125742 S1 M5 CRF c4591001 1125 11251154

Document text

Page 1 of 395
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment
5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932491
Page 2 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/3/2020
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932492
Page 3 of 395
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11251154]
2.Birth Date: 1955
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932493
Page 4 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/3/2020
2.Erroneous Visit
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932494
Page 5 of 395
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932495
Page 6 of 395
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932496
Page 7 of 395
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: Feb/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSteoArthritis]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Angina pectoris]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932497
Page 8 of 395
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
2.Weight: [229.0]
3.Unit: LB
4.Height: [71.0]
5.Unit: in
6.Body Mass Index: [31.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932498
Page 9 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/3/2020
2.Randomization Number: [250931]
3.Randomization Group: [ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932499
Page 10 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/3/2020
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 [BJ38SL]
5.bSample ID [BJ38SM]
5.cSample ID [BP52VF]
5.dSample ID [BP52VG]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932500
Page 11 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/3/2020
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 [BKMKWX]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932501
Page 12 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/3/2020 09:39
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932502
Page 13 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932503
Page 14 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932504
Page 15 of 395
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932505
Page 16 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/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 [BP52XB]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932506
Page 17 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/22/2020 08:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932507
Page 18 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/23/2020
2.Erroneous Visit
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932508
Page 19 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/23/2020
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 [BPTMV5]
5.bSample ID [BPTMV6]
5.cSample ID [BJ39KF]
5.dSample ID [BJ39KG]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932509
Page 20 of 395
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932510
Page 21 of 395
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932511
Page 22 of 395
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932512
Page 23 of 395
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932513
Page 24 of 395
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932514
Page 25 of 395
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932515
Page 26 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932516
Page 27 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/4/2021
2.Date of First Symptom Started: Jan/20/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4 hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932517
Page 28 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
5.bSymptoms - Other Text: [fatigue]
5.cSymptoms - Other Text: [New or increased nasal discharge]
5.dSymptoms - Other Text: [New or increased nasal congestion]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932518
Page 29 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date of Collec
tionSpecimen T
ypeSpecimen Collection Lo
cationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932519
Page 30 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932520
Page 31 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Feb/27/2021
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 [AA03141]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932521
Page 32 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Telehealth visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932522
Page 33 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
Health Care Utilization Other
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932523
Page 34 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.Other Type of Practitioner
Specify:[Outpatient BAM infusion]
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
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932524
Page 35 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Jan/28/2021  NO
Discharge Date:
Feb/1/2021
 Repeating Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932525
Page 36 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Jan/28/2021
4.Ongoing? NO
Discharge Date:
Feb/1/2021
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932526
Page 37 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Treatment Ident
ifierCon Non-Drug Treatments Pre-
specifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932527
Page 38 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932528
Page 39 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:
[Covid-19]
Date of Diagnosis:
Jan/26/2021
3.Toxicity Grade: 3
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932529
Page 40 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category of Clinical Eve
nt:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Repeating Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932530
Page 41 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932531
Page 42 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Appli
cable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932532
Page 43 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932533
Page 44 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932534
Page 45 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932535
Page 46 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932536
Page 47 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Applicab
le Not Applicable  Not Appli
cable Not Appl
icable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932537
Page 48 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932538
Page 49 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932539
Page 50 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932540
Page 51 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932541
Page 52 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5 hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932542
Page 53 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932543
Page 54 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932544
Page 55 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932545
Page 56 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932546
Page 57 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932547
Page 58 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932548
Page 59 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932549
Page 60 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Not Appli
cable Repeating
Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932550
Page 61 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable 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 Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932551
Page 62 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932552
Page 63 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932553
Page 64 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/27/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/27/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932554
Page 65 of 395
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/27/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/27/2021
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 [BRHFYK]
5.bSample ID [BMPGV7]
5.cSample ID [BS5H6C]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932555
Page 66 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932556
Page 67 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Unplanned Assessments
1.Assessments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932557
Page 68 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/23/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932558
Page 69 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932559
Page 70 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932560
Page 71 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932561
Page 72 of 395
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Identif
ierAdverse Ev
entStart DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EV
ENT 1  Covid-19  Jan/20/2021 UNK:
UNK NO
End Date Time:
Feb/14/2021 UNK:UNK
 Repeating
Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932562
Page 73 of 395
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Covid-19]
4.Start Date Time: Jan/20/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/14/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).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
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
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932563
Page 74 of 395
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:
[infection]
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[2021123725]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932564
Page 75 of 395
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932565
Page 76 of 395
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932566
Page 77 of 395
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932567
Page 78 of 395
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932568
Page 79 of 395
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.1  IMMUNOGLOB
ULINS NO  bamlanivimab
 750  Repeating
Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932569
Page 80 of 395
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: IMMUNOGLOBULINS
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).[bamlanivimab]
5.Dose: [750]
6.Dose Unit: mg
7.Dose Frequency: ONCE
8.Route: INTRAVENOUS
9.Start Date: Jan/24/2021
10.Ongoing? NO
End Date:
Jan/24/2021
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932570
Page 81 of 395
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932571
Page 82 of 395
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932572
Page 83 of 395
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932573
Page 84 of 395
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932574
Page 85 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932575
Page 86 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932576
Page 87 of 395
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932577
Page 88 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932578
Page 89 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932579
Page 90 of 395
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932580
Page 91 of 395
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932581
Page 92 of 395
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932582
Page 93 of 395
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932583
Page 94 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932584
Page 95 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932585
Page 96 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932586
Page 97 of 395
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932587
Page 98 of 395
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932588
Page 99 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/27/2021
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932589
Page 100 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: Not Applicable Comments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932590
Page 101 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932591
Page 102 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Not Applicable
//Comments
2.Phase of Disposition: Not Applicable Comments
3.Status: Not Applicable Comments
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932592
Page 103 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932593
Page 104 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932594
Page 105 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/23/2020
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932595
Page 106 of 395
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932596
Page 107 of 395
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Charles Harper  Approved Mar-12-2021 00:09:56 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, 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.
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932597
Page 108 of 395
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormSep-03-2020 10:36:15 (UTC-06:00) Central
Time (US & Canada)patient met criteria for study
Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932598
Page 109 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormFeb-04-2021 11:50:47 (UTC-06:00) Central
Time (US & Canada)Awaiting medical records.
Not Done
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932599
Page 110 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Feb-04-2021 11:50:47 (UTC-06:00) Central
Time (US & Canada)Awaiting medical records.
Not Done
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932600
Page 111 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Feb-04-2021 11:50:47 (UTC-06:00) Central
Time (US & Canada)Awaiting medical records.
Not Done
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932601
Page 112 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Feb-04-2021 11:50:47 (UTC-06:00) Central
Time (US & Canada)Awaiting medical records.
Not Done
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932602
Page 113 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Feb-04-2021 11:50:47 (UTC-06:00) Central
Time (US & Canada) )Awaiting medical records.
Not Done
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932603
Page 114 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Feb-04-2021 11:50:47 (UTC-06:00) Central
Time (US & Canada)Awaiting medical records.
Not Done
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932604
Page 115 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Feb-04-2021 11:50:47 (UTC-06:00) Central
Time (US & Canada)Awaiting medical records.
Not Done
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932605
Page 116 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
7Feb-04-2021 11:50:47 (UTC-06:00) Central
Time (US & Canada)Awaiting medical records.
Not Done
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932606
Page 117 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
8Feb-04-2021 11:50:47 (UTC-06:00) Central
Time (US & Canada)Awaiting medical records.
Not Done
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932607
Page 118 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
9Feb-04-2021 11:50:47 (UTC-06:00) Central
Time (US & Canada)Awaiting medical records.
Not Done
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932608
Page 119 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-04-2021 14:15:05 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932609
Page 120 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-04-2021 14:15:05 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932610
Page 121 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Mar-04-2021 14:15:05 (UTC-06:00) Central
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932611
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932612
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932613
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
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Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932614
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Mar-04-2021 14:15:05 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932615
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-04-2021 14:16:15 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932616
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932617
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Mar-04-2021 14:16:15 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932618
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Mar-04-2021 14:16:15 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932619
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Mar-04-2021 14:16:15 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932620
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932621
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932622
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Mar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932623
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Mar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932624
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Mar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932625
Page 136 of 395
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932626
Page 137 of 395
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932627
Page 138 of 395
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932628
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932629
Page 140 of 395
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932630
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932631
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932632
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932633
Page 144 of 395
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932634
Page 145 of 395
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932635
Page 146 of 395
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932636
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932637
Page 148 of 395
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932638
Page 149 of 395
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932639
Page 150 of 395
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932640
Page 151 of 395
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932641
Page 152 of 395
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932642
Page 153 of 395
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932643
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932644
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932645
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932646
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932647
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932648
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932649
Page 160 of 395
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932650
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932651
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932652
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gMar-04-2021 14:16:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932653
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932654
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932655
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Mar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932656
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Mar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932657
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Mar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932658
Page 169 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932659
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932660
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932661
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932662
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932663
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932664
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932665
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932666
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932667
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932668
Page 179 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932669
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932670
Page 181 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932671
Page 182 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932672
Page 183 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932673
Page 184 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932674
Page 185 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932675
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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ItemDate User Comment
5.eMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932676
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932677
Page 188 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932678
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932679
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932680
Page 191 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932681
Page 192 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932682
Page 193 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932683
Page 194 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932684
Page 195 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932685
Page 196 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932686
Page 197 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.hMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932687
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.hMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932688
Page 199 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.hMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932689
Page 200 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.hMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932690
Page 201 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932691
Page 202 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932692
Page 203 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932693
Page 204 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932694
Page 205 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932695
Page 206 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932696
Page 207 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932697
Page 208 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jMar-04-2021 14:17:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932698
Page 209 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-04-2021 14:18:00 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932699
Page 210 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-04-2021 14:18:00 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932700
Page 211 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.aMar-04-2021 14:18:00 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932701
Page 212 of 395
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.aMar-04-2021 14:18:00 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932702
Page 213 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.aMar-04-2021 14:18:00 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932703
Page 214 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.aMar-04-2021 14:18:00 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932704
Page 215 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-04-2021 14:18:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932705
Page 216 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-04-2021 14:18:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932706
Page 217 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.aMar-04-2021 14:18:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932707
Page 218 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-04-2021 14:18:59 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932708
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-04-2021 14:18:59 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932709
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Mar-04-2021 14:18:59 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932710
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Mar-04-2021 14:18:59 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932711
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-04-2021 14:19:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932712
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-04-2021 14:19:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932713
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Mar-04-2021 14:19:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932714
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Mar-04-2021 14:19:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932715
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Mar-04-2021 14:19:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932716
Page 227 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Mar-04-2021 14:19:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932717
Page 228 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Mar-04-2021 14:19:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932718
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-04-2021 14:19:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932719
Page 230 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-04-2021 14:19:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932720
Page 231 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Mar-04-2021 14:19:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932721
Page 232 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Mar-04-2021 14:19:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932722
Page 233 of 395
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Mar-04-2021 14:19:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932723
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***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-01-2021 11:21:59 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932724
Page 235 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-01-2021 11:21:59 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932725
Page 236 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
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Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormFeb-27-2021 10:38:49 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932726
Page 237 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-01-2021 11:22:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932727
Page 238 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-01-2021 11:22:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932728
Page 239 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Mar-01-2021 11:22:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932729
Page 240 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Mar-01-2021 11:22:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932730
Page 241 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Mar-01-2021 11:22:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932731
Page 242 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-01-2021 11:22:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932732
Page 243 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-01-2021 11:22:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932733
Page 244 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Mar-01-2021 11:22:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932734
Page 245 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Mar-01-2021 11:22:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932735
Page 246 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Mar-01-2021 11:22:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932736
Page 247 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-01-2021 11:23:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932737
Page 248 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-01-2021 11:23:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932738
Page 249 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Mar-01-2021 11:23:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932739
Page 250 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Mar-01-2021 11:23:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932740
Page 251 of 395
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Mar-01-2021 11:23:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932741
Page 252 of 395
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Charles Harper  Approved Mar-12-2021 00:09:56 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, 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 Mar-10-2021 10:25:46 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles Harper  Approved Mar-09-2021 00:23:23 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, 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 Mar-04-2021 11:15:30 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932742
Page 253 of 395
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Charles Harper  Approved Mar-03-2021 23:15:27 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, 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 Mar-01-2021 11:21:59 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles Harper  Approved Feb-28-2021 19:11:26 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, 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 Feb-25-2021 11:50:59 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles Harper  Approved Feb-24-2021 08:15:51 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932743
Page 254 of 395
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Affidavit:
By my dated signature below, I, CharlesHarper, 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 Feb-15-2021 17:45:38 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles Harper  Approved Feb-09-2021 22:24:40 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, 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 Feb-04-2021 11:43:44 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles Harper  Approved Oct-28-2020 22:31:52 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932744
Page 255 of 395
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Affidavit:
By my dated signature below, I, CharlesHarper, 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.
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932745
Page 256 of 395
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-03-2020 10:33:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-03-2020 10:33:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0932746
Page 257 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-03-2020 10:33:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Sep/3/2020Initial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932747
Page 258 of 395
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-03-2020 10:31:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11251154Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-03-2020 10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1955Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-03-2020 10:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-03-2020 10:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-03-2020 10:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932748
Page 259 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-03-2020 10:35:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932749
Page 260 of 395
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-03-2020 10:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-03-2020 10:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-03-2020 10:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932750
Page 261 of 395
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Sep-03-2020 10:37:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Hypertensio
n
Start Date: Feb/UNK/2
000
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-03-2020 10:37:42
(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-03-2020 10:37:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-03-2020 10:37:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-03-2020 10:37:42
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0932751
Page 262 of 395
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
1.b
Date Location User Value Reason
Sep-03-2020 10:38:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Hypercholester
olemia
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932752
Page 263 of 395
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Line/MH Number:
Date Location User Value Reason
Sep-03-2020 10:38:19
(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-03-2020 10:38:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypercholesterolemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-03-2020 10:38:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-03-2020 10:38:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-04-2020 18:40:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numb
er:3
Medical History
Term:OSteoArthri
tis
Start Date: UNK/UNK/
2018
Ongoing: YESTranscription Error
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932753
Page 264 of 395
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-03-2020 10:38:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:Arthritis
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932754
Page 265 of 395
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.c Line/MH Number:
Date Location User Value Reason
Sep-03-2020 10:38:30
(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-08-2020 11:54:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-04-2020 18:40:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-04-2020 18:40:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OSteoArthritisTranscription Error
Sep-04-2020 12:28:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY -
Please specify if
ARTHRITIS is
OSTEO or
RHEUMATOID.
Update as
appropriate.
Sep-03-2020 10:38:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ArthritisInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-03-2020 10:38:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0932755
Page 266 of 395
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-03-2020 10:38:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Mar-04-2021 11:15:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Angina pecto
ris
Start Date: UNK/UNK/
2015
Ongoing: YESInitial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932756
Page 267 of 395
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.d Line/MH Number:
Date Location User Value Reason
Mar-04-2021 11:15:30
(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
Mar-04-2021 11:15:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Angina pectorisInitial Entry
1.d Start Date:
Date Location User Value Reason
Mar-04-2021 11:15:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Mar-04-2021 11:15:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932757
Page 268 of 395
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-03-2020 10:40:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-03-2020 10:40:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
229.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-03-2020 10:40:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-03-2020 10:40:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
71.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-03-2020 10:40:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0932758
Page 269 of 395
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-03-2020 10:40:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31.9Initial Entry
7.a
Date Location User Value Reason
Sep-03-2020 10:40:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.2
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-03-2020 10:40:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-03-2020 10:40:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-03-2020 10:40:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932759
Page 270 of 395
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-03-2020 10:40:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932760
Page 271 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-03-2020 10:44:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-03-2020 10:44:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
250931Initial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932761
Page 272 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 10:45:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 10:45:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 18:21:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 10:45:08
(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-03-2020 10:45:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932762
Page 273 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-03-2020 18:21:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BJ38SLInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 18:21:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BJ38SLInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020 18:22:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BJ38SMInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-03-2020 18:22:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BJ38SMInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020 18:22:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP52VFInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-03-2020 18:22:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP52VFInitial Entry
5.d
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0932763
Page 274 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Sep-03-2020 18:22:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP52VGInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-03-2020 18:22:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP52VGInitial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0932764
Page 275 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 10:45:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 10:45:18
(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-03-2020 18:21:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 10:45:18
(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-03-2020 10:45:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932765
Page 276 of 395
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-03-2020 18:21:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BKMKWXInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 18:21:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BKMKWXInitial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0932766
Page 277 of 395
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-03-2020 10:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 10:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020 10:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-03-2020 10:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020 09:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020 10:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932767
Page 278 of 395
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-03-2020 10:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-03-2020 10:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-03-2020 10:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-03-2020 10:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932768
Page 279 of 395
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-03-2020 10:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932769
Page 280 of 395
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-22-2020 09:44:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932770
Page 281 of 395
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020 09:45:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020 09:45:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 97.5
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020 09:45:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-22-2020 09:45:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-22-2020 09:45:21
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0932771
Page 282 of 395
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
2.a Temperature Location:
Date Location User Value Reason
Sep-22-2020 09:45:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d1e\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932772
Page 283 of 395
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251154 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Loca
…[truncated]