125742 S1 M5 CRF c4591001 1039 10391010

Document text

Page 1 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE
3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905251
Page 2 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/21/2020
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905252
Page 3 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10391010]
2.Birth Date: /1935
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:
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0905253
Page 4 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/21/2020
2.Erroneous Visit
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905254
Page 5 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905255
Page 6 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905256
Page 7 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hearing problems]
Start Date: UNK/UNK/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperopia]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cataracts]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergic rhinitis]
Start Date: UNK/UNK/1955
Ongoing: YES
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905257
Page 8 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[carotid artery stenosis]
Start Date: UNK/UNK/2016
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[high blood pressure]
Start Date: UNK/UNK/1960
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hyperlipidemia]
Start Date: UNK/UNK/2000
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[coronary artery disease]
Start Date: Jul/UNK/2016
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: UNK/UNK/2020
Ongoing: YES
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905258
Page 9 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[oseoarthritis, thumbs and fingers]
Start Date: UNK/UNK/2010
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[torn left shoulder rotator cuff]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[glasses wearer]
Start Date: UNK/UNK/2020
Ongoing: YES
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905259
Page 10 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/21/2020
2.Weight: [88.88]
3.Unit: kg
4.Height: [190.2]
5.Unit: cm
6.Body Mass Index: [24.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905260
Page 11 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/21/2020
2.Randomization Number: [234539]
3.Randomization Group: [ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905261
Page 12 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/21/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BL9WV1]
5.bSample ID [BL9WV2]
5.cSample ID [BN5TCN]
5.dSample ID [BN5TCP]
5.eSample ID [BN5TCR]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905262
Page 13 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/21/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5T0F]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905263
Page 14 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/21/2020 10:59
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905264
Page 15 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905265
Page 16 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905266
Page 17 of 466
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905267
Page 18 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5T3Z]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905268
Page 19 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/9/2020 12:54
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905269
Page 20 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905270
Page 21 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
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 [BPW3CF]
5.bSample ID [BPW3CG]
5.cSample ID [BPW3CH]
5.dSample ID [BRV16S]
5.eSample ID [BRV16T]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905271
Page 22 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905272
Page 23 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905273
Page 24 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905274
Page 25 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905275
Page 26 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905276
Page 27 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905277
Page 28 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020 Comments
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905278
Page 29 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Applicable
//Comments
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Applicable Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Applicable Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Applicable Comments
4.dSymptoms: CHILLS
Was symptom present? Not Applicable Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Applicable Comments
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Applicable Comments
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Applicable Comments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905279
Page 30 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.hSymptoms: DIARRHEA
Was symptom present? Not Applicable Comments
4.iSymptoms: VOMITING
Was symptom present? Not Applicable Comments
Symptoms - Other
5.Symptoms - Other Text: Not Applicable
[ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905280
Page 31 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Type Form Instance
 1.Not Applicable  Not Applicabl
e Not Applicable  Not Applicable  Not Applicab
le Repeating
Pages
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905281
Page 32 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905282
Page 33 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905283
Page 34 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905284
Page 35 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: HEALTH CARE UTILIZATION
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: Not Applicable Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: Not Applicable Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: Not Applicable Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: Not Applicable Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: Not Applicable Comments
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: Not Applicable Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: Not Applicable
[ ]Comments
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?Not Applicable Comments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905285
Page 36 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicabl
e Not Applicabl
e Not Applicab
le Repeating
Pages
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905286
Page 37 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905287
Page 38 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?Not Applicable Comments
3.Toxicity Grade: Not Applicable Comments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905288
Page 39 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#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
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905289
Page 40 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905290
Page 41 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for La
b TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Applic
able Not Applica
ble Not Applic
able Sponsor-Defined Id
entifierTest: Result:
Not Applicable  Not Do
ne Not Applic
able 
Not Applicable  Not Do
ne Not Applic
able 
Not Applicable  Not Do
ne Not Applic
able 
Not Applicable  Not Do
ne Not Applic
able 
Not Applicable  Not Do
ne Not Applic
able 
Not Applicable  Not Do
ne Not Applic
able 
Not Applicable  Not Do
ne Not Applic
able Repeating
Pages
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905291
Page 42 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905292
Page 43 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905293
Page 44 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905294
Page 45 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905295
Page 46 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applic
able Not Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable Repeating
Pages
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905296
Page 47 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905297
Page 48 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905298
Page 49 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905299
Page 50 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905300
Page 51 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905301
Page 52 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905302
Page 53 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Done  Not Applicable  Not Applicable Repeating Pages
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905303
Page 54 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905304
Page 55 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Done  Not Applicable Repeating Pages
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905305
Page 56 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905306
Page 57 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905307
Page 58 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905308
Page 59 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applic
able Repeating
Pages
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905309
Page 60 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905310
Page 61 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905311
Page 62 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905312
Page 63 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905313
Page 64 of 466
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905314
Page 65 of 466
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/09/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/9/2020
2.Erroneous Visit
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905315
Page 66 of 466
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/09/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905316
Page 67 of 466
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/09/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Dec/9/2020
Contact Outcome:
VISIT NOT ARRANGED, REACTION NO LONGER PRESENT
3.Comments: [Patient's wife contacted the clinic on 09Dec2020 ti report subject died. SAE
submitted.]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905317
Page 68 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/8/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905318
Page 69 of 466
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Nov/18/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905319
Page 70 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905320
Page 71 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905321
Page 72 of 466
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  injection site pain  Sep/9/2020 19:00  NO
End Date Time:
Sep/11/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EV
ENT 2  right arm bruising  Aug/21/2020 11:0
0 NO
End Date Time:
Sep/2/2020 11:00
 Repeating
Pages
 3.ADVERSE EV
ENT 3  INJECTION SITE PAIN  Aug/21/2020 19:0
0 NO
End Date Time:
Aug/23/2020 12:00
 Repeating
Pages
 4.ADVERSE EV
ENT 4  FEVER  Sep/10/2020 07:00
 NO
End Date Time:
Sep/10/2020 19:00
 Repeating
Pages
 5.ADVERSE EV
ENT 5  arthroscloratic cardiovascul
ar disease Nov/18/2020 UN
K:UNK NO
End Date Time:
Nov/18/2020 UNK:UN
K
 Repeating
Pages
 6.ADVERSE EV
ENT 6  hypertensive cardiovascula
r disease Nov/18/2020 UN
K:UNK NO
End Date Time:
Nov/18/2020 UNK:UN
K
 Repeating
Pages
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905322
Page 73 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[injection site pain]
4.Start Date Time: Sep/9/2020 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/11/2020 UNK:UNK
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
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905323
Page 74 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905324
Page 75 of 466
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[right arm bruising]
4.Start Date Time: Aug/21/2020 11:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/2/2020 11:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905325
Page 76 of 466
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905326
Page 77 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[INJECTION SITE PAIN]
4.Start Date Time: Aug/21/2020 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/23/2020 12:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905327
Page 78 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905328
Page 79 of 466
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[FEVER]
4.Start Date Time: Sep/10/2020 07:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/10/2020 19:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905329
Page 80 of 466
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905330
Page 81 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[arthroscloratic cardiovascular disease]
4.Start Date Time: Nov/18/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/18/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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:
[cardiovascular disease]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905331
Page 82 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2020490602]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905332
Page 83 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[hypertensive cardiovascular disease]
4.Start Date Time: Nov/18/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/18/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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:
[cardiovascular disease]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905333
Page 84 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2020490602]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905334
Page 85 of 466
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905335
Page 86 of 466
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905336
Page 87 of 466
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905337
Page 88 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905338
Page 89 of 466
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905339
Page 90 of 466
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905340
Page 91 of 466
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905341
Page 92 of 466
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905342
Page 93 of 466
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905343
Page 94 of 466
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905344
Page 95 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905345
Page 96 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905346
Page 97 of 466
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905347
Page 98 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905348
Page 99 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905349
Page 100 of 466
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905350
Page 101 of 466
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905351
Page 102 of 466
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905352
Page 103 of 466
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905353
Page 104 of 466
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905354
Page 105 of 466
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905355
Page 106 of 466
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905356
Page 107 of 466
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905357
Page 108 of 466
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Dec/9/2020
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Arthrosclorative cardiovascular disease]
2.bCause of Death Status: SECONDARY CAUSE OF DEATH
Cause of Death: [hypertensive cardiovascular disease]
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905358
Page 109 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/18/2020
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905359
Page 110 of 466
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905360
Page 111 of 466
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Gretchen Crook  Approved Jan-21-2021 15:03:34 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GretchenCrook, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905361
Page 112 of 466
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-21-2020 12:15:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905362
Page 113 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: DATE OF VISIT - ILLNESS ONSET - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-17-2020 14:41:51 (UTC-06:00) Central Time
(US & Canada)Entered in error. no covid illness performed
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905363
Page 114 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-21-2020 14:58:47 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905364
Page 115 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-21-2020 14:58:47 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905365
Page 116 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-21-2020 14:58:47 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905366
Page 117 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-21-2020 14:58:47 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905367
Page 118 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.aSep-21-2020 14:58:47 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905368
Page 119 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.bSep-21-2020 14:58:47 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905369
Page 120 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.cSep-21-2020 14:58:47 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905370
Page 121 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.dSep-21-2020 14:58:47 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905371
Page 122 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.eSep-21-2020 14:58:47 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905372
Page 123 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.fSep-21-2020 14:58:47 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905373
Page 124 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.gSep-21-2020 14:58:47 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905374
Page 125 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.hSep-21-2020 14:58:47 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905375
Page 126 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.iSep-21-2020 14:58:47 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905376
Page 127 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-21-2020 14:59:02 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
FormSep-17-2020 13:03:48 (UTC-06:00) Central Time
(US & Canada)
FormSep-11-2020 12:34:06 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905377
Page 128 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-21-2020 14:59:02 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
1Sep-17-2020 13:03:48 (UTC-06:00) Central Time
(US & Canada)
1Sep-11-2020 12:34:06 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905378
Page 129 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-21-2020 14:59:02 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
2Sep-17-2020 13:03:48 (UTC-06:00) Central Time
(US & Canada)
2Sep-11-2020 12:34:06 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905379
Page 130 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-21-2020 14:59:02 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
3Sep-17-2020 13:03:48 (UTC-06:00) Central Time
(US & Canada)
3Sep-11-2020 12:34:06 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905380
Page 131 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-21-2020 14:59:02 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
4Sep-17-2020 13:03:48 (UTC-06:00) Central Time
(US & Canada)
4Sep-11-2020 12:34:06 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905381
Page 132 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-21-2020 14:59:02 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5Sep-17-2020 13:03:48 (UTC-06:00) Central Time
(US & Canada)
5Sep-11-2020 12:34:06 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905382
Page 133 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Sep-21-2020 14:59:02 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
6Sep-17-2020 13:03:48 (UTC-06:00) Central Time
(US & Canada)
6Sep-11-2020 12:34:06 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905383
Page 134 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Sep-21-2020 14:59:02 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
7Sep-17-2020 13:03:48 (UTC-06:00) Central Time
(US & Canada)
7Sep-11-2020 12:34:06 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905384
Page 135 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Sep-21-2020 14:59:02 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
8Sep-17-2020 13:03:48 (UTC-06:00) Central Time
(US & Canada)
8Sep-11-2020 12:34:06 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905385
Page 136 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Sep-21-2020 14:59:02 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
9Sep-17-2020 13:03:48 (UTC-06:00) Central Time
(US & Canada)
9Sep-11-2020 12:34:06 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905386
Page 137 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-21-2020 14:59:18 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905387
Page 138 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-21-2020 14:59:18 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905388
Page 139 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-21-2020 14:59:18 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905389
Page 140 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-21-2020 14:59:18 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905390
Page 141 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-21-2020 14:59:18 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905391
Page 142 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-21-2020 14:59:30 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
FormSep-17-2020 13:04:12 (UTC-06:00) Central Time
(US & Canada)
FormSep-14-2020 09:11:28 (UTC-06:00) Central Time
(US & Canada)Not Done
FormSep-11-2020 12:34:22 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905392
Page 143 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-21-2020 14:59:30 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
1Sep-17-2020 13:04:12 (UTC-06:00) Central Time
(US & Canada)
1Sep-14-2020 09:11:28 (UTC-06:00) Central Time
(US & Canada)Not Done
1Sep-11-2020 12:34:22 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905393
Page 144 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-21-2020 14:59:30 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
2Sep-17-2020 13:04:12 (UTC-06:00) Central Time
(US & Canada)
2Sep-14-2020 09:11:28 (UTC-06:00) Central Time
(US & Canada)Not Done
2Sep-11-2020 12:34:22 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905394
Page 145 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-21-2020 14:59:30 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
3Sep-17-2020 13:04:12 (UTC-06:00) Central Time
(US & Canada)
3Sep-14-2020 09:11:28 (UTC-06:00) Central Time
(US & Canada)Not Done
3Sep-11-2020 12:34:22 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905395
Page 146 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-21-2020 14:59:30 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
4Sep-17-2020 13:04:12 (UTC-06:00) Central Time
(US & Canada)
4Sep-14-2020 09:11:28 (UTC-06:00) Central Time
(US & Canada)Not Done
4Sep-11-2020 12:34:22 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905396
Page 147 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-21-2020 15:00:10 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905397
Page 148 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1.aSep-21-2020 15:00:10 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905398
Page 149 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1.bSep-21-2020 15:00:10 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905399
Page 150 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1.cSep-21-2020 15:00:10 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905400
Page 151 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1.dSep-21-2020 15:00:10 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905401
Page 152 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1.eSep-21-2020 15:00:10 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905402
Page 153 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1.fSep-21-2020 15:00:10 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905403
Page 154 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-21-2020 15:00:10 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905404
Page 155 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-21-2020 15:00:10 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905405
Page 156 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-21-2020 15:00:26 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
FormSep-17-2020 13:06:36 (UTC-06:00) Central Time
(US & Canada)
FormSep-11-2020 12:34:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905406
Page 157 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-21-2020 15:00:26 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
1Sep-17-2020 13:06:36 (UTC-06:00) Central Time
(US & Canada)
1Sep-11-2020 12:34:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905407
Page 158 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-21-2020 15:00:26 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
2Sep-17-2020 13:06:36 (UTC-06:00) Central Time
(US & Canada)
2Sep-11-2020 12:34:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905408
Page 159 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-21-2020 15:00:26 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
3Sep-17-2020 13:06:36 (UTC-06:00) Central Time
(US & Canada)
3Sep-11-2020 12:34:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905409
Page 160 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-21-2020 15:00:26 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
4Sep-17-2020 13:06:36 (UTC-06:00) Central Time
(US & Canada)
4Sep-11-2020 12:34:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905410
Page 161 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-21-2020 15:00:26 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5Sep-17-2020 13:06:36 (UTC-06:00) Central Time
(US & Canada)
5Sep-11-2020 12:34:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905411
Page 162 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Sep-21-2020 15:00:26 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
6Sep-17-2020 13:06:36 (UTC-06:00) Central Time
(US & Canada)
6Sep-11-2020 12:34:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905412
Page 163 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-21-2020 15:01:28 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905413
Page 164 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-21-2020 15:01:28 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905414
Page 165 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-21-2020 15:01:28 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905415
Page 166 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-21-2020 15:01:28 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905416
Page 167 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-21-2020 15:01:45 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
FormSep-17-2020 13:06:02 (UTC-06:00) Central Time
(US & Canada)
FormSep-11-2020 12:34:53 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905417
Page 168 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-21-2020 15:01:45 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
1Sep-17-2020 13:06:02 (UTC-06:00) Central Time
(US & Canada)
1Sep-11-2020 12:34:53 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905418
Page 169 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-21-2020 15:01:45 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
2Sep-17-2020 13:06:02 (UTC-06:00) Central Time
(US & Canada)
2Sep-11-2020 12:34:53 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905419
Page 170 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-21-2020 15:01:45 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
3Sep-17-2020 13:06:02 (UTC-06:00) Central Time
(US & Canada)
3Sep-11-2020 12:34:53 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905420
Page 171 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-21-2020 15:01:45 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
4Sep-17-2020 13:06:02 (UTC-06:00) Central Time
(US & Canada)
4Sep-11-2020 12:34:53 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905421
Page 172 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
FormSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
FormSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905422
Page 173 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
1Sep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
1Sep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905423
Page 174 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
2Sep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
2Sep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905424
Page 175 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
3Sep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
3Sep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905425
Page 176 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
4Sep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
4Sep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905426
Page 177 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.aSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.aSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905427
Page 178 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.aSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.aSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905428
Page 179 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.aSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.aSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905429
Page 180 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.aSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.aSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905430
Page 181 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.bSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.bSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905431
Page 182 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.bSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.bSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905432
Page 183 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.bSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.bSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905433
Page 184 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.bSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.bSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905434
Page 185 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.cSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.cSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905435
Page 186 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.cSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.cSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905436
Page 187 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.cSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.cSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905437
Page 188 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.cSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.cSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905438
Page 189 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.dSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.dSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905439
Page 190 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.dSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.dSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905440
Page 191 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.dSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.dSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905441
Page 192 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.dSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.dSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905442
Page 193 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.eSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.eSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905443
Page 194 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.eSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.eSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905444
Page 195 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.eSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.eSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905445
Page 196 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.eSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.eSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905446
Page 197 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.fSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.fSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905447
Page 198 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.fSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.fSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905448
Page 199 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.fSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.fSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905449
Page 200 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.fSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.fSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905450
Page 201 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.gSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.gSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905451
Page 202 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.gSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.gSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905452
Page 203 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.gSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.gSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905453
Page 204 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-21-2020 15:01:59 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.gSep-17-2020 13:05:35 (UTC-06:00) Central Time
(US & Canada)
5.gSep-11-2020 12:35:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905454
Page 205 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
FormSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
FormSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905455
Page 206 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
1Sep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
1Sep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905456
Page 207 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
2Sep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
2Sep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905457
Page 208 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
3Sep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
3Sep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905458
Page 209 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
4Sep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
4Sep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905459
Page 210 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.aSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.aSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905460
Page 211 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.aSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.aSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905461
Page 212 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.aSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.aSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905462
Page 213 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.aSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.aSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905463
Page 214 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.bSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.bSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905464
Page 215 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.bSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.bSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905465
Page 216 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.bSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.bSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905466
Page 217 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.bSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.bSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905467
Page 218 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.cSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.cSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905468
Page 219 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.cSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.cSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905469
Page 220 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.cSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.cSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905470
Page 221 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.cSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.cSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905471
Page 222 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.dSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.dSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905472
Page 223 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.dSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.dSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905473
Page 224 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.dSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.dSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905474
Page 225 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.dSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.dSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905475
Page 226 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.eSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.eSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905476
Page 227 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.eSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.eSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905477
Page 228 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.eSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.eSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905478
Page 229 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.eSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.eSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905479
Page 230 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.fSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.fSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905480
Page 231 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.fSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.fSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905481
Page 232 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.fSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.fSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905482
Page 233 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.fSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.fSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905483
Page 234 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.gSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.gSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905484
Page 235 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.gSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.gSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905485
Page 236 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.gSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.gSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905486
Page 237 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.gSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.gSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905487
Page 238 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.hSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.hSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905488
Page 239 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.hSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.hSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905489
Page 240 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.hSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.hSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905490
Page 241 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.hSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.hSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905491
Page 242 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.iSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.iSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905492
Page 243 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.iSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.iSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905493
Page 244 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.iSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.iSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905494
Page 245 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.iSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.iSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905495
Page 246 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.jSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.jSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905496
Page 247 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.jSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.jSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905497
Page 248 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.jSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.jSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905498
Page 249 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jSep-21-2020 15:03:11 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
5.jSep-17-2020 13:05:48 (UTC-06:00) Central Time
(US & Canada)
5.jSep-11-2020 12:35:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905499
Page 250 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-21-2020 15:03:38 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
FormSep-17-2020 13:05:26 (UTC-06:00) Central Time
(US & Canada)
FormSep-11-2020 12:35:36 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905500
Page 251 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-21-2020 15:03:38 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
1Sep-17-2020 13:05:26 (UTC-06:00) Central Time
(US & Canada)
1Sep-11-2020 12:35:36 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905501
Page 252 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aSep-21-2020 15:03:38 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
2.aSep-17-2020 13:05:26 (UTC-06:00) Central Time
(US & Canada)
2.aSep-11-2020 12:35:36 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5a\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905502
Page 253 of 466
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aSep-21-2020 15:03:38 (UTC-06:00) Central Time
(US & Canada)Entered in error, no COVID Illness Visit
performed.
Not Applicable
2.aSep
…[truncated]