125742 S1 M5 CRF c4591001 1093 10931141

Document text

Page 1 of 420
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020110
Page 2 of 420
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/22/2020
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020111
Page 3 of 420
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10931141]
2.Birth Date: 1957
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:
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020112
Page 4 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020113
Page 5 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020114
Page 6 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020115
Page 7 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYSTERECTOMY]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PENICILLIN ALLERGY]
Start Date: UNK/UNK/1980
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CERVICAL FUSION]
Start Date: UNK/UNK/1996
Ongoing: NO
End Date:
UNK/UNK/1996
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(b) (4)
FDA-CBER-2021-5683-1020116
Page 8 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[UTERINE CYSTS]
Start Date: UNK/UNK/1975
Ongoing: NO
End Date:
UNK/UNK/1977
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BILATERAL TUBAL LIGATION]
Start Date: UNK/UNK/1977
Ongoing: NO
End Date:
UNK/UNK/1977
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MENORRHAGIA]
Start Date: UNK/UNK/1968
Ongoing: NO
End Date:
UNK/UNK/2001
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HERNIATED DISCS]
Start Date: UNK/UNK/1994
Ongoing: NO
End Date:
UNK/UNK/1996
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(b) (4)
FDA-CBER-2021-5683-1020117
Page 9 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020118
Page 10 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
2.Weight: [266.2]
3.Unit: LB
4.Height: [68.0]
5.Unit: in
6.Body Mass Index: [40.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020119
Page 11 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/22/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
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(b) (4)
FDA-CBER-2021-5683-1020120
Page 12 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/22/2020
2.Randomization Number: [263817]
3.Randomization Group: [ ]
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(b) (4)
FDA-CBER-2021-5683-1020121
Page 13 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
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 [BP5DF9]
5.bSample ID [BPR6SJ]
5.cSample ID [BPR6SH]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020122
Page 14 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
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 [BPR6SD]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020123
Page 15 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/22/2020 14:31
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
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020124
Page 16 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020125
Page 17 of 420
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020126
Page 18 of 420
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Oct/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020127
Page 19 of 420
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/14/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020128
Page 20 of 420
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRD94B]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020129
Page 21 of 420
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/14/2020 14:00
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
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020130
Page 22 of 420
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020131
Page 23 of 420
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BJ88H4]
5.bSample ID [BSHLVP]
5.cSample ID [BSHLT0]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020132
Page 24 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/28/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020133
Page 25 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/28/2020
2.Date of First Symptom Started: Dec/25/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/31/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020134
Page 26 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [HEADACHE]
5.bSymptoms - Other Text: [FATIGUE]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020135
Page 27 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
 1.Dec/26/2
020 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SY
NDROME CORONAVIRUS
2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-1020136
Page 28 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/26/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [NALT UNKNOWN] Comments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020137
Page 29 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Dec/28/2020
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 [CV33957]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020138
Page 30 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[SUBJECT DID A SELF SWAB]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020139
Page 31 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020140
Page 32 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020141
Page 33 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Dec/26/2020  YES  Repeating Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020142
Page 34 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Dec/26/2020
4.Ongoing? YES
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020143
Page 35 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntTreatme
ntStart Da
teForm Instance
 1.Not Done  Not Done  Not Done
 Not Done
 Not Done
 Repeating
Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020144
Page 36 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020145
Page 37 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[UPPER RESPIRATORY INFECTION]
Date of Diagnosis:
Dec/26/2020
3.Toxicity Grade: 3
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020146
Page 38 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Repeating
Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020147
Page 39 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020148
Page 40 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done
 Not Done  Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020149
Page 41 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020150
Page 42 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020151
Page 43 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020152
Page 44 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020153
Page 45 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done
 Sponsor-Define
d IdentifierTest:Resul
t:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020154
Page 46 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020155
Page 47 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020156
Page 48 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020157
Page 49 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020158
Page 50 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020159
Page 51 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020160
Page 52 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020161
Page 53 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020162
Page 54 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Date: Vital Signs Details Form Instance
 1.Jan/19/2021 Record Identifier: Oxygen Saturation
Not Done  85.0 Repeating Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020163
Page 55 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/19/2021 Comments
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [85.0] Comments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020164
Page 56 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxyge
n)Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020165
Page 57 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020166
Page 58 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020167
Page 59 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication
identifier?Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
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).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020168
Page 60 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020169
Page 61 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020170
Page 62 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/11/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/11/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020171
Page 63 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/11/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/11/2021
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 [BSHLV7]
5.bSample ID [BSHLV8]
5.cSample ID [BJ88JJ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020172
Page 64 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020173
Page 65 of 420
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020174
Page 66 of 420
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020175
Page 67 of 420
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Unplanned Assessments
1.Assessments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020176
Page 68 of 420
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  URINARY TRACT INF
ECTION Dec/26/2020 U
NK:UNK NO
End Date Time:
Dec/28/2020 UNK:U
NK
 Repeating
Pages
 2.ADVERSE
EVENT 2  UPPER RESPIRATOR
Y INFECTION Dec/26/2020 U
NK:UNK NO
End Date Time:
Dec/28/2020 UNK:U
NK
 Repeating
Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020177
Page 69 of 420
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[URINARY TRACT INFECTION]
4.Start Date Time: Dec/26/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/28/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020178
Page 70 of 420
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.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:
[GYNOCOLOGY]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021107150]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020179
Page 71 of 420
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[UPPER RESPIRATORY INFECTION]
4.Start Date Time: Dec/26/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/28/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020180
Page 72 of 420
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.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:
[VIRAL]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021107150]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020181
Page 73 of 420
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020182
Page 74 of 420
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020183
Page 75 of 420
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.1  VACCINATION
S NO  INFLUENZA V
ACCINE Oct/4/2
020 Repeating
Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020184
Page 76 of 420
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[INFLUENZA VACCINE]
5.Date: Oct/4/2020
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020185
Page 77 of 420
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020186
Page 78 of 420
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020187
Page 79 of 420
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categor
yTreatment Identif
ierCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020188
Page 80 of 420
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020189
Page 81 of 420
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020190
Page 82 of 420
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020191
Page 83 of 420
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/11/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020192
Page 84 of 420
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020193
Page 85 of 420
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020194
Page 86 of 420
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020195
Page 87 of 420
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020196
Page 88 of 420
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020197
Page 89 of 420
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020198
Page 90 of 420
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020199
Page 91 of 420
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020200
Page 92 of 420
***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: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020201
Page 93 of 420
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020202
Page 94 of 420
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020203
Page 95 of 420
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020204
Page 96 of 420
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020205
Page 97 of 420
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/23/2021
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020206
Page 98 of 420
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020207
Page 99 of 420
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/23/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020208
Page 100 of 420
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020209
Page 101 of 420
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/23/2021
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 [BSHLWV]
5.bSample ID [BSHLWT]
5.cSample ID [BJ88GS]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020210
Page 102 of 420
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/23/2021
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 [BJ88GV]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020211
Page 103 of 420
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/23/2021 14:27
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020212
Page 104 of 420
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020213
Page 105 of 420
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020214
Page 106 of 420
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020215
Page 107 of 420
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020216
Page 108 of 420
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020217
Page 109 of 420
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020218
Page 110 of 420
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020219
Page 111 of 420
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020220
Page 112 of 420
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020221
Page 113 of 420
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020222
Page 114 of 420
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020223
Page 115 of 420
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/11/2020
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020224
Page 116 of 420
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020225
Page 117 of 420
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020226
Page 118 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormSep-22-2020 15:35:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020227
Page 119 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormDec-28-2020 17:11:17 (UTC-06:00) Central
Time (US & Canada)
FormDec-28-2020 17:10:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020228
Page 120 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Dec-28-2020 17:11:17 (UTC-06:00) Central
Time (US & Canada)
1Dec-28-2020 17:10:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-1020229
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
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Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Dec-28-2020 17:11:17 (UTC-06:00) Central
Time (US & Canada)
2Dec-28-2020 17:10:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020230
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Dec-28-2020 17:11:17 (UTC-06:00) Central
Time (US & Canada)
3Dec-28-2020 17:10:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020231
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Dec-28-2020 17:11:17 (UTC-06:00) Central
Time (US & Canada)
4Dec-28-2020 17:10:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020232
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5Dec-28-2020 17:11:17 (UTC-06:00) Central
Time (US & Canada)
5Dec-28-2020 17:10:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020233
Page 125 of 420
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Dec-28-2020 17:11:17 (UTC-06:00) Central
Time (US & Canada)
6Dec-28-2020 17:10:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020234
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
7Dec-28-2020 17:11:17 (UTC-06:00) Central
Time (US & Canada)
7Dec-28-2020 17:10:58 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020235
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
8Dec-28-2020 17:11:17 (UTC-06:00) Central
Time (US & Canada)
8Dec-28-2020 17:10:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020236
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
9Dec-28-2020 17:11:17 (UTC-06:00) Central
Time (US & Canada)
9Dec-28-2020 17:10:58 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020237
Page 129 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormDec-28-2020 17:13:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020238
Page 130 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Dec-28-2020 17:13:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020239
Page 131 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Dec-28-2020 17:13:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020240
Page 132 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Dec-28-2020 17:13:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020241
Page 133 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Dec-28-2020 17:13:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020242
Page 134 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5Dec-28-2020 17:13:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020243
Page 135 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Dec-28-2020 17:13:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020244
Page 136 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormFeb-16-2021 08:40:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormFeb-16-2021 08:40:08 (UTC-06:00) Central
Time (US & Canada)
FormDec-28-2020 17:14:02 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020245
Page 137 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Feb-16-2021 08:40:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1Feb-16-2021 08:40:08 (UTC-06:00) Central
Time (US & Canada)
1Dec-28-2020 17:14:02 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020246
Page 138 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Feb-16-2021 08:40:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
2Feb-16-2021 08:40:08 (UTC-06:00) Central
Time (US & Canada)
2Dec-28-2020 17:14:02 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-1020247
Page 139 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Feb-16-2021 08:40:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
3Feb-16-2021 08:40:08 (UTC-06:00) Central
Time (US & Canada)
3Dec-28-2020 17:14:02 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
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FDA-CBER-2021-5683-1020248
Page 140 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Feb-16-2021 08:40:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4Feb-16-2021 08:40:08 (UTC-06:00) Central
Time (US & Canada)
4Dec-28-2020 17:14:02 (UTC-06:00) Central
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(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
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(6)
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FDA-CBER-2021-5683-1020249
Page 141 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormDec-28-2020 17:14:17 (UTC-06:00) Central
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(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-1020250
Page 142 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Dec-28-2020 17:14:17 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-1020251
Page 143 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Dec-28-2020 17:14:17 (UTC-06:00) Central
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(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-1020252
Page 144 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Dec-28-2020 17:14:17 (UTC-06:00) Central
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(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-1020253
Page 145 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Dec-28-2020 17:14:17 (UTC-06:00) Central
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(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-1020254
Page 146 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.aDec-28-2020 17:14:17 (UTC-06:00) Central
Time (US & Canada)Not Done
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(6)
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FDA-CBER-2021-5683-1020255
Page 147 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.aDec-28-2020 17:14:17 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020256
Page 148 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.aDec-28-2020 17:14:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020257
Page 149 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.aDec-28-2020 17:14:17 (UTC-06:00) Central
Time (US & Canada)Not Done
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5.bDec-28-2020 17:14:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled
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Time (US & Canada)Not Done
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5.eDec-28-2020 17:14:17 (UTC-06:00) Central
Time (US & Canada)Not Done
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(6)
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Visit: POT_COVID_ILL 1 - Unscheduled
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5.eDec-28-2020 17:14:17 (UTC-06:00) Central
Time (US & Canada)Not Done
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(6)
(b) (4)
FDA-CBER-2021-5683-1020272
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.eDec-28-2020 17:14:17 (UTC-06:00) Central
Time (US & Canada)Not Done
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(6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
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5.eDec-28-2020 17:14:17 (UTC-06:00) Central
Time (US & Canada)Not Done
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(6)
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FDA-CBER-2021-5683-1020274
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Visit: POT_COVID_ILL 1 - Unscheduled
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Time (US & Canada)Not Done
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FDA-CBER-2021-5683-1020275
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
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Time (US & Canada)Not Done
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FDA-CBER-2021-5683-1020276
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
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Time (US & Canada)Not Done
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FDA-CBER-2021-5683-1020277
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled
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Visit: POT_COVID_ILL 1 - Unscheduled
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Visit: POT_COVID_ILL 1 - Unscheduled
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
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5.bDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
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(6)
(b) (4)
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Site No: 1093 Site Name: (1093) Meridian Clinical Research
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Time (US & Canada)Not Done
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(b) (4)
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Site No: 1093 Site Name: (1093) Meridian Clinical Research
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Site No: 1093 Site Name: (1093) Meridian Clinical Research
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Time (US & Canada)Not Done
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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Time (US & Canada)Not Done
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.cDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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Site No: 1093 Site Name: (1093) Meridian Clinical Research
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Time (US & Canada)Not Done
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.cDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.dDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
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(b) (4)
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.dDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4)
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.dDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.dDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.eDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
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(6)
(b) (4)
FDA-CBER-2021-5683-1020304
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.eDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
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(6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.eDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
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(6)
(b) (4)
FDA-CBER-2021-5683-1020306
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.eDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
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(6)
(b) (4)
FDA-CBER-2021-5683-1020307
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.fDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4)
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.fDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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(6)
(b) (4)
FDA-CBER-2021-5683-1020309
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.fDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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(6)
(b) (4)
FDA-CBER-2021-5683-1020310
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.fDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.gDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.gDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.gDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.gDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.hDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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ItemDate User Comment
5.hDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.hDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled
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Site No: 1093 Site Name: (1093) Meridian Clinical Research
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5.hDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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ItemDate User Comment
5.iDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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ItemDate User Comment
5.iDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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ItemDate User Comment
5.iDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020322
Page 214 of 420
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
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(6)
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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ItemDate User Comment
5.jDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
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(6)
(b) (4)
FDA-CBER-2021-5683-1020324
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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ItemDate User Comment
5.jDec-28-2020 17:14:30 (UTC-06:00) Central
Time (US & Canada)Not Done
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(6)
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FDA-CBER-2021-5683-1020325
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
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Time (US & Canada)Not Done
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FDA-CBER-2021-5683-1020326
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
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FDA-CBER-2021-5683-1020327
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***Confidential***
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Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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Time (US & Canada)Not Done
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FDA-CBER-2021-5683-1020328
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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FDA-CBER-2021-5683-1020329
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
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Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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ItemDate User Comment
2.aDec-28-2020 17:14:51 (UTC-06:00) Central
Time (US & Canada)Not Done
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FDA-CBER-2021-5683-1020330
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/28/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Done
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(b) (4), (b) 
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FDA-CBER-2021-5683-1020331
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
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Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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ItemDate User Comment
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Time (US & Canada)Not Done
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(b) (4), (b) 
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FDA-CBER-2021-5683-1020332
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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ItemDate User Comment
2.aDec-28-2020 17:14:51 (UTC-06:00) Central
Time (US & Canada)Not Done
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(6)
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FDA-CBER-2021-5683-1020333
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
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Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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ItemDate User Comment
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Time (US & Canada)
FormDec-28-2020 17:15:02 (UTC-06:00) Central
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(b) (4), (b) 
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FDA-CBER-2021-5683-1020334
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Visit: POT_COVID_ILL 1 - Unscheduled
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Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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Time (US & Canada)
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FDA-CBER-2021-5683-1020335
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
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Subject No: 10931141 Subject Initials: ---
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Time (US & Canada)
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(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-1020336
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
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Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
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ItemDate User Comment
FormFeb-16-2021 08:37:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormFeb-16-2021 08:37:23 (UTC-06:00) Central
Time (US & Canada)
FormDec-28-2020 17:15:14 (UTC-06:00) Central
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FDA-CBER-2021-5683-1020337
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
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Subject No: 10931141 Subject Initials: ---
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1Feb-16-2021 08:37:23 (UTC-06:00) Central
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FDA-CBER-2021-5683-1020338
Page 230 of 420
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
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Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
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FDA-CBER-2021-5683-1020339
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
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FDA-CBER-2021-5683-1020340
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***Confidential***
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FDA-CBER-2021-5683-1020341
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
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FDA-CBER-2021-5683-1020342
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
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FDA-CBER-2021-5683-1020344
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
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FDA-CBER-2021-5683-1020345
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***Confidential***
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***Confidential***
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***Confidential***
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
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***Confidential***
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
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Back to Form
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FDA-CBER-2021-5683-1020351
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
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Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
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FDA-CBER-2021-5683-1020352
Page 244 of 420
***Confidential***
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Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
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Subject No: 10931141 Subject Initials: ---
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FDA-CBER-2021-5683-1020353
Page 245 of 420
***Confidential***
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Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormFeb-24-2021 08:25:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020354
Page 246 of 420
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Feb-24-2021 08:25:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020355
Page 247 of 420
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Feb-24-2021 08:25:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020356
Page 248 of 420
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Feb-24-2021 08:25:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020357
Page 249 of 420
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Feb-24-2021 08:25:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020358
Page 250 of 420
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5Feb-24-2021 08:25:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020359
Page 251 of 420
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6.aFeb-24-2021 08:25:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020360
Page 252 of 420
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6.aFeb-24-2021 08:25:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020361
Page 253 of 420
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6.aFeb-24-2021 08:25:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1020362
Page 254 of 420
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Dec-28-2020 17:09:43 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Ensz  Approved Nov-16-2020 12:14:10 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidEnsz, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-12-2020 08:26:35 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Ensz  Approved Oct-29-2020 08:41:24 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020363
Page 255 of 420
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, DavidEnsz, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020364
Page 256 of 420
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-22-2020 15:34:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-22-2020 15:34:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020365
Page 257 of 420
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-22-2020 15:34:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Sep/22/2020Initial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020366
Page 258 of 420
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-22-2020 15:33:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10931141Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-22-2020 15:33:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1957Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-22-2020 15:34:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-22-2020 15:34:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO
(A) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-22-2020 15:34:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020367
Page 259 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-22-2020 15:34:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020368
Page 260 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-22-2020 15:35:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-22-2020 15:35:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-22-2020 15:35:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020369
Page 261 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Sep-22-2020 15:35:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:HYSTERECT
OMY
Start Date: UNK/UNK/20
01
Ongoing: NO
End Date:
UNK/UNK
/2001Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-22-2020 15:35:42
(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
Sep-28-2020 07:54:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response satisfies
query
Sep-25-2020 15:05:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered ENTRY BEING
ADDED
Sep-23-2020 12:18:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Opened CLINQUERY:
Please review the
medical condition
linked to this
procedure and
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1020370
Page 262 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
report as a separate
entry in the MH
listing, as
appropriate.
Sep-22-2020 15:35:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYSTERECTOMYInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-22-2020 15:35:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2001Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-22-2020 15:35:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2001Initial Entry
1.b
Date Location User Value Reason
Sep-22-2020 15:35:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:PENICILLIN
ALLERGY
Start Date: UNK/UNK/19
80
Ongoing: YESInitial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020371
Page 263 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.b Line/MH Number:
Date Location User Value Reason
Sep-22-2020 15:35:55
(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
Sep-22-2020 15:35:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PENICILLIN ALLERGYInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-22-2020 15:35:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-22-2020 15:35:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-22-2020 15:36:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histo
ry Term:CERVICAL F
USION
Start Date: UNK/UNK/19
96Initial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020372
Page 264 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Ongoing: NO
End Date:
UNK/UNK/
1996
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020373
Page 265 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.c Line/MH Number:
Date Location User Value Reason
Sep-22-2020 15:36:10
(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
Sep-28-2020 07:54:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response satisfies
query
Sep-25-2020 15:05:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered ENTRY BEING
ADDED
Sep-23-2020 12:18:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Opened CLINQUERY:
Please review the
medical condition
linked to this
procedure and
report as a separate
entry in the MH
listing, as
appropriate.
Sep-22-2020 15:36:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CERVICAL FUSIONInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-22-2020 15:36:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1996Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1020374
Page 266 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-22-2020 15:36:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1996Initial Entry
1.d
Date Location User Value Reason
Sep-25-2020 15:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histor
y Term:UTERINE CY
STS
Start Date: UNK/UNK/19
75
Ongoing: NO
End Date:
UNK/UNK
/1977Initial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020375
Page 267 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.d Line/MH Number:
Date Location User Value Reason
Sep-25-2020 15:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 15:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UTERINE CYSTSInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-25-2020 15:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1975Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-25-2020 15:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1977Initial Entry
1.e
Date Location User Value Reason
Sep-25-2020 15:06:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical Hi
story Term:BILATERAL TU
BAL LIGATION
Start Date: UNK/UNK/1977Initial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020376
Page 268 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Ongoing: NO
End Date:
UNK/UNK/19
77
1.e Line/MH Number:
Date Location User Value Reason
Sep-25-2020 15:06:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 15:06:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BILATERAL TUBAL LIGATI
ONInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-25-2020 15:06:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1977Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-25-2020 15:06:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1977Initial Entry
1.f
Date Location User Value Reason
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020377
Page 269 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-25-2020 15:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:MENORRHA
GIA
Start Date: UNK/UNK/19
68
Ongoing: NO
End Date:
UNK/UNK
/2001Initial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020378
Page 270 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.f Line/MH Number:
Date Location User Value Reason
Sep-25-2020 15:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 15:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MENORRHAGIAInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-25-2020 15:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1968Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-25-2020 15:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2001Initial Entry
1.g
Date Location User Value Reason
Sep-25-2020 15:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:HERNIATED
DISCS
Start Date: UNK/UNK/19
94Initial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020379
Page 271 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Ongoing: NO
End Date:
UNK/UNK/
1996
1.g Line/MH Number:
Date Location User Value Reason
Sep-25-2020 15:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 15:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HERNIATED DISCSInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-25-2020 15:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1994Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-25-2020 15:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1996Initial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020380
Page 272 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-22-2020 15:36:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to
be HIV POSITIVEInitial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020381
Page 273 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020 15:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-22-2020 15:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
266.2Initial Entry
3. Unit:
Date Location User Value Reason
Sep-22-2020 15:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-22-2020 15:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
68.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-22-2020 15:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020382
Page 274 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-22-2020 15:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
40.5Initial Entry
7.a
Date Location User Value Reason
Sep-22-2020 15:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 98.1
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-22-2020 15:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-22-2020 15:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-22-2020 15:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020383
Page 275 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-22-2020 15:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020384
Page 276 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-22-2020 15:36:36
(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-22-2020 15:36:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-22-2020 15:36:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-22-2020 15:36:36
(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-22-2020 15:36:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020385
Page 277 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Sep-22-2020 15:36:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifie
r:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-22-2020 15:36:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-22-2020 15:36:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-22-2020 15:36:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020386
Page 278 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-22-2020 15:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-22-2020 15:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
263817Initial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020387
Page 279 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020 15:37:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 15:37:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020 15:53:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-22-2020 15:37:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-22-2020 15:37:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020388
Page 280 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-22-2020 15:53:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP5DF9Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020 15:53:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP5DF9Initial Entry
5.b
Date Location User Value Reason
Sep-22-2020 15:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPR6SJInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-22-2020 15:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPR6SJInitial Entry
5.c
Date Location User Value Reason
Sep-22-2020 15:53:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPR6SHInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-22-2020 15:53:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPR6SHInitial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1020389
Page 281 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020 15:37:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 15:37:07
(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-22-2020 15:57:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-22-2020 15:37:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-22-2020 15:37:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020390
Page 282 of 420
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1093 Site Name: (1093) Meridian Clinical Research
Subject No: 10931141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-22-2020 15:57:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPR6SDInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020 15:57:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPR6SDInitial Entry
090177e196ae2f53\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020391
Page 283 of 420
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Ap
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