Requirements
Section 8.66,
FAQ #2 and
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799893
Page 201 of 210
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
update
accordingly.
Mar-05-2021
09:54:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Mar-04-2021
09:10:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answer
edsubject
receiving
chemotherapy
Mar-04-2021
01:39:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened DM: Participant
is eligible and
confirmed to
have received
Placebo, but
Date Written
Consent
Obtained is
missing in
Informed
Consent -
Further
Vaccination
CRF. Please
review and
update as
appropriate.
Jan-22-2021
07:59:46ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799894
Page 202 of 210
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time
(US & Canada)
Jan-21-2021
23:58:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-21-2021
09:16:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
teThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-21-2021
09:16:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is will
ing to return for V
accination 3
Participant is:Initial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799895
Page 203 of 210
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eligible per loc
al/national rec
ommendations
and confirmed
to have receiv
ed only placeb
o at Vaccinatio
n 1/2
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799896
Page 204 of 210
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-22-2021
07:59:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/12/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-22-2021
07:59:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONAL
VACCINATIONInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799897
Page 205 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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
Jan-22-2021
07:59:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799898
Page 206 of 210
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201432 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
Jan-22-2021
08:00:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799899
Page 207 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-12-2021
13:06:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clos
edResponse satisfies query
Mar-12-2021
11:31:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ans
weredupdated
Mar-12-2021
07:35:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Reis
sued:O
penedDM: Visit 3 is overdue based
on expected visit window.
Please enter data or, if visit
will never occur, mark Date of
Visit as ‘Not Done’ with form
level comment. If subject is no
longer in the trial, complete
the Disposition FUP form.
Mar-04-2021
20:40:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Reis
sued:C
andidat
epending patient can continue
on study
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799900
Page 208 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Mar-04-2021
09:10:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ans
weredsubject receiving
chemotherapy and waiting to
see if subject can continue on
in study
Mar-02-2021
04:45:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ope
nedDM: Visit 3 is overdue based
on expected visit window.
Please enter data or, if visit
will never occur, mark Date of
Visit as ‘Not Done’ with form
level comment. If subject is no
longer in the trial, complete
the Disposition FUP form.
Mar-01-2021
09:59:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clos
edResponse satisfies query
Feb-26-2021
15:20:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredSUBJECT WAS
UNBLINDED. SUBJECT IS
STILL STAYING IN
FOLLOW UP. SAE WAS
UPDATED AS SUBJECT
WILL CONTINUE IN
STUDY.
Feb-22-2021
22:55:17
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000  Query
1: Ope
nedDM Q: Visit
V3_MONTH1_POSTVAX2_L
was expected to occur on
25-DEC-2020. Please enter
data or confirm reason why
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (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-2021-5683-0799901
Page 209 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Canada) visit has not yet occurred. If
subject is no longer in the trial,
please update the Disposition
Follow Up form accordingly.
Oct-30-2020
15:30:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data E
ntry:
ENRO
LLED/
RAND
OMIZ
EDInitial Entry
Oct-30-2020
15:27:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data E
ntry:
SCRE
ENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-18-2020
07:08:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Cl
osedResponse satisfies query
Dec-17-2020
16:11:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: An
sweredwill update ecrf
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799902
Page 210 of 210
***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: 11201432 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-17-2020
08:39:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Op
enedSAE
RECON:AER#2020492177
Pancreatic cancer(onset
date:04Dec2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-30-2020
15:30:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Initial Entry
Oct-30-2020
15:27:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Initial Entry
090177e196ae3ff8\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799903