125742 S1 M5 CRF c4591001 1093 10931067

Document text

Page 1 of 133
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019865
Page 2 of 133
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/26/2020
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019866
Page 3 of 133
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10931067]
2.Birth Date: 1984
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019867
Page 4 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019868
Page 5 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019869
Page 6 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/26/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019870
Page 7 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[BILATERAL TUBAL LIGATION]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019871
Page 8 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
2.Weight: [151.4]
3.Unit: LB
4.Height: [73.0]
5.Unit: in
6.Body Mass Index: [20.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019872
Page 9 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/26/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019873
Page 10 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/26/2020
2.Randomization Number: [68478]
3.Randomization Group: [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019874
Page 11 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
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 [BP5D4Y]
5.bSample ID [BP5D4Z]
5.cSample ID [BP5D50]
5.dSample ID [BPR67M]
5.eSample ID [BPR67N]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019875
Page 12 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
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 [BPR67P]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019876
Page 13 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/26/2020 14:30
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
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019877
Page 14 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019878
Page 15 of 133
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019879
Page 16 of 133
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019880
Page 17 of 133
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/16/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019881
Page 18 of 133
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
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 [BPR6PJ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019882
Page 19 of 133
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/16/2020 10:07
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
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019883
Page 20 of 133
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019884
Page 21 of 133
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
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 [BSHLPD]
5.bSample ID [BSHLPF]
5.cSample ID [BRD94D]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019885
Page 22 of 133
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019886
Page 23 of 133
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/10/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSHLX9]
5.bSample ID [BSHLXB]
5.cSample ID [BN5HG6]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019887
Page 24 of 133
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019888
Page 25 of 133
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019889
Page 26 of 133
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019890
Page 27 of 133
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019891
Page 28 of 133
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019892
Page 29 of 133
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019893
Page 30 of 133
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019894
Page 31 of 133
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019895
Page 32 of 133
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019896
Page 33 of 133
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019897
Page 34 of 133
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019898
Page 35 of 133
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019899
Page 36 of 133
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019900
Page 37 of 133
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Unplanned Assessments
1.Assessments
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019901
Page 38 of 133
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019902
Page 39 of 133
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019903
Page 40 of 133
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019904
Page 41 of 133
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019905
Page 42 of 133
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still
ongoing?
6.Toxicity Grade:
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).
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019906
Page 43 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with
Study Treatment:
11.Was a Concomitant
Medication given?
12.Was a Non-Drug Treatment
given?
13.What was the outcome of
this adverse event?:
14.Did the adverse event cause
the subject to be
discontinued from the
study?
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019907
Page 44 of 133
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019908
Page 45 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019909
Page 46 of 133
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019910
Page 47 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019911
Page 48 of 133
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019912
Page 49 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019913
Page 50 of 133
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019914
Page 51 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019915
Page 52 of 133
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019916
Page 53 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019917
Page 54 of 133
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019918
Page 55 of 133
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019919
Page 56 of 133
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019920
Page 57 of 133
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019921
Page 58 of 133
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019922
Page 59 of 133
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019923
Page 60 of 133
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019924
Page 61 of 133
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019925
Page 62 of 133
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019926
Page 63 of 133
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019927
Page 64 of 133
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019928
Page 65 of 133
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019929
Page 66 of 133
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/27/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019930
Page 67 of 133
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019931
Page 68 of 133
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019932
Page 69 of 133
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/14/2020
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019933
Page 70 of 133
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019934
Page 71 of 133
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019935
Page 72 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormAug-26-2020 16:14:11 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1019936
Page 73 of 133
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-22-2021 14:20:33 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Ensz  Approved Oct-22-2020 16:44:01 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidEnsz, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019937
Page 74 of 133
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-26-2020
16:13:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-26-2020
16:13:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019938
Page 75 of 133
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-26-2020
16:13:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/26/2020Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019939
Page 76 of 133
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-26-2020
16:13:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10931067Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-26-2020
16:13:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1984Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-26-2020
16:13:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019940
Page 77 of 133
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-26-2020
16:13:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-26-2020
16:13:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019941
Page 78 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-26-2020
16:14:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019942
Page 79 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-26-2020
16:14:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-26-2020
16:14:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-26-2020
16:14:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019943
Page 80 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Aug-26-2020
16:15:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:1
Medical
History
Term:BILATERAL
TUBAL LIG
ATION
Start D
ate:UNK/UNK/2
017
Ongoin
g:NO
End Date:
UNK/UN
K/2017Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-26-2020
16:15:12
(UTC-06:00)
Central 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
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019944
Page 81 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-26-2020
16:15:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BILATERAL TUBA
L LIGATIONInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-26-2020
16:15:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-26-2020
16:15:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019945
Page 82 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Aug-26-2020
16:15:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-26-2020
16:15:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
151.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-26-2020
16:15:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019946
Page 83 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-26-2020
16:15:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
73.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-26-2020
16:15:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-26-2020
16:15:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
20.0Initial Entry
7.a
Date Location User Value Reason
Aug-26-2020
16:15:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.5Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019947
Page 84 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-26-2020
16:15:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-26-2020
16:15:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-26-2020
16:15:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019948
Page 85 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.a Temperature Location:
Date Location User Value Reason
Aug-26-2020
16:15:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019949
Page 86 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-26-2020
16:15:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-26-2020
16:15:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-26-2020
16:15:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019950
Page 87 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-26-2020
16:15:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-26-2020
16:15:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-26-2020
16:15:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019951
Page 88 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Aug-26-2020
16:15:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-26-2020
16:15:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-26-2020
16:15:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019952
Page 89 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-26-2020
16:16:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-26-2020
16:16:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
68478Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019953
Page 90 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020
16:16:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020
16:16:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020
08:47:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-26-2020
23:47:48
(UTC-06:00)ACV0PFEINFP6000  Query 1: Opene
d'Sample
Collected?' is
Yes, however
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1019954
Page 91 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Central Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-26-2020
16:16:27
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candi
date'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-26-2020
16:16:27
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collec
tion:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020
08:47:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP5D4
YInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019955
Page 92 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-27-2020
08:47:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP5D4YInitial Entry
5.b
Date Location User Value Reason
Aug-27-2020
08:47:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP5D4
ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-27-2020
08:47:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP5D4ZInitial Entry
5.c
Date Location User Value Reason
Aug-27-2020
08:47:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP5D5
0Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019956
Page 93 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.c Sample ID
Date Location User Value Reason
Aug-27-2020
08:47:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP5D50Initial Entry
5.d
Date Location User Value Reason
Sep-11-2020
14:14:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPR67
MInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-11-2020
14:14:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPR67MInitial Entry
5.e
Date Location User Value Reason
Sep-11-2020
14:14:37ACV0PFEINFP6000  Data Entry:
Sample ID BPR67Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1019957
Page 94 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-06:00)
Central Time (US
& Canada): N
5.e Sample ID
Date Location User Value Reason
Sep-11-2020
14:14:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPR67NInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019958
Page 95 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020
16:16:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020
16:16:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
14:36:25
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-26-2020
23:47:48
(UTC-06:00)ACV0PFEINFP6000  Query 1: Opene
d'Sample
Collected?' is
Yes, however
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1019959
Page 96 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Central Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-26-2020
16:16:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candi
date'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-26-2020
16:16:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collec
tion:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020
14:37:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPR67
PTranscription
Error
Aug-28-2020
14:36:25
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
Sample I
D:BPR67
PFInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019960
Page 97 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
14:37:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-28-2020
14:37:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPR67PTranscription
Error
Aug-28-2020
14:36:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Barcode is not
6 characters in
length. Please
review and
correct as
appropriate.
Aug-28-2020
14:36:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPR67PFInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019961
Page 98 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-26-2020
16:16:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-26-2020
16:16:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-26-2020
16:16:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019962
Page 99 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-26-2020
16:16:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020 14:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-26-2020
16:16:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-26-2020
16:16:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-26-2020
16:16:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019963
Page 100 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-26-2020
16:16:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-26-2020
16:16:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019964
Page 101 of 133
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-04-2020
00:32:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
ClosedResponse satisfies
query
Sep-03-2020
13:13:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
AnsweredTranscription Error
Sep-03-2020
13:13:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
NO - REA
CTOGENI
CITY E-D
IARY NO
T COLLE
CTED FO
R THIS S
UBJECTTranscription Error
Sep-03-2020
10:34:02
(UTC-06:00)
Central TimeACV0PFEINFP6000  Query 1:
OpenedeDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1019965
Page 102 of 133
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(US &
Canada)THIS SUBJECT is
'Yes' however VAX 1
eDiary records are
not available for the
subject. Please verify
and update. Else,
confirm in query
response
appropriately.
Aug-26-2020
16:17:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
YES - RE
ACTOGE
NICITY E
-DIARY C
OLLECT
ED FOR T
HIS SUBJ
ECTInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1019966
Page 103 of 133
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020
16:46:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019967
Page 104 of 133
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020
16:47:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020
16:47:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.5
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020
16:47:11
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019968
Page 105 of 133
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-18-2020
16:47:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020
16:47:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020
16:47:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019969
Page 106 of 133
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020
16:47:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020
16:47:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020
16:47:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019970
Page 107 of 133
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-18-2020
16:47:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020
16:47:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-18-2020
16:47:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019971
Page 108 of 133
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Sep-18-2020
16:47:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020
16:47:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020
16:47:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019972
Page 109 of 133
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020
17:55:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020
17:55:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020
16:51:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto
Query
Sep-18-2020
16:47:56
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Date of
Collection is
more than 1
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019973
Page 110 of 133
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Central Time (US
& Canada)day before
Dose Date on
the
Vaccination
form. Please
review and
update as
appropriate,
else clarify.
Sep-16-2020
17:55:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-16-2020
17:55:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-16-2020
17:55:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019974
Page 111 of 133
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-16-2020
17:55:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPR6PJInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020
17:55:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPR6PJInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019975
Page 112 of 133
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020
16:47:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020
16:47:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020
16:47:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019976
Page 113 of 133
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-18-2020
16:51:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-18-2020
16:51:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020 10:07Transcription
Error
Sep-18-2020
16:47:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Dose Date is
not equal to
Date of Visit
16/Sep/2020 of
the
corresponding
Visit. Please
review and
update as
appropriate.
Sep-18-2020
16:47:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020 10:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020
16:47:56
(UTC-06:00)
Central Time (USACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019977
Page 114 of 133
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
6. Body Side:
Date Location User Value Reason
Sep-18-2020
16:47:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020
16:47:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020
16:47:56
(UTC-06:00)
Central 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
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019978
Page 115 of 133
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-18-2020
16:47:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019979
Page 116 of 133
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-17-2020
03:58:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Saumitra
DubeyQuery 1: Closed Response
satisfies query
Oct-16-2020
08:03:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered EOT TAB
UPDATED
Oct-16-2020
05:07:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM: Patient
completed the
treatment
phase and
reached at
Visit 3. Kindly
consider to
update EOT
form with
matching V3
date or else
clarify. Thank
you.
Oct-14-2020
15:02:11
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1019980
Page 117 of 133
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019981
Page 118 of 133
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
15:02:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
15:02:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
15:30:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-15-2020
03:40:52
(UTC-06:00)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1019982
Page 119 of 133
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
15:02:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
15:02:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020
15:30:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BSHLP
DInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019983
Page 120 of 133
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-15-2020
15:30:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSHLPDInitial Entry
5.b
Date Location User Value Reason
Oct-15-2020
15:30:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BSHLP
FInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020
15:30:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSHLPFInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020
15:39:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRD94
DInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019984
Page 121 of 133
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.c Sample ID
Date Location User Value Reason
Oct-15-2020
15:39:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRD94DInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019985
Page 122 of 133
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-10-2021
15:54:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/10/2021Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019986
Page 123 of 133
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-10-2021
15:54:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-10-2021
15:54:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-10-2021
16:02:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-10-2021
15:54:55
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019987
Page 124 of 133
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-10-2021
15:54:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/10/2021Initial Entry
5.a
Date Location User Value Reason
Mar-10-2021
16:02:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BSHLX
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-10-2021
16:02:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSHLX9Initial Entry
5.b
Date Location User Value Reason
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019988
Page 125 of 133
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Mar-10-2021
16:03:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BSHLX
BInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-10-2021
16:03:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSHLXBInitial Entry
5.c
Date Location User Value Reason
Mar-10-2021
16:03:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BN5HG
6Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-10-2021
16:03:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN5HG6Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019989
Page 126 of 133
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-16-2020
08:03:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020
08:03:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020
08:03:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019990
Page 127 of 133
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-22-2021
14:20:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019991
Page 128 of 133
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-23-2021
16:44:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-23-2021
00:12:18
(UTC-06:00)
Central 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.
Feb-22-2021
14:20:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1019992
Page 129 of 133
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
complete this
date.
Feb-22-2021
14:20:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible and N
OT confirmed t
o have received
only placebo at
Vaccination 1/2Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1019993
Page 130 of 133
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-23-2021
16:44:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-23-2021
16:44:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019994
Page 131 of 133
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-16-2020
08:03:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-26-2020
16:16:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-26-2020
16:14:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-16-2020
08:03:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
Aug-26-2020
16:16:20ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019995
Page 132 of 133
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-06:00)
Central Time (US
& Canada)
Aug-26-2020
16:14:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1019996
Page 133 of 133
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020
16:34:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f52\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1019997