125742 S1 M5 CRF c4591001 1123 11231204

Document text

Page 1 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930810
Page 2 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/27/2020
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930811
Page 3 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11231204]
2.Birth Date: /1998
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:
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930812
Page 4 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930813
Page 5 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930814
Page 6 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930815
Page 7 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Attention deficit hyperactive disorder]
Start Date: Dec/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Anxiety]
Start Date: Dec/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Depression]
Start Date: Dec/UNK/2018
Ongoing: YES
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930816
Page 8 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [83.9]
3.Unit: kg
4.Height: [156.4]
5.Unit: cm
6.Body Mass Index: [34.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930817
Page 9 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/27/2020
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:
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930818
Page 10 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [71165]
3.Randomization Group: [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930819
Page 11 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BM567X]
5.bSample ID [BM567Y]
5.cSample ID [BM567Z]
5.dSample ID [BLZF4Y]
5.eSample ID [BLZF4Z]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930820
Page 12 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BM5680]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930821
Page 13 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/27/2020 16:09
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930822
Page 14 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930823
Page 15 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930824
Page 16 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930825
Page 17 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/15/2020
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:
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930826
Page 18 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
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 [BM56LP]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930827
Page 19 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/15/2020 16:19
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
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930828
Page 20 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930829
Page 21 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
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 [BM5P4V]
5.bSample ID [BM5P4W]
5.cSample ID [BM5P4X]
5.dSample ID [BMN2V9]
5.eSample ID [BMN2VB]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930830
Page 22 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/9/2021
2.Erroneous Visit
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930831
Page 23 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/9/2021
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 [BRKHGP]
5.bSample ID [BRKHGR]
5.cSample ID [BRKHGS]
5.dSample ID [BSM0PZ]
5.eSample ID [BSM0R0]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930832
Page 24 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930833
Page 25 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930834
Page 26 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930835
Page 27 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930836
Page 28 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930837
Page 29 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930838
Page 30 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930839
Page 31 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930840
Page 32 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930841
Page 33 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930842
Page 34 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930843
Page 35 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930844
Page 36 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930845
Page 37 of 155
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Unplanned Assessments
1.Assessments
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930846
Page 38 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930847
Page 39 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930848
Page 40 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930849
Page 41 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930850
Page 42 of 155
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  exposure durin
g pregnancy Oct/22/2020
UNK:UNK YES  Repeating
Pages
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930851
Page 43 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[exposure during pregnancy]
4.Start Date Time: Oct/22/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930852
Page 44 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is
due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930853
Page 45 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:UNKNOWN
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930854
Page 46 of 155
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930855
Page 47 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930856
Page 48 of 155
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930857
Page 49 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930858
Page 50 of 155
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930859
Page 51 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930860
Page 52 of 155
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930861
Page 53 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930862
Page 54 of 155
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930863
Page 55 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930864
Page 56 of 155
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930865
Page 57 of 155
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930866
Page 58 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930867
Page 59 of 155
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930868
Page 60 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930869
Page 61 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930870
Page 62 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930871
Page 63 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930872
Page 64 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930873
Page 65 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930874
Page 66 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/15/2021
2.Erroneous Visit
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930875
Page 67 of 155
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930876
Page 68 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/15/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930877
Page 69 of 155
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930878
Page 70 of 155
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930879
Page 71 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/13/2020
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930880
Page 72 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930881
Page 73 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930882
Page 74 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormAug-28-2020 08:49:15
(UTC-06:00) Central Time (US &
Canada)Not Applicable
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930883
Page 75 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Feb-24-2021 08:15:12 (UTC-06:00)
Central Time (US & Canada)N/A per crf guidelines V14
Not Applicable
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930884
Page 76 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-16-2021 13:11:55 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Brandon
Essink Approved Oct-21-2020 22:20:19 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BrandonEssink, 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.
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930885
Page 77 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-28-2020
08:48:48
(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-28-2020
08:48:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930886
Page 78 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020
08:48:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Con
sent Obtained
Aug/27/2020Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930887
Page 79 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020
08:48:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11231204Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020
08:48:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1998Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020
08:49:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930888
Page 80 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-28-2020
08:49:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020
08:49:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930889
Page 81 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020
08:49:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930890
Page 82 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-28-2020
08:49:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020
08:49:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020
08:49:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930891
Page 83 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020
08:50:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:1
Medical
History
Term:Attention de
ficit hyperac
tive disorder
Start Da
te:Dec/UNK/2
018
Ongoing
:YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020
08:50:00
(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
Aug-28-2020
08:50:00ACV0PFEINFP6000  Data Entry:
Attention deficit hyInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930892
Page 84 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-06:00)
Central Time (US
& Canada)peractive disorder
1.a Start Date:
Date Location User Value Reason
Aug-28-2020
08:50:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020
08:50:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-28-2020
08:50:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Anxiety
Start Date: Dec/UN
K/2018Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930893
Page 85 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Ongoing: YES
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930894
Page 86 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020
08:50:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
08:50:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
AnxietyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020
08:50:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020
08:50:12ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930895
Page 87 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-06:00)
Central Time (US
& Canada)
1.c
Date Location User Value Reason
Aug-28-2020
08:50:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Depressi
on
Start Date: Dec/UN
K/2018
Ongoing: YESInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930896
Page 88 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.c Line/MH Number:
Date Location User Value Reason
Aug-28-2020
08:50:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
08:50:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DepressionInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-28-2020
08:50:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-28-2020
08:50:24ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930897
Page 89 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930898
Page 90 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020
08:50:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020
08:50:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
83.9Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020
08:50:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930899
Page 91 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-28-2020
08:50:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
156.4Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020
08:50:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020
08:50:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
34.3Initial Entry
7.a
Date Location User Value Reason
Aug-28-2020
08:50:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperat
ure:36.7Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930900
Page 92 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Temperat
ure Unit:C
Temperat
ure Locat
ion::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020
08:50:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020
08:50:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020
08:50:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930901
Page 93 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020
08:50:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930902
Page 94 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-28-2020
08:51:35
(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-28-2020
08:51:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-28-2020
08:51:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930903
Page 95 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-28-2020
08:51:35
(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-28-2020
08:51:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-28-2020
08:51:35
(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:
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930904
Page 96 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-28-2020
08:51:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-28-2020
08:51:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropi
n Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-28-2020
08:51:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930905
Page 97 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020
08:51:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020
08:51:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
71165Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930906
Page 98 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020
11:20:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020
11:20:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
11:20:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-28-2020
11:20:43
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930907
Page 99 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-28-2020
11:20:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020
11:20:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BM567
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
11:20:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM567XInitial Entry
5.b
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930908
Page 100 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-28-2020
11:21:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BM567
YInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020
11:21:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM567YInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020
11:21:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BM567
ZInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930909
Page 101 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.c Sample ID
Date Location User Value Reason
Aug-28-2020
11:21:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM567ZInitial Entry
5.d
Date Location User Value Reason
Aug-28-2020
11:21:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BLZF4
YInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-28-2020
11:21:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLZF4YInitial Entry
5.e
Date Location User Value Reason
Aug-28-2020
11:21:29ACV0PFEINFP6000  Data Entry:
Sample I BLZF4Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930910
Page 102 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-06:00)
Central Time (US
& Canada)D: Z
5.e Sample ID
Date Location User Value Reason
Aug-28-2020
11:21:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLZF4ZInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930911
Page 103 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020
11:21:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020
11:21:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
11:21:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-28-2020
11:21:39
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930912
Page 104 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-28-2020
11:21:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020
11:21:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BM568
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
11:21:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM5680Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930913
Page 105 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020
08:52:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020
08:52:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020
08:52:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930914
Page 106 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-28-2020
08:52:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020 16:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020
08:52:07
(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-28-2020
08:52:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-28-2020
08:52:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930915
Page 107 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-28-2020
08:52:07
(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-28-2020
08:52:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930916
Page 108 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-28-2020
08:52:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTE
D FOR THIS SUB
JECTInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930917
Page 109 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-16-2020
09:15:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930918
Page 110 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020
09:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-16-2020
09:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperat
ure:36.8
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-16-2020
09:15:50
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930919
Page 111 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-16-2020
09:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-16-2020
09:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-16-2020
09:15:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930920
Page 112 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-16-2020
09:16:00
(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-16-2020
09:16:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-16-2020
09:16:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930921
Page 113 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-16-2020
09:16:00
(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-16-2020
09:16:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-16-2020
09:16:00
(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:
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930922
Page 114 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Sep-16-2020
09:16:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-16-2020
09:16:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropi
n Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-16-2020
09:16:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930923
Page 115 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020
07:35:05
(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
07:35:05
(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-16-2020
07:35:16
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-16-2020
07:35:05
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930924
Page 116 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Central Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-16-2020
07:35:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020
07:35:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BM56L
PInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020
07:35:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM56LPInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930925
Page 117 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-16-2020
09:16:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020
09:16:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020
09:16:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930926
Page 118 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-16-2020
09:16:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 
)Data Entry:
Sep/15/2020 16:19Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020
09:16:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-16-2020
09:16:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-16-2020
09:16:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930927
Page 119 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-16-2020
09:16:16
(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
Sep-16-2020
09:16:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930928
Page 120 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-13-2020
16:30:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930929
Page 121 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
09:02:18
(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
09:02:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020
09:02:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-14-2020
09:02:18
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930930
Page 122 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Central Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
09:02:18
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020
09:02:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BM5P4
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020
09:02:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM5P4VInitial Entry
5.b
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930931
Page 123 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Oct-14-2020
09:02:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BM5P4
WInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-14-2020
09:02:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM5P4WInitial Entry
5.c
Date Location User Value Reason
Oct-14-2020
09:02:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BM5P4
XInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930932
Page 124 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.c Sample ID
Date Location User Value Reason
Oct-14-2020
09:02:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM5P4XInitial Entry
5.d
Date Location User Value Reason
Oct-14-2020
09:02:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BMN2
V9Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-14-2020
09:02:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMN2V9Initial Entry
5.e
Date Location User Value Reason
Oct-14-2020
09:02:49ACV0PFEINFP6000  Data Entry:
Sample I BMN2Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930933
Page 125 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-06:00)
Central Time (US
& Canada)D: VB
5.e Sample ID
Date Location User Value Reason
Oct-14-2020
09:02:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMN2VBInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930934
Page 126 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-09-2021
15:24:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/9/2021Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930935
Page 127 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-10-2021
09:09:38
(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
09:09:38
(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
09:09:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-10-2021
09:09:38
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930936
Page 128 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-10-2021
09:09:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Mar/9/2021Initial Entry
5.a
Date Location User Value Reason
Mar-10-2021
09:09:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRKH
GPInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-10-2021
09:09:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRKHGPInitial Entry
5.b
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930937
Page 129 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Mar-10-2021
09:10:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRKH
GRInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-10-2021
09:10:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRKHGRInitial Entry
5.c
Date Location User Value Reason
Mar-10-2021
09:10:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRKH
GSInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930938
Page 130 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.c Sample ID
Date Location User Value Reason
Mar-10-2021
09:10:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRKHGSInitial Entry
5.d
Date Location User Value Reason
Mar-10-2021
09:10:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BSM0P
ZInitial Entry
5.d Sample ID
Date Location User Value Reason
Mar-10-2021
09:10:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSM0PZInitial Entry
5.e
Date Location User Value Reason
Mar-10-2021
09:10:49ACV0PFEINFP6000  Data Entry:
Sample I BSM0RInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930939
Page 131 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-06:00)
Central Time (US
& Canada)D: 0
5.e Sample ID
Date Location User Value Reason
Mar-10-2021
09:10:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSM0R0Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930940
Page 132 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-13-2020
16:30:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-13-2020
16:30:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-13-2020
16:30:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930941
Page 133 of 155
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Feb-23-2021
11:17:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930942
Page 134 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Feb-23-2021
11:17:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-23-2021
11:17:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-08-2021
01:19:29
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-04-2021
12:43:43
(UTC-06:00)ACV0PFEINFP6000  Query 1: Reissue
d:CandidatePending SDB
update
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930943
Page 135 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Central Time
(US & Canada)
Mar-04-2021
08:58:09
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edF/U report sent 04
Mar 2021 via fax.
Mar-03-2021
07:54:31
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissue
d:OpenedSAE RECON:
Term in Safety
database still
recorded as
pregnancy. Please
confirm if a follow
up SAE form was
submitted to
update term in
Safety database
Mar-01-2021
04:04:29
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissue
d:CandidatePending SDB
update
Feb-26-2021
16:30:07
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edWill submit f/u
SAE form with
updated term.
Feb-23-2021
23:43:42
(UTC-06:00)
Central TimeACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2021036854,
term in Safety
Database was
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930944
Page 136 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(US & Canada) reported as
'Pregnancy'. Per 3
Nov EDP guidance
(study
communication),
term should be
recorded as
Exposure during
pregnancy. Please
submit a follow up
SAE form to
update term in
SDB.
Feb-23-2021
11:17:42
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
exposure during p
regnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-24-2021
13:58:28
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-24-2021
08:14:44
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dTranscription
Error
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930945
Page 137 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Feb-24-2021
08:14:44
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020 UNK
:UNKTranscription
Error
Feb-23-2021
23:44:21
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2021036854
,onset date was
recorded as
22Oct2020 in
Safety database
however, recorded
as UNKOct2020
on AE CRF.
Please confirm
correct Onset
Date. If safety
update is required,
please submit a
follow-up SAE
form.
Feb-23-2021
11:17:42
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/UNK/2020 U
NK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-23-2021
11:17:42ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0930946
Page 138 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-06:00)
Central Time (US
& Canada)
6. Toxicity Grade:
Date Location User Value Reason
Feb-25-2021
03:40:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies
query
Feb-24-2021
08:15:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered NA per crf
guidelines
Feb-24-2021
08:15:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-24-2021
06:43:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
response for
"Toxicity
Grade" is
missing.
Kindly
review and
update.
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930947
Page 139 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User ValueReason
Mar-08-2021
01:20:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Clo
sedResponse satisfies query
Mar-05-2021
12:39:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Ans
weredplease clarify. changed to
non-serious
Mar-05-2021
11:15:45
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Rei
ssued:
Opene
dDM: Change is not noted.
Seriousness criteria is met there
is an abnormal pregnancy
outcome/protocol section
8.3.5.1. Please update
seriousness criteria accordingly.
Mar-04-2021
08:58:38
(UTC-06:00)
Central TimeACV0PFEINFP6000  auto query
(autoquery)Query
3: Ans
weredchanged per DM
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930948
Page 140 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(US &
Canada)
Mar-04-2021
08:58:38
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
NOchanged per DM
Mar-01-2021
04:05:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Rei
ssued:
Opene
dseriousness criteria is met there
is an abnormal pregnancy
outcome/protocol section
8.3.5.1. Please update
seriousness criteria accordingly.
Feb-26-2021
08:58:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Ans
weredPer sponsor Pregnancy should
be filed as an SAE. Please
advise.
Feb-24-2021
14:03:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Rei
ssued:
Opene
dSAE RECON1:
AER#2021036854,'EXPOSURE
DURING PREGNANCY' is
reported as non-serious in safety
database however marked as
serious in CRF. Please review
and update accordingly.
Feb-24-2021
08:15:52
(UTC-06:00)
Central TimeACV0PFEINFP6000  Query
3: Ans
weredSAE per pfizer protocol.
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930949
Page 141 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(US &
Canada)
Feb-23-2021
23:45:04
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Ope
nedSAE RECON:
AER#2021036854,'EXPOSURE
DURING PREGNANCY' event
was appropriately reported to
safety; however, seriousness
criteria is met there is an
abnormal pregnancy
outcome/protocol section
8.3.5.1. Please update
seriousness criteria accordingly.
Feb-23-2021
23:40:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Del
etedQuery can be addressed
internally
Feb-23-2021
11:18:38
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Clo
sedClose Auto Query
Feb-23-2021
11:18:38
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
YES
Is thi
s seri
ous eTranscription Error
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930950
Page 142 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
vent
asso
ciate
d wit
h co
ngen
ital a
nom
aly o
r birt
h def
ect?
NO
Did t
his s
eriou
s eve
nt re
sult i
n de
ath?
NO
Did t
his s
eriou
s eve
nt re
quire
or pr
olon
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930951
Page 143 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
g ho
spita
lizati
on?
NO
Did t
his s
eriou
s eve
nt re
sult i
n per
siste
nt or
signi
fican
t dis
abilit
y/inc
apac
ity?
NO
Is thi
s seri
ous e
vent
life t
hreat
enin
g?
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930952
Page 144 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
NO
Othe
r me
dical
ly im
porta
nt se
rious
even
t
YE
S
Feb-23-2021
11:17:42
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Ope
nedIs this adverse event serious?' is
reported 'Yes', but at least one
seriousness criteria is missing.
Please review and update as
appropriate.
Feb-23-2021
11:17:42
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Can
didateFor AE exposure during
pregnancy: Response to "Is the
adverse event serious?" is 'Yes'
but "Serious Adverse Event
Number" is blank.
Feb-23-2021
11:17:42
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000  Data
Entry
:
YES
OtheInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930953
Page 145 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Canada) r me
dical
ly im
porta
nt se
rious
even
t
YE
S
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-23-2021
11:17:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-23-2021
11:17:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHERInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930954
Page 146 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
If Other, specify:
unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-23-2021
11:17:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-23-2021
11:17:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-23-2021
11:17:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930955
Page 147 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Feb-24-2021
03:46:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-23-2021
11:18:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered per crf
guidelines this
is correct
Feb-23-2021
11:17:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE
exposure
during
pregnancy:
Response to
"What was the
outcome of
this adverse
event?" is
'Unknown' but
End
Date/Time is
provided or
"Is the adverse
event still
ongoing?" is
marked "Yes".
Feb-23-2021
11:17:42
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
UNKNOWNInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930956
Page 148 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Central Time (US
& Canada)
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-23-2021
11:17:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930957
Page 149 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-16-2021
13:12:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/15/2021Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930958
Page 150 of 155
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-16-2021
13:12:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willin
g to return for Vacc
ination 3
Participant is:
eligible and NO
T confirmed to
have received o
nly placebo at V
accination 1/2Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930959
Page 151 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-16-2021
13:11:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/15/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-16-2021
13:11:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBI
LITY FOR ADDIT
IONAL VACCINA
TIONInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930960
Page 152 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-13-2020
16:30:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-28-2020
08:51:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-28-2020
08:49:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-23-2021
23:54:48
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query 1: C
losedResponse satisfies query
Feb-23-2021 ACV0PFEINFP6000  Query 1: A AE added
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0930961
Page 153 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
11:48:20
(UTC-06:00)
Central Time
(US &
Canada)nswered
Feb-17-2021
19:06:17
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query 1: O
penedSAE
RECON:AER#2021146306
Non serious AE of
PREGNANCY was
reported in Safety database
but missing in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Oct-13-2020
16:30:39
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entr
y:
Oct/13/202
0Initial Entry
Aug-28-2020
08:51:48
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entr
y:
Aug/27/20
20Initial Entry
Aug-28-2020
08:49:25
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000  auto calc
(autocalc)Data Entr
y:
Aug/27/20
20Initial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930962
Page 154 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Canada)
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930963
Page 155 of 155
***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: 1123 Site Name: (1123) Meridian Clinical Research
Subject No: 11231204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020
22:20:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Brandon
EssinkData Entry:
Click Here to EnableInitial Entry
090177e196ae3f16\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0930964