Document text
Page 1 of 383
***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: 10391038 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
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905859
Page 2 of 383
***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: 10391038 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/26/2020
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905860
Page 3 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10391038]
2.Birth Date: /1944
3.Sex: MALE
4.Ethnicity: NOT REPORTED
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0905861
Page 4 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905862
Page 5 of 383
***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: 10391038 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
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905863
Page 6 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/26/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905864
Page 7 of 383
***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: 10391038 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/1949
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[glaucoma]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergic rhinitis]
Start Date: UNK/UNK/2000
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[high blood pressure]
Start Date: UNK/UNK/2016
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[elevated cholesterol]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905865
Page 8 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[erectile dysfunction]
Start Date: UNK/UNK/2010
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[overactive bladder]
Start Date: UNK/UNK/2010
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypothyroidism]
Start Date: UNK/UNK/2010
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteoarthritis]
Start Date: UNK/UNK/2004
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[recurrent back pain]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905866
Page 9 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[recurrent neck pain]
Start Date: UNK/UNK/2010
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteopenia]
Start Date: UNK/UNK/2004
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[rosacea]
Start Date: UNK/UNK/2000
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[insomnia]
Start Date: UNK/UNK/2010
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[vitamin d deficiency]
Start Date: UNK/UNK/2004
Ongoing: YES
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905867
Page 10 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tobacco use]
Start Date: UNK/UNK/1958
Ongoing: NO
End Date:
UNK/UNK/1968
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[benign pituitary adenoma]
Start Date: UNK/UNK/2016
Ongoing: YES
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Benign enlarged prostate]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2017
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypogonadism]
Start Date: UNK/UNK/2004
Ongoing: YES
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[vasectomy]
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/1980
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905868
Page 11 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[prostate surgery]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905869
Page 12 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
2.Weight: [64.6]
3.Unit: kg
4.Height: [166.4]
5.Unit: cm
6.Body Mass Index: [23.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905870
Page 13 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/26/2020
2.Randomization Number: [241576]
3.Randomization Group: [ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905871
Page 14 of 383
***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: 10391038 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/26/2020
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 [BN5TG2]
5.bSample ID [BN5TG3]
5.cSample ID [BN5TG4]
5.dSample ID [BL9WWM]
5.eSample ID [BL9WWN]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905872
Page 15 of 383
***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: 10391038 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/26/2020
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 [BN5T17]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905873
Page 16 of 383
***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: 10391038 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/26/2020 14:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905874
Page 17 of 383
***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: 10391038 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
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905875
Page 18 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905876
Page 19 of 383
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905877
Page 20 of 383
***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: 10391038 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/17/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5T63]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905878
Page 21 of 383
***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: 10391038 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/17/2020 13:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905879
Page 22 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905880
Page 23 of 383
***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: 10391038 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Information is captured at convalescent visit]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
5.bSample ID [ ]
5.cSample ID [ ]
5.dSample ID [ ]
5.eSample ID [ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905881
Page 24 of 383
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905882
Page 25 of 383
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/11/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGCJ8]
5.bSample ID [BLBDLX]
5.cSample ID [BS6HSK]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905883
Page 26 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905884
Page 27 of 383
***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: 10391038 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 [ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905885
Page 28 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905886
Page 29 of 383
***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: 10391038 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 [ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905887
Page 30 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/11/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905888
Page 31 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/11/2020
2.Date of First Symptom Started: Sep/10/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/11/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905889
Page 32 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locati
onAssay Code and Descripti
onDevice Typ
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905890
Page 33 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905891
Page 34 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV16864]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905892
Page 35 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Patient collected self swab.] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905893
Page 36 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: HEALTH CARE UTILIZATION
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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905894
Page 37 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905895
Page 38 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905896
Page 39 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905897
Page 40 of 383
***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: 10391038 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
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905898
Page 41 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 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
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905899
Page 42 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1.Not Done Not Done Not Done Not Done Sponsor-Defined Ide
ntifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905900
Page 43 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905901
Page 44 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905902
Page 45 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905903
Page 46 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905904
Page 47 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905905
Page 48 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905906
Page 49 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905907
Page 50 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905908
Page 51 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905909
Page 52 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905910
Page 53 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905911
Page 54 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905912
Page 55 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905913
Page 56 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905914
Page 57 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905915
Page 58 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905916
Page 59 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905917
Page 60 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
1.Not Done Not Done Not Done Not Done Not Don
e Repeating
Pages
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905918
Page 61 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905919
Page 62 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905920
Page 63 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905921
Page 64 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/15/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905922
Page 65 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/15/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 10391038 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/15/2020
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 [BPW2SC]
5.bSample ID [BPW2SD]
5.cSample ID [BPW2SF]
5.dSample ID [BRV195]
5.eSample ID [BRV196]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905923
Page 66 of 383
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905924
Page 67 of 383
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905925
Page 68 of 383
***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: 10391038 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/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905926
Page 69 of 383
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905927
Page 70 of 383
***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: 10391038 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:
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905928
Page 71 of 383
***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: 10391038 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 [ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905929
Page 72 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
1.ADVERSE EVE
NT 1 PELVIC FRACTU
RE Nov/15/2020 15:
00 NO
End Date Time:
Dec/8/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EVE
NT 2 FALL Nov/15/2020 15:
00 NO
End Date Time:
Nov/15/2020 15:00
Repeating
Pages
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905930
Page 73 of 383
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10391038 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)[PELVIC FRACTURE]
4.Start Date Time: Nov/15/2020 15:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/8/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
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:
[FALL]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905931
Page 74 of 383
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020482068]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905932
Page 75 of 383
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10391038 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)[FALL]
4.Start Date Time: Nov/15/2020 15:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/15/2020 15:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[CICYLE ACCIDENT]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905933
Page 76 of 383
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905934
Page 77 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905935
Page 78 of 383
***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: 10391038 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[ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905936
Page 79 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of MedicationStart
DateForm Instan
ce
1.1 VACCINATIO
NS NO FLUZONE, INFLUENZA VACCINE, .5
mL, 1 Injection, Intramuscular Oct/7/
2020 Repeating
Pages
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905937
Page 80 of 383
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[FLUZONE, INFLUENZA VACCINE, .5mL, 1 Injection, Intramuscular]
5.Date: Oct/7/2020
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905938
Page 81 of 383
***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: 10391038 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
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905939
Page 82 of 383
***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: 10391038 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?
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905940
Page 83 of 383
***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: 10391038 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
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905941
Page 84 of 383
***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: 10391038 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?
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905942
Page 85 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905943
Page 86 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905944
Page 87 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905945
Page 88 of 383
***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: 10391038 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:
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905946
Page 89 of 383
***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: 10391038 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?
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905947
Page 90 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905948
Page 91 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905949
Page 92 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905950
Page 93 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905951
Page 94 of 383
***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: 10391038 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 [ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905952
Page 95 of 383
***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: 10391038 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 [ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905953
Page 96 of 383
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905954
Page 97 of 383
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905955
Page 98 of 383
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/30/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905956
Page 99 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905957
Page 100 of 383
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905958
Page 101 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/15/2020
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905959
Page 102 of 383
***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: 10391038 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
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905960
Page 103 of 383
***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: 10391038 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 Mar-11-2021 14:07:45 (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.
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905961
Page 104 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-27-2020 09:36:02 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905962
Page 105 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-16-2020 11:41:47 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905963
Page 106 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-16-2020 11:41:47 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905964
Page 107 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-16-2020 11:41:47 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905965
Page 108 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-16-2020 11:41:47 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905966
Page 109 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-16-2020 11:41:47 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905967
Page 110 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-16-2020 11:41:47 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905968
Page 111 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Sep-16-2020 11:41:47 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905969
Page 112 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Sep-16-2020 11:41:47 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905970
Page 113 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Sep-16-2020 11:41:47 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905971
Page 114 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Sep-16-2020 11:41:47 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905972
Page 115 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-06-2020 10:14:57 (UTC-06:00) Central Time
(US & Canada)
FormSep-16-2020 11:42:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905973
Page 116 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-06-2020 10:14:57 (UTC-06:00) Central Time
(US & Canada)
1Sep-16-2020 11:42:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905974
Page 117 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-06-2020 10:14:57 (UTC-06:00) Central Time
(US & Canada)
2Sep-16-2020 11:42:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905975
Page 118 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-06-2020 10:14:57 (UTC-06:00) Central Time
(US & Canada)
3Sep-16-2020 11:42:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905976
Page 119 of 383
***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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-06-2020 10:14:57 (UTC-06:00) Central Time
(US & Canada)
4Sep-16-2020 11:42:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905977
Page 120 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-16-2020 11:43:04 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905978
Page 121 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-16-2020 11:43:04 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905979
Page 122 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-16-2020 11:43:04 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905980
Page 123 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-16-2020 11:43:04 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905981
Page 124 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-16-2020 11:43:04 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905982
Page 125 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-16-2020 11:43:04 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905983
Page 126 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Sep-16-2020 11:43:04 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905984
Page 127 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-16-2020 11:43:54 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905985
Page 128 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-16-2020 11:43:54 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905986
Page 129 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-16-2020 11:43:54 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905987
Page 130 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-16-2020 11:43:54 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905988
Page 131 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-16-2020 11:43:54 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905989
Page 132 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905990
Page 133 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905991
Page 134 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905992
Page 135 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905993
Page 136 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905994
Page 137 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905995
Page 138 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905996
Page 139 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905997
Page 140 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905998
Page 141 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905999
Page 142 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906000
Page 143 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906001
Page 144 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906002
Page 145 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906003
Page 146 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906004
Page 147 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906005
Page 148 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906006
Page 149 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906007
Page 150 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906008
Page 151 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906009
Page 152 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906010
Page 153 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906011
Page 154 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906012
Page 155 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906013
Page 156 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906014
Page 157 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906015
Page 158 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906016
Page 159 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906017
Page 160 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906018
Page 161 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906019
Page 162 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906020
Page 163 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906021
Page 164 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-16-2020 11:44:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906022
Page 165 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906023
Page 166 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906024
Page 167 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906025
Page 168 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906026
Page 169 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906027
Page 170 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906028
Page 171 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906029
Page 172 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906030
Page 173 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906031
Page 174 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906032
Page 175 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906033
Page 176 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906034
Page 177 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906035
Page 178 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906036
Page 179 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906037
Page 180 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906038
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906039
Page 182 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906040
Page 183 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906041
Page 184 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906042
Page 185 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906043
Page 186 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906044
Page 187 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906045
Page 188 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906046
Page 189 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906047
Page 190 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906048
Page 191 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906049
Page 192 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906050
Page 193 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906051
Page 194 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906052
Page 195 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906053
Page 196 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906054
Page 197 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906055
Page 198 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906056
Page 199 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906057
Page 200 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906058
Page 201 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906059
Page 202 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906060
Page 203 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906061
Page 204 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906062
Page 205 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906063
Page 206 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906064
Page 207 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906065
Page 208 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906066
Page 209 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jSep-16-2020 11:44:37 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906067
Page 210 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-18-2020 11:02:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906068
Page 211 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-18-2020 11:02:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906069
Page 212 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aSep-18-2020 11:02:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906070
Page 213 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aSep-18-2020 11:02:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906071
Page 214 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aSep-18-2020 11:02:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906072
Page 215 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aSep-18-2020 11:02:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906073
Page 216 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-18-2020 11:05:11 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906074
Page 217 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-18-2020 11:05:11 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906075
Page 218 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aSep-18-2020 11:05:11 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906076
Page 219 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: OXYGENATION PARAMETERS - 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-18-2020 11:07:30 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906077
Page 220 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: OXYGENATION PARAMETERS - 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-18-2020 11:07:30 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906078
Page 221 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: OXYGENATION PARAMETERS - 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-18-2020 11:07:30 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906079
Page 222 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: OXYGENATION PARAMETERS - 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-18-2020 11:07:30 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906080
Page 223 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-18-2020 11:07:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906081
Page 224 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-18-2020 11:07:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906082
Page 225 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-18-2020 11:07:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906083
Page 226 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-18-2020 11:07:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906084
Page 227 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-18-2020 11:07:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906085
Page 228 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-18-2020 11:07:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906086
Page 229 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Sep-18-2020 11:07:44 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906087
Page 230 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: IMAGING - 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-18-2020 11:08:00 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906088
Page 231 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: IMAGING - 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-18-2020 11:08:00 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906089
Page 232 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: IMAGING - 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-18-2020 11:08:00 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906090
Page 233 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: IMAGING - 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-18-2020 11:08:00 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906091
Page 234 of 383
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/11/2020Form: IMAGING - 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: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-18-2020 11:08:00 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906092
Page 235 of 383
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Gretchen Crook Approved Mar-11-2021 14:07:45 (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.
N/A Mar-11-2021 13:42:54 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gretchen Crook Approved Mar-09-2021 12:38:23 (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.
Gretchen Crook N/A Feb-19-2021 14:48:48 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gretchen Crook Approved Jan-21-2021 15:21:42 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906093
Page 236 of 383
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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.
N/A Dec-04-2020 16:51:34 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gretchen Crook Approved Nov-06-2020 11:15:51 (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.
N/A Nov-06-2020 10:14:57 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gretchen Crook Approved Oct-30-2020 16:45:47 (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.
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906094
Page 237 of 383
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
N/A Oct-30-2020 08:33:30 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gretchen Crook Approved Oct-23-2020 13:04:55 (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.
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906095
Page 238 of 383
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-27-2020 09:35:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-27-2020 09:35:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906096
Page 239 of 383
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-27-2020 09:35:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/26/2020Initial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906097
Page 240 of 383
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-27-2020 09:35:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10391038Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-27-2020 09:35:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1944Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020 09:35:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-27-2020 09:35:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT REPORTEDInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-27-2020 09:35:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906098
Page 241 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020 09:35:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906099
Page 242 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-27-2020 09:36:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-27-2020 09:36:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020 09:36:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906100
Page 243 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-27-2020 09:41:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:hearing proble
ms
Start Date: UNK/UNK/19
49
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:41:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:41:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hearing problemsInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-27-2020 09:41:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1949Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-27-2020 09:41:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906101
Page 244 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-27-2020 09:42:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:glaucoma
Start Date: UNK/UNK/20
17
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:42:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:42:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
glaucomaInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-27-2020 09:42:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-27-2020 09:42:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-27-2020 09:43:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:seasonal allergic r
hinitis
Start Date: UNK/UNK/2000Initial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906102
Page 245 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:43:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:43:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
seasonal allergic rhinitisInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-27-2020 09:43:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-27-2020 09:43:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-27-2020 09:43:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:high blood press
ure
Start Date: UNK/UNK/201
6
Ongoing: YESInitial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906103
Page 246 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:43:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:43:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
high blood pressureInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-27-2020 09:43:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-27-2020 09:43:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-27-2020 09:43:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:elevated cholest
erol
Start Date: UNK/UNK/201
6
Ongoing: YESInitial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906104
Page 247 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:43:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:43:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
elevated cholesterolInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-27-2020 09:43:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-27-2020 09:43:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-27-2020 09:44:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Te
rm:erectile dysfunct
ion
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906105
Page 248 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:44:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:44:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
erectile dysfunctionInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-27-2020 09:44:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-27-2020 09:44:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-27-2020 09:44:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Te
rm:overactive blad
der
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906106
Page 249 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:44:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:44:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
overactive bladderInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-27-2020 09:44:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-27-2020 09:44:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-27-2020 09:45:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Ter
m:hypothyroidis
m
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906107
Page 250 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:45:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:45:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hypothyroidismInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-27-2020 09:45:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-27-2020 09:45:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-27-2020 09:45:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Ter
m:osteoarthritis
Start Date: UNK/UNK/20
04
Ongoing: YESInitial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906108
Page 251 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:45:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:45:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
osteoarthritisInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-27-2020 09:45:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2004Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-27-2020 09:45:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-27-2020 09:47:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Te
rm:recurrent back p
ain
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906109
Page 252 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:47:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:47:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
recurrent back painInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-27-2020 09:47:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-27-2020 09:47:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906110
Page 253 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.k
Date Location User Value Reason
Aug-27-2020 09:49:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 11
Medical History Te
rm:recurrent neck p
ain
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:49:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:49:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
recurrent neck painInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-27-2020 09:49:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-27-2020 09:49:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-27-2020 09:52:59
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry: Transcription Error
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906111
Page 254 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) Line/MH Number: 12
Medical History Te
rm:osteopenia
Start Date: UNK/UNK/20
04
Ongoing: YES
Aug-27-2020 09:51:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 12
Medical History Te
rm:oseopenia
Start Date: UNK/UNK/20
04
Ongoing: YESInitial Entry
1.l Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:51:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:52:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
osteopeniaTranscription Error
Aug-27-2020 09:51:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
oseopeniaInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-27-2020 09:51:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2004Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-27-2020 09:51:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906112
Page 255 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.m
Date Location User Value Reason
Aug-27-2020 09:52:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 13
Medical History Ter
m:rosacea
Start Date: UNK/UNK/20
00
Ongoing: YESInitial Entry
1.m Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:52:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:52:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
rosaceaInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-27-2020 09:52:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-27-2020 09:52:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Aug-27-2020 09:52:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 14Initial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906113
Page 256 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History Ter
m:insomnia
Start Date: UNK/UNK/20
10
Ongoing: YES
1.n Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:52:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:52:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
insomniaInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-27-2020 09:52:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-27-2020 09:52:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Aug-27-2020 09:53:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 15
Medical History T
erm:vitamin d deficie
ncy
Start Date: UNK/UNK/200
4
Ongoing: YESInitial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906114
Page 257 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.o Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:53:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:53:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
vitamin d deficiencyInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-27-2020 09:53:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2004Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-27-2020 09:53:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Aug-27-2020 09:54:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 16
Medical History T
erm:tobacco use
Start Date: UNK/UNK/1958
Ongoing: NO
End Date:
UNK/UNK/1
968Initial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906115
Page 258 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.p Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:54:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 09:54:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
tobacco useInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-27-2020 09:54:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1958Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-27-2020 09:54:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1968Initial Entry
1.q
Date Location User Value Reason
Oct-21-2020 17:49:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:17
Medical History
Term:benign pituitary a
denoma
Start Date: UNK/UNK/2016
Ongoing: YESTranscription Error
Aug-27-2020 09:55:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 17
Medical History Te
rm:pituitary tumo
rInitial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0906116
Page 259 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/20
16
Ongoing: YES
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906117
Page 260 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.q Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:55:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 03:26:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-21-2020 17:49:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-21-2020 17:49:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
benign pituitary adenomaTranscription Error
Oct-16-2020 00:15:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN: Ongoing
pituitary adenoma is
listed. Please clarify if
type of tumor is
known (adenoma?
non-functional or
hormone secreting
tumor?) and update
the term accordingly.
Oct-15-2020 16:11:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Candidate GPDCLIN: Ongoing
pituitary adenoma is
listed. Please clarify if
type of tumor is
known (adenoma?
non-functional or
hormone secreting
tumor?) and update
the term accordingly.
Aug-27-2020 09:55:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
pituitary tumorInitial Entry
1.q Start Date:
Date Location User Value Reason
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906118
Page 261 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-27-2020 09:55:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.q Ongoing:
Date Location User Value Reason
Sep-07-2020 21:07:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-04-2020 12:37:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered This event is
ongoing.
Sep-02-2020 18:15:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: There is a
Hx pituitary tumor
but there is no stop
date, is this ongoing
Aug-27-2020 09:55:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.r
Date Location User Value Reason
Oct-30-2020 08:33:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:18
Medical History
Term:Benign enlarged p
rostate
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/20
17New Information
Aug-27-2020 09:55:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:18
Medical History T
erm:enlarged prostat
e
Start Date: UNK/UNK/201
5Initial Entry
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906119
Page 262 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/2
017
1.r Line/MH Number:
Date Location User Value Reason
Aug-27-2020 09:55:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-30-2020 08:50:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae3e5d\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906120
Page 263 of 383
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391038 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-30-2020 08:33:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-30-2020 08:33:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Benign enlarged prostateNew Information
Oct-26-2020 11:38:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN: enlarge
prostate was resected
in 2017. Please
clarify if malignancy
was detected and
consider updating the
medical term or
adding a separate
medical term if
applicable.
Aug-27-2020 09:55:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
enlarged prostateInitial Entry
1.r Start Date:
Date Location User Value Reason
Aug-27-2020 09:55:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.r Ongoing:
Date Location User Value Reason
Aug-27-2020 09:55:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/
…[truncated]