Document text
Page 1 of 382
***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: 11251014 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
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931859
Page 2 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/12/2020
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931860
Page 3 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11251014]
2.Birth Date: /1975
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0931861
Page 4 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/12/2020
2.Erroneous Visit
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931862
Page 5 of 382
***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: 11251014 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
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931863
Page 6 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931864
Page 7 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 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:[bilateral tubal ligation]
Start Date: Aug/19/2004
Ongoing: NO
End Date:
Aug/19/2004
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/2005
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperthyroidism]
Start Date: UNK/UNK/1994
Ongoing: NO
End Date:
UNK/UNK/1994
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931865
Page 8 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Radioactive Iodine Treatment on thyroid]
Start Date: UNK/UNK/1994
Ongoing: NO
End Date:
UNK/UNK/1994
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: UNK/UNK/2019
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[General discomfort]
Start Date: UNK/UNK/1995
Ongoing: YES
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931866
Page 9 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Aug/12/2020
2.Weight: [229.0]
3.Unit: LB
4.Height: [65.0]
5.Unit: in
6.Body Mass Index: [38.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931867
Page 10 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/12/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931868
Page 11 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/12/2020
2.Randomization Number: [47690]
3.Randomization Group: [ ]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931869
Page 12 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
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 [BP5B63]
5.bSample ID [BP5B64]
5.cSample ID [BP5BBZ]
5.dSample ID [BPR887]
5.eSample ID [BPR888]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931870
Page 13 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
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 [BP5B6R]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931871
Page 14 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/12/2020 17:46
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
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931872
Page 15 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931873
Page 16 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931874
Page 17 of 382
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931875
Page 18 of 382
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2 fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931876
Page 19 of 382
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931877
Page 20 of 382
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/2/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931878
Page 21 of 382
***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: 11251014 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/2/2020
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 [BP52P1]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931879
Page 22 of 382
***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: 11251014 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/2/2020 08:47
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
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931880
Page 23 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931881
Page 24 of 382
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931882
Page 25 of 382
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2 fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931883
Page 26 of 382
***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: 11251014 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/2/2020
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 [BPR8NH]
5.bSample ID [BM5HZG]
5.cSample ID [BM5HZH]
5.dSample ID [BJ38X9]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931884
Page 27 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: 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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931885
Page 28 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/10/2020
2.Date of First Symptom Started: Oct/30/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/17/2020
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? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931886
Page 29 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Fatigue]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931887
Page 30 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1.Nov/8/20
20 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931888
Page 31 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/8/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: POSITIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [NALT Unknown] Comments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931889
Page 32 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: 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: 11251014 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:
Nov/10/2020
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 [RW82948]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931890
Page 33 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: 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: 11251014 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:[self swab done]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931891
Page 34 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 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:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931892
Page 35 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931893
Page 36 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Treatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntTreatme
ntStart Dat
eForm Instance
1.Not Done Not Done Not Done
Not Done
Not Done
Repeating
Pages
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931894
Page 37 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 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 Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931895
Page 38 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 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:
Nov/8/2020
3.Toxicity Grade: 2
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931896
Page 39 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Grad
eForm Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931897
Page 40 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 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 Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931898
Page 41 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest:Result
:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931899
Page 42 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 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 Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931900
Page 43 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931901
Page 44 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931902
Page 45 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931903
Page 46 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1.Not Done Not Done Not Done Not Done Sponsor-Define
d IdentifierTest:Result
:
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one Repeating
Pages
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931904
Page 47 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 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 Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931905
Page 48 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931906
Page 49 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931907
Page 50 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931908
Page 51 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5 hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931909
Page 52 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931910
Page 53 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931911
Page 54 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 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 Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931912
Page 55 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Date: Vital Signs Details Form Instance
1.Nov/8/2020 Record Identifier: Oxygen Saturation
Not Done 86.0 Repeating Pages
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931913
Page 56 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/8/2020 Comments
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [86.0] Comments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931914
Page 57 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931915
Page 58 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 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 Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Done
[ ]Comments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931916
Page 59 of 382
***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: 11251014 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.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931917
Page 60 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 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 Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931918
Page 61 of 382
***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: 11251014 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 Done Not Done Not Done Not Done Repeating Pages
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931919
Page 62 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 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 Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931920
Page 63 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/09/2020Form: 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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931921
Page 64 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/09/2020Form: 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: 11251014 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:
Dec/9/2020
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 [BR7CJ0]
5.bSample ID [BR7CJ1]
5.cSample ID [BMPGMW]
5.dSample ID [BS5H16]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931922
Page 65 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931923
Page 66 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Unplanned Assessments
1.Assessments
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931924
Page 67 of 382
***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: 11251014 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/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931925
Page 68 of 382
***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: 11251014 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: [ ]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931926
Page 69 of 382
***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: 11251014 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:
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931927
Page 70 of 382
***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: 11251014 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 [ ]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931928
Page 71 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Pain in 3rd digit of R
ight hand Nov/26/2020 UN
K:UNK NO
End Date Time:
Nov/26/2020 UNK:U
NK
Repeating
Pages
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931929
Page 72 of 382
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 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)[Pain in 3rd digit of Right hand]
4.Start Date Time: Nov/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/26/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).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
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931930
Page 73 of 382
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 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:
[unknown]
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[ ]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931931
Page 74 of 382
***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: 11251014 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 Instanc
e
1. Repeating
Pages
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931932
Page 75 of 382
***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: 11251014 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[ ]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931933
Page 76 of 382
***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: 11251014 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
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931934
Page 77 of 382
***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: 11251014 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: //
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931935
Page 78 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931936
Page 79 of 382
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931937
Page 80 of 382
***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: 11251014 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
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931938
Page 81 of 382
***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: 11251014 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?
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931939
Page 82 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931940
Page 83 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931941
Page 84 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931942
Page 85 of 382
***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: 11251014 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:
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931943
Page 86 of 382
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931944
Page 87 of 382
***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: 11251014 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?
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931945
Page 88 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931946
Page 89 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931947
Page 90 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931948
Page 91 of 382
***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: 11251014 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
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931949
Page 92 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931950
Page 93 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931951
Page 94 of 382
***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: 11251014 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: [ ]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931952
Page 95 of 382
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931953
Page 96 of 382
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931954
Page 97 of 382
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931955
Page 98 of 382
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931956
Page 99 of 382
***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: 11251014 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/2/2020
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931957
Page 100 of 382
***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: 11251014 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
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931958
Page 101 of 382
***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: 11251014 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 Feb-24-2021 00:16:11 (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.
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0931959
Page 102 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormAug-13-2020 09:29:11 (UTC-06:00) Central
Time (US & Canada)patient met criteria to be enrolled in study.
Not Applicable
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931960
Page 103 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormDec-09-2020 09:17:53 (UTC-06:00) Central
Time (US & Canada)
FormNov-10-2020 15:48:21 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931961
Page 104 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Dec-09-2020 09:17:53 (UTC-06:00) Central
Time (US & Canada) )
1Nov-10-2020 15:48:21 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931962
Page 105 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Dec-09-2020 09:17:53 (UTC-06:00) Central
Time (US & Canada)
2Nov-10-2020 15:48:21 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931963
Page 106 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Dec-09-2020 09:17:53 (UTC-06:00) Central
Time (US & Canada)
3Nov-10-2020 15:48:21 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931964
Page 107 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Dec-09-2020 09:17:53 (UTC-06:00) Central
Time (US & Canada)
4Nov-10-2020 15:48:21 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931965
Page 108 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Dec-09-2020 09:17:53 (UTC-06:00) Central
Time (US & Canada)
5Nov-10-2020 15:48:21 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931966
Page 109 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Dec-09-2020 09:17:53 (UTC-06:00) Central
Time (US & Canada)
6Nov-10-2020 15:48:21 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931967
Page 110 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
7Dec-09-2020 09:17:53 (UTC-06:00) Central
Time (US & Canada)
7Nov-10-2020 15:48:21 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931968
Page 111 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
8Dec-09-2020 09:17:53 (UTC-06:00) Central
Time (US & Canada)
8Nov-10-2020 15:48:21 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931969
Page 112 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
9Dec-09-2020 09:17:53 (UTC-06:00) Central
Time (US & Canada)
9Nov-10-2020 15:48:21 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931970
Page 113 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormNov-10-2020 15:51:34 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931971
Page 114 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Nov-10-2020 15:51:34 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931972
Page 115 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Nov-10-2020 15:51:34 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931973
Page 116 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Nov-10-2020 15:51:34 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931974
Page 117 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Nov-10-2020 15:51:34 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931975
Page 118 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Nov-10-2020 15:51:34 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931976
Page 119 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Nov-10-2020 15:51:34 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931977
Page 120 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormDec-09-2020 15:11:47 (UTC-06:00) Central
Time (US & Canada)Not Done
FormDec-09-2020 15:11:30 (UTC-06:00) Central
Time (US & Canada)
FormDec-09-2020 09:11:58 (UTC-06:00) Central
Time (US & Canada)Not Done
FormDec-09-2020 09:11:25 (UTC-06:00) Central
Time (US & Canada)
FormNov-10-2020 15:52:59 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\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) (6)
(b) (4)
FDA-CBER-2021-5683-0931978
Page 121 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Dec-09-2020 15:11:47 (UTC-06:00) Central
Time (US & Canada)Not Done
1Dec-09-2020 15:11:30 (UTC-06:00) Central
Time (US & Canada)
1Dec-09-2020 09:11:58 (UTC-06:00) Central
Time (US & Canada)Not Done
1Dec-09-2020 09:11:25 (UTC-06:00) Central
Time (US & Canada)
1Nov-10-2020 15:52:59 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\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) (6)
(b) (4)
FDA-CBER-2021-5683-0931979
Page 122 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Dec-09-2020 15:11:47 (UTC-06:00) Central
Time (US & Canada)Not Done
2Dec-09-2020 15:11:30 (UTC-06:00) Central
Time (US & Canada)
2Dec-09-2020 09:11:58 (UTC-06:00) Central
Time (US & Canada)Not Done
2Dec-09-2020 09:11:25 (UTC-06:00) Central
Time (US & Canada)
2Nov-10-2020 15:52:59 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\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) (6)
(b) (4)
FDA-CBER-2021-5683-0931980
Page 123 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Dec-09-2020 15:11:47 (UTC-06:00) Central
Time (US & Canada)Not Done
3Dec-09-2020 15:11:30 (UTC-06:00) Central
Time (US & Canada)
3Dec-09-2020 09:11:58 (UTC-06:00) Central
Time (US & Canada)Not Done
3Dec-09-2020 09:11:25 (UTC-06:00) Central
Time (US & Canada)
3Nov-10-2020 15:52:59 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\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) (6)
(b) (4)
FDA-CBER-2021-5683-0931981
Page 124 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Dec-09-2020 15:11:47 (UTC-06:00) Central
Time (US & Canada)Not Done
4Dec-09-2020 15:11:30 (UTC-06:00) Central
Time (US & Canada)
4Dec-09-2020 09:11:58 (UTC-06:00) Central
Time (US & Canada)Not Done
4Dec-09-2020 09:11:25 (UTC-06:00) Central
Time (US & Canada)
4Nov-10-2020 15:52:59 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\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) (6)
(b) (4)
FDA-CBER-2021-5683-0931982
Page 125 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931983
Page 126 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Nov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931984
Page 127 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Nov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931985
Page 128 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Nov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada) )Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931986
Page 129 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Nov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931987
Page 130 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931988
Page 131 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931989
Page 132 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931990
Page 133 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931991
Page 134 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931992
Page 135 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931993
Page 136 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931994
Page 137 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931995
Page 138 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931996
Page 139 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931997
Page 140 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931998
Page 141 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0931999
Page 142 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932000
Page 143 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932001
Page 144 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932002
Page 145 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932003
Page 146 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932004
Page 147 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932005
Page 148 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932006
Page 149 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932007
Page 150 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932008
Page 151 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932009
Page 152 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932010
Page 153 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932011
Page 154 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932012
Page 155 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932013
Page 156 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932014
Page 157 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gNov-10-2020 15:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932015
Page 158 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932016
Page 159 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Nov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932017
Page 160 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Nov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932018
Page 161 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Nov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932019
Page 162 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Nov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932020
Page 163 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932021
Page 164 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932022
Page 165 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932023
Page 166 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932024
Page 167 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932025
Page 168 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932026
Page 169 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932027
Page 170 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932028
Page 171 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932029
Page 172 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932030
Page 173 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932031
Page 174 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932032
Page 175 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932033
Page 176 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932034
Page 177 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932035
Page 178 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932036
Page 179 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932037
Page 180 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932038
Page 181 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932039
Page 182 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932040
Page 183 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932041
Page 184 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932042
Page 185 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932043
Page 186 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932044
Page 187 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932045
Page 188 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932046
Page 189 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932047
Page 190 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932048
Page 191 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.hNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932049
Page 192 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.hNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932050
Page 193 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.hNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932051
Page 194 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.hNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932052
Page 195 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932053
Page 196 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932054
Page 197 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932055
Page 198 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932056
Page 199 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932057
Page 200 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932058
Page 201 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932059
Page 202 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jNov-10-2020 15:54:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932060
Page 203 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormNov-10-2020 15:54:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932061
Page 204 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Nov-10-2020 15:54:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932062
Page 205 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.aNov-10-2020 15:54:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932063
Page 206 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.aNov-10-2020 15:54:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932064
Page 207 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.aNov-10-2020 15:54:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932065
Page 208 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.aNov-10-2020 15:54:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932066
Page 209 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormDec-09-2020 15:12:17 (UTC-06:00) Central
Time (US & Canada)
FormNov-10-2020 15:55:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932067
Page 210 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Dec-09-2020 15:12:17 (UTC-06:00) Central
Time (US & Canada)
1Nov-10-2020 15:55:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932068
Page 211 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.aDec-09-2020 15:13:36 (UTC-06:00) Central
Time (US & Canada)o2 Saturation of 86% recorded at urgent care
visit
2.aDec-09-2020 15:12:17 (UTC-06:00) Central
Time (US & Canada)
2.aNov-10-2020 15:55:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\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-2021-5683-0932069
Page 212 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormNov-10-2020 15:56:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932070
Page 213 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Nov-10-2020 15:56:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932071
Page 214 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Nov-10-2020 15:56:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932072
Page 215 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Nov-10-2020 15:56:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932073
Page 216 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormNov-10-2020 15:56:50 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932074
Page 217 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Nov-10-2020 15:56:50 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932075
Page 218 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Nov-10-2020 15:56:50 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932076
Page 219 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Nov-10-2020 15:56:50 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932077
Page 220 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Nov-10-2020 15:56:50 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932078
Page 221 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Nov-10-2020 15:56:50 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932079
Page 222 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Nov-10-2020 15:56:50 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932080
Page 223 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormNov-10-2020 15:57:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932081
Page 224 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Nov-10-2020 15:57:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932082
Page 225 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Nov-10-2020 15:57:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932083
Page 226 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Nov-10-2020 15:57:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932084
Page 227 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/10/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Nov-10-2020 15:57:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932085
Page 228 of 382
***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: 11251014 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 Feb-24-2021 00:16:11 (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-23-2021 10:25:45 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles Harper Approved Jan-09-2021 11:14:31 (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 Jan-06-2021 09:19:28 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932086
Page 229 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Charles Harper Approved Dec-23-2020 09:02:17 (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 Dec-15-2020 15:54:12 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles Harper Approved Dec-14-2020 22:32:44 (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 Dec-09-2020 09:05:44 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles Harper Approved Nov-16-2020 23:13:18 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932087
Page 230 of 382
***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: 11251014 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 Nov-16-2020 13:52:53 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles Harper Approved Nov-12-2020 07:43:37 (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 Nov-10-2020 15:44:49 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles Harper Approved Oct-09-2020 16:20:26 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932088
Page 231 of 382
***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: 11251014 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 Oct-02-2020 10:12:16 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles Harper Approved Sep-14-2020 20:30:01 (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.
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932089
Page 232 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-13-2020 09:27:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-13-2020 09:27:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932090
Page 233 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-13-2020 09:28:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/12/2020Initial Entry
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932091
Page 234 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-13-2020 09:27:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11251014Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-13-2020 09:27:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1975Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-13-2020 09:28:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-13-2020 09:28:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-13-2020 09:28:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d21\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-2021-5683-0932092
Page 235 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-13-2020 09:28:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932093
Page 236 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-13-2020 09:29:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-13-2020 09:29:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-13-2020 09:29:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932094
Page 237 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Aug-14-2020 12:31:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:bilateral tubal
ligation
Start Date: Aug/19/2004
Ongoing: NO
End Date:
Aug/19/20
04Transcription Error
Aug-13-2020 09:31:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:bilateral tubular
occlusion
Start Date: Aug/19/2004
Ongoing: NO
End Date:
Aug/19/200
4Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:31:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Query 1: Cl Discrepancy has
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932095
Page 238 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
14:01:03
(UTC-06:00)
Central Time
(US & Canada)Oracle osed been closed.
Aug-14-2020
12:31:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: A
nsweredTranscription
Error
Aug-14-2020
12:31:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
bilateral tu
bal ligationTranscription
Error
Aug-13-2020
11:08:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: O
penedClarify
BILATERAL
TUBULAR
OCCLUSION
as
follows...Term
is unclear. Are
you reporting
BILATERAL
FALLOPIAN
TUBE
OCCLUSION?
Or TUBAL
LIGATION? Or
other? Please
update the
verbatim term
to clarify. Thank
you.
Aug-13-2020
09:31:37
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
bilateral tu
bular occlu
sionInitial Entry
1.a Start Date:
Date Location User Value Reason
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0932096
Page 239 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-13-2020 09:31:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2004Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-13-2020 09:31:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/19/2004Initial Entry
1.b
Date Location User Value Reason
Aug-13-2020 09:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Seasonal Alle
rgies
Start Date: UNK/UNK/2
005
Ongoing: YESInitial Entry
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932097
Page 240 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Seasonal AllergiesInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-13-2020 09:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-13-2020 09:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-13-2020 09:32:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical Histor
y Term:Hyperthyroidis
m
Start Date: UNK/UNK/19
94Initial Entry
090177e196ae3d21\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-2021-5683-0932098
Page 241 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Ongoing: NO
End Date:
UNK/UNK
/1994
1.c Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:32:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:32:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HyperthyroidismInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-13-2020 09:32:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1994Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-13-2020 09:32:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1994Initial Entry
1.d
Date Location User Value Reason
Aug-14-2020 08:05:30
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Line/MH 4Changed
Information
090177e196ae3d21\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)
FDA-CBER-2021-5683-0932099
Page 242 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada) Number:
Medical H
istory Ter
m:Radioactive Iodine
Treatment on thyro
id
Start Date
:UNK/UNK/1994
Ongoing: NO
End Date:
UNK/UNK/199
4
Aug-13-2020 09:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:4
Medical
History
Term:Radioactive Iodine T
reatment on thyroid f
or hyperthyroidism
Start D
ate:UNK/UNK/1994
Ongoin
g:NO
End Date:
UNK/UNK/1994Initial Entry
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932100
Page 243 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.d Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:33:51
(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 ValueReason
Aug-14-2020
09:51:24
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has been
closed.
Aug-14-2020
08:05:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dChanged Information
Aug-14-2020
08:05:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Radio
active
Iodine
Treat
ment
on thy
roidChanged Information
Aug-13-2020
23:37:46
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedMultiple concepts in the
term RADIOACTIVE
IODINE TREATMENT
ON THYROID FOR
HYPERTHYROIDISM.
Split the term into
RADIOACTIVE
IODINE TREATMENT
ON THYROID and
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0932101
Page 244 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
HYPERTHYROIDISM
and submit separately.
Thank you.
Aug-13-2020
09:33:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Radio
active
Iodine
Treat
ment
on thy
roid f
or hyp
erthyr
oidis
mInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-13-2020 09:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1994Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-13-2020 09:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1994Initial Entry
1.e
Date Location User Value Reason
Aug-13-2020 09:34:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5Initial Entry
090177e196ae3d21\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-2021-5683-0932102
Page 245 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Medical History
Term:Anxiety
Start Date: UNK/UNK/
2019
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:34:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:34:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AnxietyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-13-2020 09:34:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-13-2020 09:34:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-13-2020 09:34:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6Initial Entry
090177e196ae3d21\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-2021-5683-0932103
Page 246 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Medical History
Term:General disco
mfort
Start Date: UNK/UNK/1
995
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:34:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:34:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
General discomfortInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-13-2020 09:34:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-13-2020 09:34:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d21\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-2021-5683-0932104
Page 247 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Aug-13-2020 09:35:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-13-2020 09:35:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
229.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-13-2020 09:35:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-13-2020 09:35:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
65.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-13-2020 09:35:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3d21\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) (6)
(b) (4)
FDA-CBER-2021-5683-0932105
Page 248 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-13-2020 09:35:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
38.1Initial Entry
7.a
Date Location User Value Reason
Aug-13-2020 09:35:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 98.9
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-13-2020 09:35:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-13-2020 09:35:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-13-2020 09:35:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3d21\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-2021-5683-0932106
Page 249 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-13-2020 09:35:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932107
Page 250 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-13-2020 09:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-13-2020 09:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-13-2020 09:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-13-2020 09:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-13-2020 09:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932108
Page 251 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-13-2020 09:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-13-2020 09:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-13-2020 09:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Aug-13-2020 09:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932109
Page 252 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-13-2020 09:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-13-2020 09:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
47690Initial Entry
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932110
Page 253 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020 09:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020 09:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020 10:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-14-2020 03:57:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-13-2020 09:37:15
(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.
Aug-13-2020 09:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932111
Page 254 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug/12/2020
5.a
Date Location User Value Reason
Aug-14-2020 10:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5B63Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-14-2020 10:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5B63Initial Entry
5.b
Date Location User Value Reason
Aug-14-2020 10:00:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5B64Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-14-2020 10:00:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5B64Initial Entry
5.c
Date Location User Value Reason
Aug-18-2020 11:40:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5BBZTranscription Error
Aug-14-2020 10:00:42
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BP5B65Initial Entry
090177e196ae3d21\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) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0932112
Page 255 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
5.c Sample ID
Date Location User Value Reason
Aug-18-2020 11:40:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5BBZTranscription Error
Aug-14-2020 10:00:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5B65Initial Entry
5.d
Date Location User Value Reason
Aug-18-2020 11:41:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR887Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-18-2020 11:41:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR887Initial Entry
5.e
Date Location User Value Reason
Aug-18-2020 11:41:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR888Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-18-2020 11:41:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR888Initial Entry
090177e196ae3d21\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) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932113
Page 256 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020 09:37:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020 09:37:32
(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-15-2020 02:44:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Sep-14-2020 11:24:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Sep-14-2020 11:24:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/12/2020Transcription Error
Sep-13-2020 01:20:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM 1: Thanks for
the response, form
is unfreeze now,
please review and
update.
Sep-12-2020 08:52:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Please unlock to
correct date
090177e196ae3d21\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-2021-5683-0932114
Page 257 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-10-2020 11:29:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened DM QUERY:
Sample Collected
is 11AUG2020
which is prior to
the consent date of
12AUG2020.
Please review and
update as necessary
or clarify.
Aug-14-2020 09:16:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-14-2020 03:58:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-13-2020 09:37:32
(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.
Aug-13-2020 09:37:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020 09:16:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5B6RInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d21\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-2021-5683-0932115
Page 258 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-14-2020 09:16:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5B6RInitial Entry
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932116
Page 259 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-13-2020 09:37:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-13-2020 09:37:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-13-2020 09:37:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-13-2020 09:37:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020 17:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-13-2020 09:37:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932117
Page 260 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-13-2020 09:37:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-13-2020 09:37:51
(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
Aug-13-2020 09:37:51
(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
Aug-13-2020 09:37:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932118
Page 261 of 382
***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: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-13-2020 09:39:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-
DIARY COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932119
Page 262 of 382
***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: 11251014 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-02-2020 09:39:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
090177e196ae3d21\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932120
Page 263 of 382
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251014 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 09:41:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-02-2020 09:41:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-02-2020 09:41:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 09:41:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-02-2020 09:41:38 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d21\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-2021-5683-0932121
Page 264 of 382
***Confidential***
Header Text: c4591001
Vis
…[truncated]