125742 S1 M5 CRF c4591001 1019 10191010

Document text

Page 1 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895053
Page 2 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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/11/2020
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895054
Page 3 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10191010]
2.Birth Date: /1940
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895055
Page 4 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895056
Page 5 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Inclusion Criteria Not Met
1.aDescription of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895057
Page 6 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895058
Page 7 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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:[Cataracts - bilateral]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myopia - bilateral]
Start Date: UNK/UNK/1984
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Presbyopia]
Start Date: UNK/UNK/1984
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tonsillitis]
Start Date: UNK/UNK/1961
Ongoing: NO
End Date:
UNK/UNK/1961
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895059
Page 8 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[nasal polyps]
Start Date: May/UNK/2018
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dry mouth]
Start Date: UNK/UNK/2012
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pneumonia]
Start Date: Mar/UNK/2009
Ongoing: NO
End Date:
Mar/UNK/2009
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Obstructive Pulmonary Disease]
Start Date: UNK/UNK/1984
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sleep apnea]
Start Date: UNK/UNK/1989
Ongoing: YES
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895060
Page 9 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CPAP]
Start Date: UNK/UNK/1989
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bronchitis]
Start Date: Nov/12/2010
Ongoing: NO
End Date:
Nov/24/2010
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2004
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/1994
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Heart murmur]
Start Date: UNK/UNK/2004
Ongoing: YES
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895061
Page 10 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Peripheral Vascular Disease]
Start Date: May/UNK/2018
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[External hemorrhoids]
Start Date: UNK/UNK/2010
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anal fistula]
Start Date: UNK/UNK/1981
Ongoing: NO
End Date:
UNK/UNK/1981
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: UNK/UNK/1985
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Urinary incontinence]
Start Date: UNK/UNK/2002
Ongoing: YES
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895062
Page 11 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic kidney disease stage III]
Start Date: Apr/25/2018
Ongoing: YES
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Endometriosis]
Start Date: UNK/UNK/1960
Ongoing: NO
End Date:
UNK/UNK/1980
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Uterine lesion - benign]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2006
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: UNK/UNK/2014
Ongoing: YES
1 xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tension headaches]
Start Date: UNK/UNK/1993
Ongoing: YES
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895063
Page 12 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.yLine/MH Number: [25]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Carpal tunnel syndrome, bilateral]
Start Date: UNK/UNK/1996
Ongoing: NO
End Date:
UNK/UNK/1996
1.zLine/MH Number: [26]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Familial tremors]
Start Date: UNK/UNK/1974
Ongoing: YES
1.aaLine/MH Number: [27]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetic neuropathy bilateral hands]
Start Date: UNK/UNK/2000
Ongoing: YES
1.abLine/MH Number: [28]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetic neuropathy, bilateral lower extremities]
Start Date: UNK/UNK/2000
Ongoing: YES
1.acLine/MH Number: [29]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis, bilateral hands and knees]
Start Date: UNK/UNK/1997
Ongoing: YES
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895064
Page 13 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.adLine/MH Number: [30]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gout]
Start Date: UNK/UNK/1998
Ongoing: YES
1.aeLine/MH Number: [31]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteopenia]
Start Date: UNK/UNK/2012
Ongoing: YES
1.afLine/MH Number: [32]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoporosis]
Start Date: UNK/UNK/2016
Ongoing: YES
1.agLine/MH Number: [33]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fibromyalgia]
Start Date: Apr/UNK/2014
Ongoing: YES
1.ahLine/MH Number: [34]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fracture L. 5th toe]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895065
Page 14 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.aiLine/MH Number: [35]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fracture, right foot]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
1.ajLine/MH Number: [36]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral leg cramps]
Start Date: Apr/UNK/2018
Ongoing: YES
1.akLine/MH Number: [37]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurrent joint pain, neck, shoulders, ankles, elbows, hips, knees, wrists]
Start Date: UNK/UNK/1980
Ongoing: YES
1.alLine/MH Number: [38]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurrent back pain - lumbar]
Start Date: UNK/UNK/2004
Ongoing: YES
1.amLine/MH Number: [39]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fracture, right shoulder]
Start Date: Jul/UNK/2010
Ongoing: NO
End Date:
Jul/UNK/2010
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895066
Page 15 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.anLine/MH Number: [40]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Shoulder implant, right - insertion]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.aoLine/MH Number: [41]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Shoulder implant removal, right]
Start Date: Apr/UNK/2014
Ongoing: NO
End Date:
Apr/UNK/2014
1.apLine/MH Number: [42]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Shoulder implant infection, right]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1.aqLine/MH Number: [43]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tendonitis, left wrist]
Start Date: Jan/UNK/2006
Ongoing: NO
End Date:
Jan/UNK/2006
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895067
Page 16 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.arLine/MH Number: [44]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cyst, right ankle, benign]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
Jul/UNK/2010
1.asLine/MH Number: [45]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tennis elbow]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1999
1.atLine/MH Number: [46]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Stress fracture, right ankle]
Start Date: Aug/UNK/2010
Ongoing: NO
End Date:
Oct/5/2010
1.auLine/MH Number: [47]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2001
Ongoing: YES
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895068
Page 17 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.avLine/MH Number: [48]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: UNK/UNK/2001
Ongoing: YES
1.awLine/MH Number: [49]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetes mellitus type 2]
Start Date: UNK/UNK/2002
Ongoing: YES
1.axLine/MH Number: [50]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: UNK/UNK/2004
Ongoing: YES
1.ayLine/MH Number: [51]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Iron deficiency anemia]
Start Date: Sep/UNK/2010
Ongoing: NO
End Date:
Jul/31/2020
1.azLine/MH Number: [52]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Psoriasis]
Start Date: UNK/UNK/2002
Ongoing: YES
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895069
Page 18 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.baLine/MH Number: [53]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Rosacea]
Start Date: Nov/26/2001
Ongoing: YES
1.bbLine/MH Number: [54]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left rotator cuff tear]
Start Date: Jan/UNK/2018
Ongoing: NO
End Date:
Mar/1/2018
1.bcLine/MH Number: [55]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left fourth trigger finger]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1999
1.bdLine/MH Number: [56]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic rhinitis]
Start Date: UNK/UNK/1972
Ongoing: YES
1.beLine/MH Number: [57]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Drug allergy - penicillin]
Start Date: UNK/UNK/1950
Ongoing: YES
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895070
Page 19 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.bfLine/MH Number: [58]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Drug allergy - macrodantin]
Start Date: UNK/UNK/1950
Ongoing: YES
1.bgLine/MH Number: [59]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tonsillectomy]
Start Date: UNK/UNK/1961
Ongoing: NO
End Date:
UNK/UNK/1961
1.bhLine/MH Number: [60]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anal fistulectomy]
Start Date: UNK/UNK/1981
Ongoing: NO
End Date:
UNK/UNK/1981
1.biLine/MH Number: [61]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Arthroscopy left knee]
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/1980
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895071
Page 20 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.bjLine/MH Number: [62]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cholecystectomy]
Start Date: UNK/UNK/1994
Ongoing: NO
End Date:
UNK/UNK/1994
1.bkLine/MH Number: [63]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Carpal tunnel release surgery, bilateral]
Start Date: UNK/UNK/1996
Ongoing: NO
End Date:
UNK/UNK/1996
1.blLine/MH Number: [64]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Trigger release surgery, left fourth finger]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1999
1.bmLine/MH Number: [65]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Excision, uterine lesion]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895072
Page 21 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.bnLine/MH Number: [66]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left wrist tendonitis repair]
Start Date: Jan/UNK/2006
Ongoing: NO
End Date:
Jan/UNK/2006
1.boLine/MH Number: [67]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left knee arthroplasty]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007
1.bpLine/MH Number: [68]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cyst excision, right ankle]
Start Date: Jul/UNK/2010
Ongoing: NO
End Date:
Jul/UNK/2010
1.bqLine/MH Number: [69]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left rotator cuff repair surgery]
Start Date: Mar/1/2018
Ongoing: NO
End Date:
Mar/1/2018
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895073
Page 22 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.brLine/MH Number: [70]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chest Pain]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bsLine/MH Number: [71]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[atrial fibrillation]
Start Date: Nov/1/2017
Ongoing: YES
1.btLine/MH Number: [72]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[implantable loop recorder]
Start Date: Nov/1/2017
Ongoing: YES
1.buLine/MH Number: [73]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[mitral valve regurgitation]
Start Date: UNK/UNK/2005
Ongoing: YES
1.bvLine/MH Number: [74]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[edema- bilateral lower extremities]
Start Date: Apr/25/2018
Ongoing: YES
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895074
Page 23 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.bwLine/MH Number: [75]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cholelithiasis]
Start Date: UNK/UNK/1994
Ongoing: NO
End Date:
UNK/UNK/1994
1.bxLine/MH Number: [76]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[heartburn]
Start Date: UNK/UNK/1990
Ongoing: YES
1.byLine/MH Number: [77]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[duodenal ulcer]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/2000
1.bzLine/MH Number: [78]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[esophageal ulcer]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/2000
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895075
Page 24 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.caLine/MH Number: [79]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chronic constipation]
Start Date: Apr/UNK/2010
Ongoing: YES
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895076
Page 25 of 707
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/11/2020
2.Weight: [189.7]
3.Unit: LB
4.Height: [62.5]
5.Unit: in
6.Body Mass Index: [34.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: EAR
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895077
Page 26 of 707
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/11/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895078
Page 27 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/11/2020
2.Randomization Number: [225292]
3.Randomization Group: [ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895079
Page 28 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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/11/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM86C1]
5.bSample ID [BM86C2]
5.cSample ID [BM86C3]
5.dSample ID [BPRM37]
5.eSample ID [BPRM38]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895080
Page 29 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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/11/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM85ZL]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895081
Page 30 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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/11/2020 10:15
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
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895082
Page 31 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895083
Page 32 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895084
Page 33 of 707
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/12/2020
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895085
Page 34 of 707
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/12/2020
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895086
Page 35 of 707
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: EAR
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895087
Page 36 of 707
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/1/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895088
Page 37 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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/1/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8649]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895089
Page 38 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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/1/2020 08:18
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
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895090
Page 39 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895091
Page 40 of 707
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895092
Page 41 of 707
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895093
Page 42 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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/6/2020
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 [BP98K5]
5.bSample ID [BRTLKK]
5.cSample ID [BRTLKL]
5.dSample ID [BRTLKM]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895094
Page 43 of 707
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895095
Page 44 of 707
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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 [ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895096
Page 45 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895097
Page 46 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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 [ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895098
Page 47 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895099
Page 48 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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 [ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895100
Page 49 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895101
Page 50 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Applicable
//Comments
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Applicable Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Applicable Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Applicable Comments
4.dSymptoms: CHILLS
Was symptom present? Not Applicable Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Applicable Comments
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Applicable Comments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895102
Page 51 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Applicable Comments
4.hSymptoms: DIARRHEA
Was symptom present? Not Applicable Comments
4.iSymptoms: VOMITING
Was symptom present? Not Applicable Comments
Symptoms - Other
5.Symptoms - Other Text: Not Applicable
[ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895103
Page 52 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Type Form Instance
 1.Not Applicable  Not Applicab
le Not Applicable  Not Applicable  Not Applicab
le Repeating
Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895104
Page 53 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895105
Page 54 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895106
Page 55 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895107
Page 56 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895108
Page 57 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Aug/27/2020  NO
Discharge Date:
Aug/29/2020
 Repeating Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895109
Page 58 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS Comments
2.Hospitalization Term: HOSPITAL Comments
3.Admission Date: Aug/27/2020 Comments
4.Ongoing? NO
Discharge Date:
Aug/29/2020Comments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895110
Page 59 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895111
Page 60 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895112
Page 61 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?Not Applicable Comments
3.Toxicity Grade: Not Applicable Comments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895113
Page 62 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895114
Page 63 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895115
Page 64 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category fo
r Lab TestVendor NameCollecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.CLINICAL
CHEMISTR
Y Methodist and Children's Hospital,77
00 Floyd Curl Dr.,San Antonio, Texa
s 78229 Aug/27/
2020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
329  Not Ap
plicable
  
30  Not Ap
plicable
 23 
28  Not Ap
plicable
 22 
35  Not Ap
plicable
 98 
21  Not Ap
plicable
 0.6 
47  Not Ap
plicable
 10 
48  Not Ap
plicable
 1.0
1 Repeating
Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895116
Page 65 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY Comments
2.Laboratory Name and Address [Methodist and Children's Hospital,7700 Floyd Curl Dr.,San Antonio,
Texas 78229]Comments
3.Collection Date: Aug/27/2020 Comments
4.Specimen Type: BLOOD Comments
Lab Result
5.aSponsor ID: [329] Comments
Test: C Reactive Protein_PX329
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: [30] Comments
Test: Alanine Aminotransferase_PX30
Result: [23] Comments
Not Done: Comments
LNMT Low
[13]
High
[61]
Unit
U/LComments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895117
Page 66 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSponsor ID: [28] Comments
Test: Aspartate Aminotransferase_PX28
Result: [22] Comments
Not Done: Comments
LNMT Low
[15]
High
[37]
Unit
U/LComments
5.dSponsor ID: [35] Comments
Test: Alkaline Phosphatase_PX35
Result: [98] Comments
Not Done: Comments
LNMT Low
[45]
High
[117]
Unit
U/LComments
5.eSponsor ID: [21] Comments
Test: Bilirubin_PX21
Result: [0.6] Comments
Not Done: Comments
LNMT Low
[0.2]
High
[1.0]
Unit
mg/dLComments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895118
Page 67 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: [47] Comments
Test: Blood Urea Nitrogen_PX47
Result: [10] Comments
Not Done: Comments
LNMT Low
[7]
High
[18]
Unit
mg/dLComments
5.gSponsor ID: [48] Comments
Test: Creatinine_PX48
Result: [1.01] Comments
Not Done: Comments
LNMT Low
[0.6]
High
[1.3]
Unit
mg/dLComments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895119
Page 68 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category f
or Lab Tes
tVendor Name (DERIVED)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.HEMATO
LOGY Methodist and Children's Hospitals,77
00 Floyd Curl Dr.,San Antonio, Texas
78229 Aug/27/
2020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
1  Not Ap
plicable
 12.
6 
2  Not Ap
plicable
 37.
5 
3  Not Ap
plicable
  
5  Not Ap
plicable
 322
 
7  Not Ap
plicable
  
608  Not Ap
plicable
 5.3 
609  Not Ap
plicable
 0.8 
612  Not Ap
plicable
 0.8 
610  Not Ap
plicable
 0.1 
611  Not Ap
plicable
 2.6 Repeating
Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895120
Page 69 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY Comments
2.Laboratory Name and Address [Methodist and Children's Hospitals,7700 Floyd Curl Dr.,San
Antonio, Texas 78229]Comments
3.Collection Date: Aug/27/2020 Comments
4.Specimen Type: BLOOD Comments
Lab Result
5.aSponsor ID: [1] Comments
Test: Hemoglobin_PX1
Result: [12.6] Comments
Not Done: Comments
LNMT Low
[12.0]
High
[16.0]
Unit
g/dLComments
5.bSponsor ID: [2] Comments
Test: Hematocrit_PX2
Result: [37.5] Comments
Not Done: Comments
LNMT Low
[36.0]
High
[46.0]
Unit
%Comments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895121
Page 70 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSponsor ID: [3] Comments
Test: Erythrocytes_PX3
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
5.dSponsor ID: [5] Comments
Test: Platelets_PX5
Result: [322] Comments
Not Done: Comments
LNMT Low
[150]
High
[400]
Unit
/uLComments
5.eSponsor ID: [7] Comments
Test: Leukocytes_PX7
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895122
Page 71 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: [608] Comments
Test: Neutrophils_PX608
Result: [5.3] Comments
Not Done: Comments
LNMT Low
[1.5]
High
[7.8]
Unit
/uLComments
5.gSponsor ID: [609] Comments
Test: Eosinophils_PX609
Result: [0.8] Comments
Not Done: Comments
LNMT Low
[0.0]
High
[6.0]
Unit
/uLComments
5.hSponsor ID: [612] Comments
Test: Monocytes_PX612
Result: [0.8] Comments
Not Done: Comments
LNMT Low
[0.2]
High
[1.0]
Unit
/uLComments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895123
Page 72 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.iSponsor ID: [610] Comments
Test: Basophils_PX610
Result: [0.1] Comments
Not Done: Comments
LNMT Low
[0.0]
High
[0.1]
Unit
/uLComments
5.jSponsor ID: [611] Comments
Test: Lymphocytes_PX611
Result: [2.6] Comments
Not Done: Comments
LNMT Low
[0.8]
High
[3.4]
Unit
/uLComments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895124
Page 73 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1. DELETED Aug/27/2020 Record Identifier: Systolic: Diastolic:
Not Applicable  187  74 Repeating Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895125
Page 74 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 2. DELETED Aug/27/2020 Record Identifier: Systolic: Diastolic:
1  162  73 Repeating Pages
 3. DELETED Aug/27/2020 Record Identifier: Systolic: Diastolic:
1  178  76 Repeating Pages
 4. DELETED  Record Identifier: Systolic: Diastolic:
1     Repeating Pages
 5. DELETED Aug/27/2020 Record Identifier: Systolic: Diastolic:
1  175  78 Repeating Pages
 6. DELETED Aug/27/2020 Record Identifier: Systolic: Diastolic:
1  177  109 Repeating Pages
 7. Aug/27/2020 Record Identifier: Systolic: Diastolic:
1  136  48 Repeating Pages
 8. DELETED Aug/27/2020 Record Identifier: Systolic: Diastolic:
1  202  81 Repeating Pages
 9. DELETED Aug/27/2020 Record Identifier: Systolic: Diastolic:
1  192  78 Repeating Pages
 10. DELETED Aug/27/2020 Record Identifier: Systolic: Diastolic:
1  169  72 Repeating Pages
 11. DELETED Aug/28/2020 Record Identifier: Systolic: Diastolic:
1  146  67 Repeating Pages
 12. DELETED Aug/28/2020 Record Identifier: Systolic: Diastolic:
1  151  96 Repeating Pages
 13. DELETED Aug/28/2020 Record Identifier: Systolic: Diastolic:
1  123  50 Repeating Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895126
Page 75 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 14. DELETED Aug/28/2020 Record Identifier: Systolic: Diastolic:
1  149  71 Repeating Pages
 15. Aug/28/2020 Record Identifier: Systolic: Diastolic:
1  122  63 Repeating Pages
 16. Aug/29/2020 Record Identifier: Systolic: Diastolic:
1  138  69 Repeating Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895127
Page 76 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020 Comments
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [187] Comments
Diastolic: [74] Comments
Respiratory Rate in
respirations/minute:[20] Comments
Heart Rate in beats/minute: [69] Comments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895128
Page 77 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [162]
Diastolic: [73]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [83]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895129
Page 78 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [178]
Diastolic: [76]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [77]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895130
Page 79 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Incomplete, Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: //
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895131
Page 80 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [175]
Diastolic: [78]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [75]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895132
Page 81 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [177]
Diastolic: [109]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [75]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895133
Page 82 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [136]
Diastolic: [48]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [66]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895134
Page 83 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [202]
Diastolic: [81]
Respiratory Rate in
respirations/minute:[22]
Heart Rate in beats/minute: [69]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895135
Page 84 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [192]
Diastolic: [78]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [72]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895136
Page 85 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [169]
Diastolic: [72]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [72]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895137
Page 86 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [146]
Diastolic: [67]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [126]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895138
Page 87 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [151]
Diastolic: [96]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [72]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895139
Page 88 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [123]
Diastolic: [50]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [78]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895140
Page 89 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [149]
Diastolic: [71]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [70]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895141
Page 90 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [122]
Diastolic: [63]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [73]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895142
Page 91 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [138] Comments
Diastolic: [69] Comments
Respiratory Rate in
respirations/minute:[18] Comments
Heart Rate in beats/minute: [56] Comments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895143
Page 92 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1. DELETED Aug/27/2020 Record Identifier: Oxygen Saturation
Unknown  100.0 Repeating Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895144
Page 93 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 2. DELETED Aug/27/2020 Record Identifier: Oxygen Saturation
1  98.0 Repeating Pages
 3. DELETED Aug/27/2020 Record Identifier: Oxygen Saturation
1  100.0 Repeating Pages
 4. DELETED Aug/27/2020 Record Identifier: Oxygen Saturation
1  99.0 Repeating Pages
 5. DELETED Aug/27/2020 Record Identifier: Oxygen Saturation
1  99.0 Repeating Pages
 6. DELETED Aug/27/2020 Record Identifier: Oxygen Saturation
1  99.0 Repeating Pages
 7. Aug/27/2020 Record Identifier: Oxygen Saturation
1  95.0 Repeating Pages
 8. DELETED Aug/27/2020 Record Identifier: Oxygen Saturation
1  100.0 Repeating Pages
 9. DELETED Aug/28/2020 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
 10. DELETED Aug/28/2020 Record Identifier: Oxygen Saturation
1  99.0 Repeating Pages
 11. DELETED Aug/28/2020 Record Identifier: Oxygen Saturation
1  99.0 Repeating Pages
 12. DELETED Aug/28/2020 Record Identifier: Oxygen Saturation
1  99.0 Repeating Pages
 13. Aug/28/2020 Record Identifier: Oxygen Saturation
1  96.0 Repeating Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895145
Page 94 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 14. Aug/29/2020 Record Identifier: Oxygen Saturation
1  93.0 Repeating Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895146
Page 95 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Deleted
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020 Comments
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [100.0] Comments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895147
Page 96 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895148
Page 97 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [100.0]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895149
Page 98 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895150
Page 99 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895151
Page 100 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895152
Page 101 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [95.0]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895153
Page 102 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [100.0]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895154
Page 103 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895155
Page 104 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895156
Page 105 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895157
Page 106 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895158
Page 107 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [96.0]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895159
Page 108 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Aug/29/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [93.0]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895160
Page 109 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895161
Page 110 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895162
Page 111 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895163
Page 112 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895164
Page 113 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895165
Page 114 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895166
Page 115 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895167
Page 116 of 707
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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 [ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895168
Page 117 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895169
Page 118 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895170
Page 119 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895171
Page 120 of 707
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Dec/2/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: LOST TO FOLLOW-UP
4.Specify Status: [lost to follow up]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895172
Page 121 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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:
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895173
Page 122 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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 [ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895174
Page 123 of 707
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Diarrhea  Aug/17/2020 00:00
 NO
End Date Time:
Aug/27/2020 00:00
 Repeating
Pages
 2.ADVERSE EV
ENT 2  Diarrhea  Aug/27/2020 UNK
:UNK NO
End Date Time:
Aug/29/2020 UNK:UNK
 Repeating
Pages
 3.ADVERSE EV
ENT 3  Mental State Status
Change Oct/2/2020 UNK:
UNK NO
End Date Time:
Oct/2/2020 UNK:UNK
 Repeating
Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895175
Page 124 of 707
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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)[Diarrhea]
4.Start Date Time: Aug/17/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/27/2020 00:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Pre-Existing conditions]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895176
Page 125 of 707
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895177
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***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2] Comments
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Diarrhea] Comments
4.Start Date Time: Aug/27/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/29/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
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?
YES
Other medically important serious event
YES
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
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(b) (4)
FDA-CBER-2021-5683-0895178
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020339743]
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(b) (4)
FDA-CBER-2021-5683-0895179
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***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Mental State Status Change]
4.Start Date Time: Oct/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/2/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
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(b) (4)
FDA-CBER-2021-5683-0895180
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?: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[ ]
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(b) (4)
FDA-CBER-2021-5683-0895181
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0895182
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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[ ]
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(b) (4)
FDA-CBER-2021-5683-0895183
Page 132 of 707
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895184
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
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(b) (4)
FDA-CBER-2021-5683-0895185
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0895186
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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?
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(b) (4)
FDA-CBER-2021-5683-0895187
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0895188
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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?
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895189
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0895190
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
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(b) (4)
FDA-CBER-2021-5683-0895191
Page 140 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895192
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***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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:
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(b) (4)
FDA-CBER-2021-5683-0895193
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***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
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(b) (4)
FDA-CBER-2021-5683-0895194
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***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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?
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895195
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***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895196
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***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895197
Page 146 of 707
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895198
Page 147 of 707
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895199
Page 148 of 707
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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 [ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895200
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***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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 [ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895201
Page 150 of 707
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895202
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***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895203
Page 152 of 707
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895204
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***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895205
Page 154 of 707
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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: [ ]
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895206
Page 155 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Dec/2/2020
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895207
Page 156 of 707
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 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
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895208
Page 157 of 707
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895209
Page 158 of 707
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-18-2020 07:58:22 (UTC-06:00) Central
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Comments
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
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Subject No: 10191010 Subject Initials: ---
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Comments
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
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ItemDate User Comment
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Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
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Subject No: 10191010 Subject Initials: ---
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ItemDate User Comment
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Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
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4.aSep-22-2020 07:17:01 (UTC-06:00) Central Time
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Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.bSep-22-2020 07:17:01 (UTC-06:00) Central Time
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Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
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090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
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Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
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Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
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Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.eSep-22-2020 07:17:01 (UTC-06:00) Central Time
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090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
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(b) (4)
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Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4 fSep-22-2020 07:17:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
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Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
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Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.gSep-22-2020 07:17:01 (UTC-06:00) Central Time
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090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
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Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4 hSep-22-2020 07:17:01 (UTC-06:00) Central Time
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090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
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Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
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Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
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Subject No: 10191010 Subject Initials: ---
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Time (US & Canada)Not Applicable
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10191010 Subject Initials: ---
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Back to Form
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10191010 Subject Initials: ---
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Back to Form
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10191010 Subject Initials: ---
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Back to Form
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Subject No: 10191010 Subject Initials: ---
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Back to Form
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Subject No: 10191010 Subject Initials: ---
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Back to Form
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Subject No: 10191010 Subject Initials: ---
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Back to Form
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Subject No: 10191010 Subject Initials: ---
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Back to Form
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Subject No: 10191010 Subject Initials: ---
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Subject No: 10191010 Subject Initials: ---
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Back to Form
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Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
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Subject No: 10191010 Subject Initials: ---
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3Sep-21-2020 15:40:08 (UTC-06:00) Central Time
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Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
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Subject No: 10191010 Subject Initials: ---
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Back to Form
ItemDate User Comment
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
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Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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2Sep-21-2020 15:40:19 (UTC-06:00) Central Time
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3Sep-21-2020 15:40:19 (UTC-06:00) Central Time
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Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
4Sep-21-2020 15:40:19 (UTC-06:00) Central Time
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-07-2020 10:18:25 (UTC-06:00) Central
Time (US & Canada)
FormSep-21-2020 15:41:08 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895244
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-07-2020 10:18:25 (UTC-06:00) Central Time
(US & Canada)
1Sep-21-2020 15:41:08 (UTC-06:00) Central Time
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090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895245
Page 194 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: HOSPITALIZATION DETAILS - Comments
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-07-2020 10:18:25 (UTC-06:00) Central Time
(US & Canada)
2Sep-21-2020 15:41:08 (UTC-06:00) Central Time
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090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895246
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-07-2020 10:18:25 (UTC-06:00) Central Time
(US & Canada)
3Sep-21-2020 15:41:08 (UTC-06:00) Central Time
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090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895247
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-07-2020 10:18:25 (UTC-06:00) Central Time
(US & Canada)
4Sep-21-2020 15:41:08 (UTC-06:00) Central Time
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090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895248
Page 197 of 707
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-21-2020 15:41:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895249
Page 198 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: RESPIRATORY TREATMENT - Comments
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-21-2020 15:41:17 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895250
Page 199 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-21-2020 15:41:17 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895251
Page 200 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-21-2020 15:41:17 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895252
Page 201 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-21-2020 15:41:17 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895253
Page 202 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-21-2020 15:41:17 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895254
Page 203 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Sep-21-2020 15:41:17 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895255
Page 204 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-24-2020 09:44:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormOct-22-2020 10:21:05 (UTC-06:00) Central
Time (US & Canada)
FormSep-21-2020 15:41:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895256
Page 205 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-24-2020 09:44:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Oct-22-2020 10:21:05 (UTC-06:00) Central Time
(US & Canada)
1Sep-21-2020 15:41:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895257
Page 206 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-24-2020 09:44:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Oct-22-2020 10:21:05 (UTC-06:00) Central Time
(US & Canada)
2Sep-21-2020 15:41:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895258
Page 207 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-24-2020 09:44:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Oct-22-2020 10:21:05 (UTC-06:00) Central Time
(US & Canada)
3Sep-21-2020 15:41:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895259
Page 208 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-21-2020 15:41:29 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895260
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-21-2020 15:41:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895261
Page 210 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-21-2020 15:41:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895262
Page 211 of 707
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-21-2020 15:41:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895263
Page 212 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-21-2020 15:41:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895264
Page 213 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
FormSep-21-2020 15:41:49 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895265
Page 214 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
1Sep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895266
Page 215 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
2Sep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895267
Page 216 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
3Sep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895268
Page 217 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
4Sep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895269
Page 218 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.aSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895270
Page 219 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.aSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895271
Page 220 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.aSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895272
Page 221 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.aSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895273
Page 222 of 707
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.bSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895274
Page 223 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.bSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895275
Page 224 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.bSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895276
Page 225 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.bSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895277
Page 226 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.cSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895278
Page 227 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.cSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895279
Page 228 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.cSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895280
Page 229 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.cSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895281
Page 230 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.dSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895282
Page 231 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.dSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895283
Page 232 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.dSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895284
Page 233 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.dSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895285
Page 234 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.eSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895286
Page 235 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.eSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895287
Page 236 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.eSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895288
Page 237 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.eSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895289
Page 238 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5 fSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895290
Page 239 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5 fSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895291
Page 240 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5 fSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895292
Page 241 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5 fSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895293
Page 242 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.gSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895294
Page 243 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.gSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895295
Page 244 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.gSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895296
Page 245 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-11-2020 08:13:58 (UTC-06:00) Central
Time (US & Canada)
5.gSep-21-2020 15:41:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895297
Page 246 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
FormSep-21-2020 15:42:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895298
Page 247 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
1Sep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895299
Page 248 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
2Sep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
3Sep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895301
Page 250 of 707
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
4Sep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895302
Page 251 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.aSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895303
Page 252 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.aSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895304
Page 253 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.aSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895305
Page 254 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.aSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895306
Page 255 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.bSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895307
Page 256 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.bSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895308
Page 257 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.bSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895309
Page 258 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.bSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895310
Page 259 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.cSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895311
Page 260 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.cSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895312
Page 261 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.cSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895313
Page 262 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.cSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895314
Page 263 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.dSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895315
Page 264 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.dSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895316
Page 265 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.dSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895317
Page 266 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.dSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895318
Page 267 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.eSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895319
Page 268 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.eSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895320
Page 269 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.eSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895321
Page 270 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5.eSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895322
Page 271 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5 fSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895323
Page 272 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5 fSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895324
Page 273 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5 fSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895325
Page 274 of 707
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191010 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fNov-11-2020 10:20:35 (UTC-06:00) Central
Time (US & Canada)
5 fSep-21-2020 15:42:11 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e27\Final\Final On: 01-Apr-2021
…[truncated]