Document text
Page 1 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 version30 JUN 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983279
Page 2 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jul/31/2020
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983280
Page 3 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11401009]
2.Birth Date: /1979
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0983281
Page 4 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/31/2020
2.Erroneous Visit
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983282
Page 5 of 506
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive,
65 and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for
inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes
compliance with the requirements and restrictions listed in the ICD and in
this protocol
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN04A00
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983283
Page 6 of 506
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or
active suicidal ideation/behavior/lab abnormality that may increase the risk
of study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C
virus (HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study
intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX04A00
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983284
Page 7 of 506
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected
immunodeficiency, as determined by history and/or laboratory/physical
examination
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that
would, in the opinion of the investigator, contraindicate intramuscular
injection
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX11A00
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents
or systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX13A01
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983285
Page 8 of 506
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before
study intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX14A01
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days
prior to study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention
containing lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX16A01
2 mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of
the study, site staff otherwise supervised by the investigator, and their
respective family members
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX21A01
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983286
Page 9 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathJul/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983287
Page 10 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: Nov/1/1985
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gout]
Start Date: Sep/1/2013
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to cats]
Start Date: Aug/1/1988
Ongoing: YES
1.dLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: Jun/1/1997
Ongoing: NO
End Date:
Jun/1/1997
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983288
Page 11 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to bees]
Start Date: Aug/1/1988
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to shrimp]
Start Date: Aug/1/1988
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergy to penicillin]
Start Date: Aug/1/1988
Ongoing: YES
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983289
Page 12 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Jul/31/2020
2.Weight: [224.6]
3.Unit: LB
4.Height: [72.36]
5.Unit: in
6.Body Mass Index: [30.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983290
Page 13 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Jul/31/2020
2.Randomization Number: [40104]
3.Randomization Group: [ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983291
Page 14 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jul/31/2020
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 [BPG57C]
5.bSample ID [BPG57D]
5.cSample ID [BNB416]
5.dSample ID [BNB417]
5.eSample ID [BNB418]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983292
Page 15 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jul/31/2020
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 [BNB419]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983293
Page 16 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: Jul/31/2020 09:28
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
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983294
Page 17 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983295
Page 18 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/20/2020
2.Erroneous Visit
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983296
Page 19 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983297
Page 20 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983298
Page 21 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983299
Page 22 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
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 [BPYZLR]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983300
Page 23 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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/20/2020 14:57
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
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983301
Page 24 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983302
Page 25 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983303
Page 26 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983304
Page 27 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/17/2020
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 [BPYZ56]
5.bSample ID [BNWXLW]
5.cSample ID [BNWXLX]
5.dSample ID [BNWXLY]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983305
Page 28 of 506
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/11/2021
2.Erroneous Visit
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983306
Page 29 of 506
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/11/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRFJD8]
5.bSample ID [BSGRDP]
5.cSample ID [BSGRDR]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983307
Page 30 of 506
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983308
Page 31 of 506
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983309
Page 32 of 506
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983310
Page 33 of 506
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983311
Page 34 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/21/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983312
Page 35 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Aug/21/2020
2.Date of First Symptom Started: Aug/21/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Aug/24/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983313
Page 36 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983314
Page 37 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1.Aug/21/2
020 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983315
Page 38 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Aug/21/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [Rheonix COVID-19 MDx assay] Comments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983316
Page 39 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Aug/21/2020
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 [RW86831]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983317
Page 40 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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:[TELEMED CONDUCTED VIA PHONE]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983318
Page 41 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983319
Page 42 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983320
Page 43 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Treatment Iden
tifierCon Non-Drug Treatments Pre
-specifiedTreatment Treatment Start DateForm Instanc
e
1.Not Applicable Not Applicable Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983321
Page 44 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983322
Page 45 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?NO
3.Toxicity Grade: 1
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983323
Page 46 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applicabl
e Repeating Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983324
Page 47 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983325
Page 48 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instan
ce
1.Not Applicabl
e Not Appli
cable Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983326
Page 49 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983327
Page 50 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983328
Page 51 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983329
Page 52 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983330
Page 53 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category fo
r Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.Not Applicab
le Not Applicable Not Appli
cable Not Appl
icable Sponsor-Defin
ed IdentifierTest: Result:
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983331
Page 54 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983332
Page 55 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983333
Page 56 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983334
Page 57 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983335
Page 58 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5 hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983336
Page 59 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983337
Page 60 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983338
Page 61 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983339
Page 62 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983340
Page 63 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983341
Page 64 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983342
Page 65 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983343
Page 66 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart Dat
eForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicabl
e Not Appli
cable Repeating
Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983344
Page 67 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983345
Page 68 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983346
Page 69 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983347
Page 70 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/13/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983348
Page 71 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/13/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYZCD]
5.bSample ID [BPG5X4]
5.cSample ID [BPG5XL]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983349
Page 72 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983350
Page 73 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983351
Page 74 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Sep/17/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983352
Page 75 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983353
Page 76 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983354
Page 77 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983355
Page 78 of 506
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
1. ADVERSE
EVENT 1 Injection Site Swelli
ng Jul/31/2020
12:00 NO
End Date Time:
Aug/1/2020 08:00
Repeating
Pages
2. ADVERSE
EVENT 2 Injection Site Pain Jul/31/2020
12:00 NO
End Date Time:
Aug/1/2020 08:00
Repeating
Pages
3. DELETED ADVERSE
EVENT 3 Fever Aug/21/202
0 07:00 YES Repeating
Pages
4. DELETED ADVERSE
EVENT 4 Bee Sting Aug/28/202
0 14:00 NO
End Date Time:
Aug/28/2020 14:00
Repeating
Pages
5. ADVERSE
EVENT 5 Anaphylaxis Status
Post Bee Sting Aug/28/202
0 14:00 NO
End Date Time:
Aug/28/2020 20:00
Repeating
Pages
6. ADVERSE
EVENT 6 Cellulitis Status Post
Bee Sting Aug/30/202
0 08:00 NO
End Date Time:
Sep/9/2020 08:00
Repeating
Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983356
Page 79 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[Injection Site Swelling]
4.Start Date Time: Jul/31/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/1/2020 08:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983357
Page 80 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
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[ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983358
Page 81 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Injection Site Pain]
4.Start Date Time: Jul/31/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/1/2020 08:00
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
9.Is this event related to study
treatment:RELATED
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983359
Page 82 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
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[ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983360
Page 83 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fever]
4.Start Date Time: Aug/21/2020 07:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983361
Page 84 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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?:NOT RECOVERED/NOT 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[ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983362
Page 85 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Bee Sting ]
4.Start Date Time: Aug/28/2020 14:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/28/2020 14:00
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983363
Page 86 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Subject has allergy to bee venom ]
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[ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983364
Page 87 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Anaphylaxis Status Post Bee Sting]
4.Start Date Time: Aug/28/2020 14:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/28/2020 20:00
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983365
Page 88 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Subject with history of allergy to bee venom]
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[2020363634]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983366
Page 89 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Cellulitis Status Post Bee Sting]
4.Start Date Time: Aug/30/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 08:00
6.Toxicity Grade: 2
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
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983367
Page 90 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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:
[Subject with history of allergy to bee venom]
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[ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983368
Page 91 of 506
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryMedication
ErrorStart DateIs the medication error St
ill OngoingStudy Medication Erro
rs ActionForm Instanc
e
1.Not Applic
able Not Applicab
le Not Applic
able Not Applicable Not Applicable Repeating
Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983369
Page 92 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of
Medication Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still
ongoing?Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication
given?Not Applicable Comments
7.Was a Non-Drug Treatment
given?Not Applicable Comments
8.Did the Medication Error cause
the subject to be discontinued
from the study?Not Applicable Comments
9.Was this medication error
associated with any adverse
events?Not Applicable Comments
10.Serious Adverse Event Number:
For Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983370
Page 93 of 506
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart Dat
eForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicabl
e Not Appli
cable Repeating
Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983371
Page 94 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983372
Page 95 of 506
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicat
ions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
1. DELETED 1 CORTICOSTE
ROIDS NO methylpredn
isolone 125 Repeating
Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983373
Page 96 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1] Comments
2.Category: CORTICOSTEROIDS Comments
3.Concomitant Medications
Pre-specified:NO 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).[methylprednisolone ] Comments
5.Dose: [125] Comments
6.Dose Unit: mg Comments
7.Dose Frequency: ONCE Comments
8.Route: INTRAVENOUS Comments
9.Start Date: Aug/28/2020 Comments
10.Ongoing? NO
End Date:
Aug/28/2020Comments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983374
Page 97 of 506
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryTreatment Iden
tifierCon Non-Drug Treatments Pre
-specifiedTreatment Start DateForm Instanc
e
1.Not Applica
ble Not Applicable Not Applicable Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983375
Page 98 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983376
Page 99 of 506
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
1.Not Applicable Not Applicable Repeating Pages
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983377
Page 100 of 506
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983378
Page 101 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983379
Page 102 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983380
Page 103 of 506
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983381
Page 104 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983382
Page 105 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983383
Page 106 of 506
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983384
Page 107 of 506
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983385
Page 108 of 506
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983386
Page 109 of 506
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983387
Page 110 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983388
Page 111 of 506
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination
1/2
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983389
Page 112 of 506
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/18/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983390
Page 113 of 506
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983391
Page 114 of 506
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983392
Page 115 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/17/2020
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983393
Page 116 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983394
Page 117 of 506
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Stephen
Thomas Approved Mar-11-2021 11:37:53 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, 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.
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0983395
Page 118 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-29-2020 15:07:56 (UTC-05:00) Eastern
Time (US & Canada)
FormSep-29-2020 15:02:21 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983396
Page 119 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-29-2020 15:07:56 (UTC-05:00) Eastern
Time (US & Canada)
1Sep-29-2020 15:02:21 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983397
Page 120 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-29-2020 15:07:56 (UTC-05:00) Eastern
Time (US & Canada)
2Sep-29-2020 15:02:21 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983398
Page 121 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-29-2020 15:07:56 (UTC-05:00) Eastern
Time (US & Canada)
3Sep-29-2020 15:02:21 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983399
Page 122 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-29-2020 15:07:56 (UTC-05:00) Eastern
Time (US & Canada)
4Sep-29-2020 15:02:21 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983400
Page 123 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-29-2020 15:07:56 (UTC-05:00) Eastern
Time (US & Canada)
5Sep-29-2020 15:02:21 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983401
Page 124 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Sep-29-2020 15:07:56 (UTC-05:00) Eastern
Time (US & Canada)
6Sep-29-2020 15:02:21 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983402
Page 125 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Sep-29-2020 15:07:56 (UTC-05:00) Eastern
Time (US & Canada)
7Sep-29-2020 15:02:21 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983403
Page 126 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Sep-29-2020 15:07:56 (UTC-05:00) Eastern
Time (US & Canada)
8Sep-29-2020 15:02:21 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983404
Page 127 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Sep-29-2020 15:07:56 (UTC-05:00) Eastern
Time (US & Canada)
9Sep-29-2020 15:02:21 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983405
Page 128 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-29-2020 15:16:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983406
Page 129 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-29-2020 15:16:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983407
Page 130 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-29-2020 15:16:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983408
Page 131 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-29-2020 15:16:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983409
Page 132 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-29-2020 15:16:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983410
Page 133 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-29-2020 15:16:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983411
Page 134 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Sep-29-2020 15:16:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983412
Page 135 of 506
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-29-2020 15:11:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983413
Page 136 of 506
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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(b) (4), (b) (6)
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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4Sep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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5.bSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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5.bSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.cSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
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ItemDate User Comment
5.cSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.cSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.cSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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5.dSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.dSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.eSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.eSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.eSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.eSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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5.fSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.fSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.fSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.fSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.gSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.gSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.gSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.gSep-29-2020 15:13:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
FormSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
1Sep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.aSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.aSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.aSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.aSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.bSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.bSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.bSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.bSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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5.cSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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5.cSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.cSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.cSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.dSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.dSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.dSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.dSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.eSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.eSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.eSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.fSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.fSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.fSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983478
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.fSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983479
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983480
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983481
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Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983482
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983483
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.hSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983484
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Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.hSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983485
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Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.hSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983486
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Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.hSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983487
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Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983488
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Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983489
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Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983490
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Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983491
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Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983492
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983493
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Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0983494
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Visit on Aug/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jSep-29-2020 15:14:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983495
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-29-2020 15:14:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0983496
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-29-2020 15:14:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0983497
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Visit on Aug/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aSep-29-2020 15:14:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0983498
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aSep-29-2020 15:14:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0983499
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aSep-29-2020 15:14:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0983500
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aSep-29-2020 15:14:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0983501
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Visit on Aug/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-29-2020 15:14:30 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0983502
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-29-2020 15:14:30 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0983503
Page 226 of 506
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Aug/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aSep-29-2020 15:14:30 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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1Sep-29-2020 15:14:55 (UTC-05:00) Eastern
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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(b) (4), (b) (6)
(b) (4), (b) (6)
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(b) (4), (b) (6)
(b) (4), (b) (6)
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(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
2Sep-29-2020 15:16:26 (UTC-05:00) Eastern
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(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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3Sep-29-2020 15:16:26 (UTC-05:00) Eastern
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(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-29-2020 15:16:26 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-29-2020 15:16:26 (UTC-05:00) Eastern
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(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Sep-29-2020 15:16:26 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-29-2020 15:16:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-29-2020 15:16:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0983518
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Visit: POT_COVID_ILL 1 - Unscheduled
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-29-2020 15:16:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0983519
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Visit: POT_COVID_ILL 1 - Unscheduled
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-29-2020 15:16:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-24-2020 10:15:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Aug-24-2020 10:15:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Aug-24-2020 10:15:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Aug-24-2020 10:15:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Aug-24-2020 10:15:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Aug-24-2020 10:15:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Aug-24-2020 10:15:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Aug-24-2020 10:15:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Aug-24-2020 10:15:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Aug-24-2020 10:15:34 (UTC-05:00) Eastern
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(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
10Aug-24-2020 10:15:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
FormAug-24-2020 10:15:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Aug-24-2020 10:15:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Aug-24-2020 10:15:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Aug-24-2020 10:15:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Aug-24-2020 10:15:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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FormSep-23-2020 14:54:11 (UTC-05:00) Eastern
Time (US & Canada)
FormAug-24-2020 10:16:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Time (US & Canada)
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(b) (4), (b) (6)
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ItemDate User Comment
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Time (US & Canada)
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
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Time (US & Canada)
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
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Time (US & Canada)
4Aug-24-2020 10:16:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0983542
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Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5Sep-23-2020 14:54:11 (UTC-05:00) Eastern
Time (US & Canada)
5Aug-24-2020 10:16:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
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Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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ItemDate User Comment
6Sep-23-2020 14:54:11 (UTC-05:00) Eastern
Time (US & Canada)
6Aug-24-2020 10:16:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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ItemDate User Comment
7Sep-23-2020 14:54:11 (UTC-05:00) Eastern
Time (US & Canada)
7Aug-24-2020 10:16:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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ItemDate User Comment
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Time (US & Canada)
8Aug-24-2020 10:16:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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ItemDate User Comment
9Sep-23-2020 14:54:11 (UTC-05:00) Eastern
Time (US & Canada)
9Aug-24-2020 10:16:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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ItemDate User Comment
10Sep-23-2020 14:54:11 (UTC-05:00) Eastern
Time (US & Canada)
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Time (US & Canada)Not Applicable
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-24-2020 10:16:10 (UTC-05:00) Eastern
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090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
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***Confidential***
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Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Aug-24-2020 10:16:10 (UTC-05:00) Eastern
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Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Aug-24-2020 10:16:10 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Aug-24-2020 10:16:10 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Aug-24-2020 10:16:10 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Aug-24-2020 10:16:10 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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***Confidential***
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae30f9\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
…[truncated]