Document text
Page 1 of 472
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816362
Page 2 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/1/2020
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816363
Page 3 of 472
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11781061]
2.Birth Date: /1982
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:
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0816364
Page 4 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816365
Page 5 of 472
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816366
Page 6 of 472
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816367
Page 7 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left torn labrum]
Start Date: Mar/UNK/2020
Ongoing: NO
End Date:
May/18/2020
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left labrum repair]
Start Date: May/18/2020
Ongoing: NO
End Date:
May/18/2020
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety]
Start Date: Mar/UNK/2020
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left shoulder pain]
Start Date: Mar/UNK/2020
Ongoing: YES
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816368
Page 8 of 472
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
2.Weight: [172.0]
3.Unit: LB
4.Height: [70.0]
5.Unit: in
6.Body Mass Index: [24.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816369
Page 9 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/1/2020
2.Randomization Number: [75963]
3.Randomization Group: [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816370
Page 10 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BPY8BD]
5.bSample ID [BPY8BF]
5.cSample ID [BPY8BG]
5.dSample ID [BNWP0N]
5.eSample ID [BNWP0P]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816371
Page 11 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BPY8BC]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816372
Page 12 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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/1/2020 10:08
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816373
Page 13 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816374
Page 14 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816375
Page 15 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816376
Page 16 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [BPW3TX]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816377
Page 17 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Sep/22/2020
Reason(s) for Temporary Delay of Vaccination
RECENT SYSTEMIC CORTICOSTEROID TREATMENT
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/14/2020 10:09
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816378
Page 18 of 472
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816379
Page 19 of 472
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW44Y]
5.bSample ID [BRVDGV]
5.cSample ID [BRVDGW]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816380
Page 20 of 472
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816381
Page 21 of 472
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816382
Page 22 of 472
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816383
Page 23 of 472
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816384
Page 24 of 472
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816385
Page 25 of 472
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816386
Page 26 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816387
Page 27 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/5/2020
2.Date of First Symptom Started: Oct/2/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/11/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
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? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816388
Page 28 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816389
Page 29 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of C
ollectionSpecimen Typ
eSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/5/2020
SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
2.Oct/9/2020
SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816390
Page 30 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/5/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [NALT unknown] Comments
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816391
Page 31 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/9/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT unknown]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816392
Page 32 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/5/2020
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 [CV18388]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816393
Page 33 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Telehealth visit. Self swab done.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816394
Page 34 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: YES
Number of Visits or Contacts:
[2]
Health Care Utilization Other
2.Other Type of Practitioner Specify: [Drive through clinic] Comments
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816395
Page 35 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816396
Page 36 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816397
Page 37 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816398
Page 38 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816399
Page 39 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816400
Page 40 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applic
able Not Applic
able Not Applic
able Sponsor-Defined I
dentifierTest: 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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816401
Page 41 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816402
Page 42 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816403
Page 43 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816404
Page 44 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816405
Page 45 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1.Not Applicabl
e Not Applicable 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
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816406
Page 46 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816407
Page 47 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816408
Page 48 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816409
Page 49 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816410
Page 50 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816411
Page 51 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816412
Page 52 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816413
Page 53 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816414
Page 54 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816415
Page 55 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816416
Page 56 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816417
Page 57 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816418
Page 58 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816419
Page 59 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816420
Page 60 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816421
Page 61 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816422
Page 62 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816423
Page 63 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/5/2020
2.Date of First Symptom Started: Oct/14/2020
3.Symptoms Ongoing? YES
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? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816424
Page 64 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.aSymptoms - Other Text: [headache]
5.bSymptoms - Other Text: [nausea]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816425
Page 65 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Type Form Instance
1.Not Applicable Not Applicab
le Not Applicable Not Applicable Not Applicab
le Repeating
Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816426
Page 66 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816427
Page 67 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/5/2020
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 [CV57012]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816428
Page 68 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[self swab only]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816429
Page 69 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: YES
Number of Visits or Contacts:
[2]
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816430
Page 70 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816431
Page 71 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816432
Page 72 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816433
Page 73 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816434
Page 74 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816435
Page 75 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1. Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816436
Page 76 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816437
Page 77 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816438
Page 78 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816439
Page 79 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816440
Page 80 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816441
Page 81 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816442
Page 82 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816443
Page 83 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816444
Page 84 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816445
Page 85 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816446
Page 86 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816447
Page 87 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816448
Page 88 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816449
Page 89 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/02/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816450
Page 90 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/02/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW42H]
5.bSample ID [BRVF2F]
5.cSample ID [BRVF2G]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816451
Page 91 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Dec/03/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/3/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816452
Page 92 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Dec/03/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/3/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR7GTK]
5.bSample ID [BRVDPS]
5.cSample ID [BRVDPT]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816453
Page 93 of 472
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816454
Page 94 of 472
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unplanned Assessments
1.Assessments
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816455
Page 95 of 472
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/11/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816456
Page 96 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816457
Page 97 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816458
Page 98 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816459
Page 99 of 472
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instan
ce
1. ADVERSE
EVENT 1 Chills Sep/2/2020 UN
K:UNK NO
End Date Time:
Sep/2/2020 UNK:U
NK
Repeating
Pages
2. ADVERSE
EVENT 2 injection site soreness
Sep/2/2020 UN
K:UNK NO
End Date Time:
Sep/2/2020 UNK:U
NK
Repeating
Pages
3. ADVERSE
EVENT 3 myalgias Sep/2/2020 UN
K:UNK NO
End Date Time:
Sep/2/2020 UNK:U
NK
Repeating
Pages
4. ADVERSE
EVENT 4 headache Sep/2/2020 UN
K:UNK NO
End Date Time:
Sep/2/2020 UNK:U
NK
Repeating
Pages
5. DELETED ADVERSE
EVENT 5 chills Oct/14/2020 20
:00 NO
End Date Time:
Oct/15/2020 09:00
Repeating
Pages
6. DELETED ADVERSE
EVENT 6 myalgias Oct/14/2020 20
:00 YES Repeating
Pages
7. DELETED ADVERSE
EVENT 7 headache Oct/14/2020 20
:00 NO
End Date Time:
Oct/15/2020 13:00
Repeating
Pages
8. DELETED ADVERSE
EVENT 8 headache - intermitte
nt Oct/15/2020 U
NK:UNK YES Repeating
Pages
9. ADVERSE 9 sternum pain Oct/15/2020 U YES Repeating
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816460
Page 100 of 472
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instan
ce
EVENT NK:UNK Pages
10. DELETED ADVERSE
EVENT 10 intermittent nausea Oct/16/2020 U
NK:UNK YES Repeating
Pages
11. ADVERSE
EVENT 11 partner exposure duri
ng pregnancy Oct/2/2020 UN
K:UNK YES Repeating
Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816461
Page 101 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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)[Chills]
4.Start Date Time: Sep/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/2/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816462
Page 102 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816463
Page 103 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[injection site soreness]
4.Start Date Time: Sep/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/2/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816464
Page 104 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816465
Page 105 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[myalgias]
4.Start Date Time: Sep/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/2/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816466
Page 106 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816467
Page 107 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[headache]
4.Start Date Time: Sep/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/2/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816468
Page 108 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816469
Page 109 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[chills]
4.Start Date Time: Oct/14/2020 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/15/2020 09:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816470
Page 110 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816471
Page 111 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[myalgias]
4.Start Date Time: Oct/14/2020 20:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816472
Page 112 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816473
Page 113 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[headache]
4.Start Date Time: Oct/14/2020 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/15/2020 13:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816474
Page 114 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816475
Page 115 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[headache - intermittent ]
4.Start Date Time: Oct/15/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816476
Page 116 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816477
Page 117 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[sternum pain]
4.Start Date Time: Oct/15/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816478
Page 118 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816479
Page 119 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [10]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[intermittent nausea ]
4.Start Date Time: Oct/16/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816480
Page 120 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816481
Page 121 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [11]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[partner exposure during pregnancy]
4.Start Date Time: Oct/2/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[fratnerization]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816482
Page 122 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816483
Page 123 of 472
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
1. Repeating
Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816484
Page 124 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816485
Page 125 of 472
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816486
Page 126 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816487
Page 127 of 472
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816488
Page 128 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816489
Page 129 of 472
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816490
Page 130 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816491
Page 131 of 472
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816492
Page 132 of 472
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816493
Page 133 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816494
Page 134 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816495
Page 135 of 472
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816496
Page 136 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816497
Page 137 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816498
Page 138 of 472
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816499
Page 139 of 472
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816500
Page 140 of 472
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816501
Page 141 of 472
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816502
Page 142 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816503
Page 143 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816504
Page 144 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/15/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816505
Page 145 of 472
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816506
Page 146 of 472
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816507
Page 147 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/11/2020
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816508
Page 148 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816509
Page 149 of 472
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816510
Page 150 of 472
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-01-2020 11:30:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816511
Page 151 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-21-2020 16:22:10 (UTC-06:00) Central
Time (US & Canada)
FormOct-06-2020 09:04:14 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816512
Page 152 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-21-2020 16:22:10 (UTC-06:00) Central Time
(US & Canada)
1Oct-06-2020 09:04:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816513
Page 153 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-21-2020 16:22:10 (UTC-06:00) Central Time
(US & Canada)
2Oct-06-2020 09:04:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816514
Page 154 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-21-2020 16:22:10 (UTC-06:00) Central Time
(US & Canada)
3Oct-06-2020 09:04:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816515
Page 155 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Oct-21-2020 16:22:10 (UTC-06:00) Central Time
(US & Canada)
4Oct-06-2020 09:04:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816516
Page 156 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Oct-21-2020 16:22:10 (UTC-06:00) Central Time
(US & Canada)
5Oct-06-2020 09:04:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816517
Page 157 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Oct-21-2020 16:22:10 (UTC-06:00) Central Time
(US & Canada)
6Oct-06-2020 09:04:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816518
Page 158 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Oct-21-2020 16:22:10 (UTC-06:00) Central Time
(US & Canada)
7Oct-06-2020 09:04:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816519
Page 159 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Oct-21-2020 16:22:10 (UTC-06:00) Central Time
(US & Canada)
8Oct-06-2020 09:04:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816520
Page 160 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
9Oct-21-2020 16:22:10 (UTC-06:00) Central Time
(US & Canada)
9Oct-06-2020 09:04:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816521
Page 161 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-14-2020 14:48:08 (UTC-06:00) Central Time
(US & Canada)
2Oct-05-2020 11:50:23 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816522
Page 162 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-05-2020 11:47:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816523
Page 163 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-05-2020 11:47:04 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816524
Page 164 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-05-2020 11:47:04 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816525
Page 165 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-05-2020 11:47:04 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816526
Page 166 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Oct-05-2020 11:47:04 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816527
Page 167 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Oct-05-2020 11:47:04 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816528
Page 168 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Oct-05-2020 11:47:04 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816529
Page 169 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-04-2020 16:53:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormNov-04-2020 16:52:51 (UTC-06:00) Central
Time (US & Canada)
FormOct-05-2020 11:48:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816530
Page 170 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-04-2020 16:53:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Nov-04-2020 16:52:51 (UTC-06:00) Central Time
(US & Canada)
1Oct-05-2020 11:48:17 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816531
Page 171 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-04-2020 16:53:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Nov-04-2020 16:52:51 (UTC-06:00) Central Time
(US & Canada)
2Oct-05-2020 11:48:17 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816532
Page 172 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-04-2020 16:53:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Nov-04-2020 16:52:51 (UTC-06:00) Central Time
(US & Canada)
3Oct-05-2020 11:48:17 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816533
Page 173 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-04-2020 16:53:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4Nov-04-2020 16:52:51 (UTC-06:00) Central Time
(US & Canada)
4Oct-05-2020 11:48:17 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816534
Page 174 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-05-2020 11:56:29 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816535
Page 175 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816536
Page 176 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816537
Page 177 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816538
Page 178 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Oct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816539
Page 179 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816540
Page 180 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816541
Page 181 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816542
Page 182 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816543
Page 183 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816544
Page 184 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816545
Page 185 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816546
Page 186 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816547
Page 187 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816548
Page 188 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816549
Page 189 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816550
Page 190 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816551
Page 191 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816552
Page 192 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816553
Page 193 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816554
Page 194 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816555
Page 195 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816556
Page 196 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816557
Page 197 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816558
Page 198 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816559
Page 199 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816560
Page 200 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816561
Page 201 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816562
Page 202 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816563
Page 203 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816564
Page 204 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816565
Page 205 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816566
Page 206 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-05-2020 11:56:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816567
Page 207 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-05-2020 11:56:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816568
Page 208 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816569
Page 209 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816570
Page 210 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816571
Page 211 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Oct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816572
Page 212 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816573
Page 213 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816574
Page 214 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816575
Page 215 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816576
Page 216 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816577
Page 217 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816578
Page 218 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816579
Page 219 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816580
Page 220 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816581
Page 221 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816582
Page 222 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816583
Page 223 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816584
Page 224 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816585
Page 225 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816586
Page 226 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816587
Page 227 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816588
Page 228 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816589
Page 229 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816590
Page 230 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816591
Page 231 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816592
Page 232 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816593
Page 233 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816594
Page 234 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816595
Page 235 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 fOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816596
Page 236 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816597
Page 237 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816598
Page 238 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816599
Page 239 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816600
Page 240 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816601
Page 241 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816602
Page 242 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816603
Page 243 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5 hOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816604
Page 244 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816605
Page 245 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816606
Page 246 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816607
Page 247 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816608
Page 248 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816609
Page 249 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816610
Page 250 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816611
Page 251 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jOct-05-2020 11:56:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816612
Page 252 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-05-2020 11:51:05 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816613
Page 253 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-05-2020 11:51:05 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816614
Page 254 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aOct-05-2020 11:51:05 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816615
Page 255 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aOct-05-2020 11:51:05 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816616
Page 256 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aOct-05-2020 11:51:05 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816617
Page 257 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aOct-05-2020 11:51:05 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816618
Page 258 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-05-2020 11:51:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816619
Page 259 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-05-2020 11:51:18 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816620
Page 260 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aOct-05-2020 11:51:18 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816621
Page 261 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-05-2020 11:51:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816622
Page 262 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-05-2020 11:51:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816623
Page 263 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-05-2020 11:51:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816624
Page 264 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-05-2020 11:51:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816625
Page 265 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-05-2020 11:48:58 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816626
Page 266 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-05-2020 11:48:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816627
Page 267 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-05-2020 11:48:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816628
Page 268 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-05-2020 11:48:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816629
Page 269 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Oct-05-2020 11:48:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816630
Page 270 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Oct-05-2020 11:48:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816631
Page 271 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Oct-05-2020 11:48:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816632
Page 272 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-05-2020 11:49:12 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816633
Page 273 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-05-2020 11:49:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816634
Page 274 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-05-2020 11:49:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816635
Page 275 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-05-2020 11:49:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816636
Page 276 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/05/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Oct-05-2020 11:49:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816637
Page 277 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-05-2020 11:14:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816638
Page 278 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-05-2020 11:14:52 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816639
Page 279 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-05-2020 11:14:52 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816640
Page 280 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-05-2020 11:14:52 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816641
Page 281 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-05-2020 11:14:52 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816642
Page 282 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Nov-05-2020 11:14:52 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816643
Page 283 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Nov-05-2020 11:14:52 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816644
Page 284 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Nov-05-2020 11:14:52 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816645
Page 285 of 472
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781061 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Nov-05-2020 11:14:52 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fbb\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0816646
Page 286 of 472
…[truncated]