125742 S1 M5 CRF c4591001 1052 10521172

Document text

Page 1 of 1141
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914265
Page 2 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/25/2020
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(b) (4)
FDA-CBER-2021-5683-0914266
Page 3 of 1141
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10521172]
2.Birth Date: 1986
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:
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0914267
Page 4 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914268
Page 5 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914269
Page 6 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
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(b) (4)
FDA-CBER-2021-5683-0914270
Page 7 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
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(b) (4)
FDA-CBER-2021-5683-0914271
Page 8 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
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(b) (4)
FDA-CBER-2021-5683-0914272
Page 9 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
2.Weight: [195.0]
3.Unit: LB
4.Height: [60.0]
5.Unit: in
6.Body Mass Index: [38.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914273
Page 10 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/25/2020
2.Randomization Number: [100135]
3.Randomization Group: [ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914274
Page 11 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BP359M]
5.bSample ID [BP359N]
5.cSample ID [BP359P]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914275
Page 12 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BP38SN]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914276
Page 13 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: Sep/25/2020 12:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914277
Page 14 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECTComments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914278
Page 15 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914279
Page 16 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914280
Page 17 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP35BT]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914281
Page 18 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: Oct/14/2020 11:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914282
Page 19 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/16/2020
2.Erroneous Visit
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914283
Page 20 of 1141
***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, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/16/2020
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 [BLB6YB]
5.bSample ID [BLB6YC]
5.cSample ID [BP38X0]
5.dSample ID [BP38X1]
5.eSample ID [BP38X2]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914284
Page 21 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914285
Page 22 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/29/2020
2.Date of First Symptom Started: Oct/27/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/27/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
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? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914286
Page 23 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914287
Page 24 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914288
Page 25 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914289
Page 26 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914290
Page 27 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914291
Page 28 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914292
Page 29 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914293
Page 30 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914294
Page 31 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
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Page 32 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914296
Page 33 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914297
Page 34 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined I
dentifierTest:Result:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914298
Page 35 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914299
Page 36 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914300
Page 37 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914301
Page 38 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914302
Page 39 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914303
Page 40 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914304
Page 41 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914305
Page 42 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914306
Page 43 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914307
Page 44 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914308
Page 45 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914309
Page 46 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914310
Page 47 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914311
Page 48 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Oxygen Saturation
Not Done  Not Done Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914312
Page 49 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914313
Page 50 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914314
Page 51 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914315
Page 52 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914316
Page 53 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914317
Page 54 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914318
Page 55 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914319
Page 56 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914320
Page 57 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/28/2021
2.Date of First Symptom Started: Jan/26/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/27/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914321
Page 58 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914322
Page 59 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Collect
ionSpecimen T
ypeSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Type Form Instance
 1.Not Applicable  Not Applicab
le Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914323
Page 60 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914324
Page 61 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[subject came into site to be assesed]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914325
Page 62 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
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 [BR2JJC]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914326
Page 63 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914327
Page 64 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914328
Page 65 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914329
Page 66 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914330
Page 67 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914331
Page 68 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914332
Page 69 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable
 Not Appli
cable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914333
Page 70 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914334
Page 71 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914335
Page 72 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914336
Page 73 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914337
Page 74 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914338
Page 75 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914339
Page 76 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914340
Page 77 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914341
Page 78 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914342
Page 79 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914343
Page 80 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914344
Page 81 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Jan/28/2021 Record Identifier: Systolic: Diastolic:
1  129  90 Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914345
Page 82 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/28/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [129]
Diastolic: [90]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [79]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914346
Page 83 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Jan/28/2021 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914347
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/28/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914348
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914349
Page 86 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914350
Page 87 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914351
Page 88 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914352
Page 89 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914353
Page 90 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/28/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914354
Page 91 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914355
Page 92 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/9/2021
2.Date of First Symptom Started: Feb/5/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/5/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
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
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914356
Page 93 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptoms - Other
5.aSymptoms - Other Text: [seizure]
5.bSymptoms - Other Text: [ ]
5.cSymptoms - Other Text: [ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914357
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Collect
ionSpecimen T
ypeSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Type Form Instance
 1.Not Applicable  Not Applicab
le Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914358
Page 95 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914359
Page 96 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[subject came into site to be assessed]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
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(b) (4)
FDA-CBER-2021-5683-0914360
Page 97 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/9/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR2JLY]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914361
Page 98 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: YES
Number of Visits or Contacts:
[1]
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: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914362
Page 99 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914363
Page 100 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914364
Page 101 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: 2
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914365
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914366
Page 103 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914367
Page 104 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable
 Not Appli
cable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914368
Page 105 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914369
Page 106 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914370
Page 107 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914371
Page 108 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914372
Page 109 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914373
Page 110 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914374
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914375
Page 112 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914376
Page 113 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914377
Page 114 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914378
Page 115 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914379
Page 116 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Feb/9/2021 Record Identifier: Systolic: Diastolic:
1  127  88 Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914380
Page 117 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/9/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [127]
Diastolic: [88]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [65]
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(b) (4)
FDA-CBER-2021-5683-0914381
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Feb/9/2021 Record Identifier: Oxygen Saturation
1  99.0 Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914382
Page 119 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/9/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914383
Page 120 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914384
Page 121 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914385
Page 122 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914386
Page 123 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914387
Page 124 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Feb/5/2021  CHEST  CT SCAN  NORMAL  Repeating Pages
 2.Feb/5/2021  HEAD  CT SCAN  NORMAL  Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914388
Page 125 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Feb/5/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: NORMAL
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914389
Page 126 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Feb/09/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Feb/5/2021
2.Location of Assessment: HEAD
3.Type of Imaging Exam: CT SCAN
4.Assessment: NORMAL
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914390
Page 127 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_D
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914391
Page 128 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Applicable
//Comments
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Applicable Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Applicable Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Applicable Comments
4.dSymptoms: CHILLS
Was symptom present? Not Applicable Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Applicable Comments
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Applicable Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914392
Page 129 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Applicable Comments
4.hSymptoms: DIARRHEA
Was symptom present? Not Applicable Comments
4.iSymptoms: VOMITING
Was symptom present? Not Applicable Comments
Symptoms - Other
5.Symptoms - Other Text: Not Applicable
[ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914393
Page 130 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Collect
ionSpecimen T
ypeSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Type Form Instance
 1.Not Applicable  Not Applicab
le Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914394
Page 131 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914395
Page 132 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914396
Page 133 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914397
Page 134 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: Not Applicable Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: Not Applicable Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: Not Applicable Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: Not Applicable Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: Not Applicable Comments
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: Not Applicable Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: Not Applicable
[ ]Comments
Health Care Utilization
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914398
Page 135 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
3.Has the subject been hospitalized
due to potential COVID-19 illness?Not Applicable Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914399
Page 136 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914400
Page 137 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914401
Page 138 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?Not Applicable Comments
3.Toxicity Grade: Not Applicable Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914402
Page 139 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914403
Page 140 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914404
Page 141 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable
 Not Appli
cable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914405
Page 142 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914406
Page 143 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914407
Page 144 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914408
Page 145 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914409
Page 146 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914410
Page 147 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914411
Page 148 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914412
Page 149 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914413
Page 150 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914414
Page 151 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914415
Page 152 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914416
Page 153 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914417
Page 154 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914418
Page 155 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914419
Page 156 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914420
Page 157 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914421
Page 158 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914422
Page 159 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914423
Page 160 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914424
Page 161 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914425
Page 162 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Mar/05/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914426
Page 163 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/07/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/7/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914427
Page 164 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/7/2020
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 [BLB701]
5.bSample ID [BLB702]
5.cSample ID [BR2J99]
5.dSample ID [BR2J9B]
5.eSample ID [BR2J9C]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914428
Page 165 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Mar/10/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914429
Page 166 of 1141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Mar/10/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/10/2021
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 [BRMTYD]
5.bSample ID [BRMTYF]
5.cSample ID [BRMTYG]
5.dSample ID [BLB76G]
5.eSample ID [BLB76H]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914430
Page 167 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914431
Page 168 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914432
Page 169 of 1141
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914433
Page 170 of 1141
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914434
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***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/29/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Oct/29/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914435
Page 172 of 1141
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Seizure  Feb/5/2021 UN
K:UNK NO
End Date Time:
Feb/5/2021 UNK:UN
K
 Repeating
Pages
 2.ADVERSE E
VENT 2  lactic acidosis (due to possi
ble infection) Feb/5/2021 10:0
0 NO
End Date Time:
Feb/5/2021 12:49
 Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914436
Page 173 of 1141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Seizure]
4.Start Date Time: Feb/5/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/5/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914437
Page 174 of 1141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[n/a]
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[2021148832]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914438
Page 175 of 1141
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
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)[lactic acidosis (due to possible infection)]
4.Start Date Time: Feb/5/2021 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/5/2021 12:49
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).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?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914439
Page 176 of 1141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[n/a]
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[ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914440
Page 177 of 1141
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.Not Applica
ble Not Applicabl
e Not Applica
ble Not Applicable  Not Applicable  Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914441
Page 178 of 1141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914442
Page 179 of 1141
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914443
Page 180 of 1141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914444
Page 181 of 1141
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1. DELETED 1    NO  Levetiraceta
m 500  Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914445
Page 182 of 1141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Answered Queries, Deleted,
Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** 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: 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).[Levetiracetam ] Comments
5.Dose: [500] Comments
6.Dose Unit: mg Comments
7.Dose Frequency: BID Comments
8.Route: ORAL Comments
9.Start Date: Feb/5/2021 Comments
10.Ongoing? YES Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914446
Page 183 of 1141
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryTreatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Start Date Form Instance
 1.Not Applica
ble Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914447
Page 184 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914448
Page 185 of 1141
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914449
Page 186 of 1141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914450
Page 187 of 1141
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914451
Page 188 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914452
Page 189 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914453
Page 190 of 1141
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914454
Page 191 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914455
Page 192 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914456
Page 193 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914457
Page 194 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914458
Page 195 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914459
Page 196 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914460
Page 197 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/7/2021
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914461
Page 198 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914462
Page 199 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/7/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914463
Page 200 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/7/2021
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 [BR2JCL]
5.bSample ID [BR2JCM]
5.cSample ID [BR2JCN]
5.dSample ID [BLB70Y]
5.eSample ID [BLB70Z]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914464
Page 201 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/7/2021
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 [BR2JCV]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914465
Page 202 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/7/2021 10:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914466
Page 203 of 1141
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/6/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914467
Page 204 of 1141
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914468
Page 205 of 1141
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914469
Page 206 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914470
Page 207 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
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 [BR2JJZ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914471
Page 208 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/26/2021 09:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914472
Page 209 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914473
Page 210 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/23/2021
3.Comments: [subject notified staff that there has been no changes to his health since last visit
and he will notify site once he follow-up with specialst]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914474
Page 211 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914475
Page 212 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914476
Page 213 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914477
Page 214 of 1141
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914478
Page 215 of 1141
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/23/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914479
Page 216 of 1141
***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: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/16/2020
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914480
Page 217 of 1141
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914481
Page 218 of 1141
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0914482
Page 219 of 1141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-28-2020 16:23:36 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914483
Page 220 of 1141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-28-2020 16:24:13 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914484
Page 221 of 1141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-28-2020 16:44:00 (UTC-08:00) Pacific
Time (US & Canada)Per monitor subject is to complete Covid-19
Illness diary
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914485
Page 222 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-04-2020 14:41:43 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914486
Page 223 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-04-2020 14:41:43 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914487
Page 224 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-04-2020 14:41:43 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914488
Page 225 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-04-2020 14:41:43 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914489
Page 226 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-04-2020 14:41:43 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914490
Page 227 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Nov-04-2020 14:41:43 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914491
Page 228 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Nov-04-2020 14:41:43 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914492
Page 229 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Nov-04-2020 14:41:43 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914493
Page 230 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Nov-04-2020 14:41:43 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914494
Page 231 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Nov-04-2020 14:41:43 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914495
Page 232 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-04-2020 14:42:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914496
Page 233 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-04-2020 14:42:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914497
Page 234 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-04-2020 14:42:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914498
Page 235 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-04-2020 14:42:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914499
Page 236 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-04-2020 14:42:02 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914500
Page 237 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-04-2020 14:42:20 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914501
Page 238 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-04-2020 14:42:20 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914502
Page 239 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-04-2020 14:42:20 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914503
Page 240 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-04-2020 14:42:20 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914504
Page 241 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-04-2020 14:42:20 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914505
Page 242 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-04-2020 14:43:13 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914506
Page 243 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-04-2020 14:43:13 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914507
Page 244 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-04-2020 14:43:13 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914508
Page 245 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-04-2020 14:43:13 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914509
Page 246 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-04-2020 14:43:13 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914510
Page 247 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Nov-04-2020 14:43:13 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914511
Page 248 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Nov-04-2020 14:43:13 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914512
Page 249 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-04-2020 14:44:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914513
Page 250 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-04-2020 14:44:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914514
Page 251 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-04-2020 14:44:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914515
Page 252 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-04-2020 14:44:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914516
Page 253 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-04-2020 14:44:19 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914517
Page 254 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914518
Page 255 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914519
Page 256 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914520
Page 257 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914521
Page 258 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914522
Page 259 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914523
Page 260 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914524
Page 261 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914525
Page 262 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914526
Page 263 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914527
Page 264 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914528
Page 265 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914529
Page 266 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914530
Page 267 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914531
Page 268 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914532
Page 269 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914533
Page 270 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914534
Page 271 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914535
Page 272 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-04-2020 14:44:34 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d91\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0914536
Page 273 of 1141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1052 Site Name: (1052) Long Beach Clinical Trials Services Inc.
Subject No: 10521172 Subject Initials: ---

…[truncated]