Document text
Page 1 of 402
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795270
Page 2 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/15/2020
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795271
Page 3 of 402
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Demography
1.Subject ID [11171121]
2.Birth Date: /1986
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:
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795272
Page 4 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit Not Applicable Comments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795273
Page 5 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795274
Page 6 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: Not Applicable
[ ]Comments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795275
Page 7 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Demerol induced anaphylaxis]
Start Date: UNK/UNK/1991
Ongoing: NO
End Date:
UNK/UNK/1991
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy, Demerol]
Start Date: UNK/UNK/1991
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Radial head fracture, Left, non-displaced]
Start Date: Jul/22/2020
Ongoing: YES
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795276
Page 8 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pain, elbow, left]
Start Date: Jul/25/2020
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: Jan/UNK/2020
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[C-Section]
Start Date: Oct/15/2016
Ongoing: NO
End Date:
Oct/15/2016
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hip scope, right]
Start Date: Dec/UNK/2005
Ongoing: NO
End Date:
Dec/UNK/2005
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795277
Page 9 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hip fracture, right]
Start Date: Dec/UNK/2005
Ongoing: NO
End Date:
Dec/UNK/2005
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Elbow, left, displaced fracture]
Start Date: UNK/UNK/1991
Ongoing: NO
End Date:
UNK/UNK/1991
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[elbow repair, left]
Start Date: UNK/UNK/1991
Ongoing: NO
End Date:
UNK/UNK/1991
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendicitis]
Start Date: UNK/UNK/1996
Ongoing: NO
End Date:
UNK/UNK/1996
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795278
Page 10 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendectomy]
Start Date: UNK/UNK/1996
Ongoing: NO
End Date:
UNK/UNK/1996
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tooth extraction, wisdom]
Start Date: UNK/UNK/2002
Ongoing: NO
End Date:
UNK/UNK/2002
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pain, tooth]
Start Date: UNK/UNK/2002
Ongoing: NO
End Date:
UNK/UNK/2002
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy, seasonal]
Start Date: UNK/UNK/2001
Ongoing: YES
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795279
Page 11 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myopia, bilateral]
Start Date: UNK/UNK/1993
Ongoing: YES
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sinusitis, chronic]
Start Date: UNK/UNK/2005
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[pneumonia]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[pneumonia]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Alcohol use, 2/week]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795280
Page 12 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
2.Weight: [232.6]
3.Unit: LB
4.Height: [67.8]
5.Unit: in
6.Body Mass Index: [35.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795281
Page 13 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/15/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795282
Page 14 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/15/2020
2.Randomization Number: [88144]
3.Randomization Group: [ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795283
Page 15 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
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.aSample ID [BPRV3J]
5.bSample ID [BPRV3K]
5.cSample ID [BM8YKX]
5.dSample ID [BM8YKY]
5.eSample ID [BM8YKZ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795284
Page 16 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
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.aSample ID [BM8YJ1]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795285
Page 17 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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/15/2020 10:06
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795286
Page 18 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795287
Page 19 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795288
Page 20 of 402
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vital Signs
1.Date: Oct/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795289
Page 21 of 402
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/6/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795290
Page 22 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
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 [BRJ89L]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795291
Page 23 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/6/2020 17:09
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795292
Page 24 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795293
Page 25 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/5/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP58YY]
5.bSample ID [BP58YZ]
5.cSample ID [BP58Z0]
5.dSample ID [BRSRT0]
5.eSample ID [BRSRT1]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795294
Page 26 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/23/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795295
Page 27 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/23/2020
2.Date of First Symptom Started: Nov/16/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/11/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795296
Page 28 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.aSymptoms - Other Text: [RHINORRHEA]
5.bSymptoms - Other Text: [HEADACHE]
5.cSymptoms - Other Text: [FATIGUE]
5.dSymptoms - Other Text: [NASAL CONGESTION]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795297
Page 29 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Date of Co
llectionSpecimen Typ
eSpecimen Collect
ion LocationAssay Code and Description Device TypeForm Instan
ce
1.Nov/22/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795298
Page 30 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/22/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [CLIA ACCREDITED FACILITY]
9.Trade Name Other, Specify: [CLIA CERTIFIED LAB]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795299
Page 31 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/22/2020
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 [CV05746]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795300
Page 32 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[TELEHEALTH VISIT, SEE SELF SWAB]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795301
Page 33 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795302
Page 34 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795303
Page 35 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795304
Page 36 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19 INFECTION]
Date of Diagnosis:
Nov/22/2020
3.Toxicity Grade: 3
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795305
Page 37 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795306
Page 38 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795307
Page 39 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined Id
entifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795308
Page 40 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795309
Page 41 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795310
Page 42 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795311
Page 43 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795312
Page 44 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest:Result
:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795313
Page 45 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795314
Page 46 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795315
Page 47 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795316
Page 48 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795317
Page 49 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795318
Page 50 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795319
Page 51 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795320
Page 52 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795321
Page 53 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795322
Page 54 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795323
Page 55 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795324
Page 56 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795325
Page 57 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Don
e Repeating
Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795326
Page 58 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795327
Page 59 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795328
Page 60 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795329
Page 61 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/22/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: Not Applicable Comments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795330
Page 62 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/22/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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.aSample ID [ ]
5.bSample ID [ ]
5.cSample ID [ ]
5.dSample ID [ ]
5.eSample ID [ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795331
Page 63 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Jan/21/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795332
Page 64 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Jan/21/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRSRJK]
5.bSample ID [BRSRJL]
5.cSample ID [BP5907]
5.dSample ID [BP5908]
5.eSample ID [BP5909]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795333
Page 65 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795334
Page 66 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795335
Page 67 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795336
Page 68 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Unplanned Assessments
1.Assessments
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795337
Page 69 of 402
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
1.ADVERSE EVEN
T 1 ANGIOEDEM
A Oct/31/2020 08:
00 NO
End Date Time:
Nov/3/2020 UNK:UNK
Repeating
Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795338
Page 70 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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)[ANGIOEDEMA]
4.Start Date Time: Oct/31/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/3/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[CONMED REACTION, LISINOPRIL]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795339
Page 71 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795340
Page 72 of 402
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
1. Repeating
Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795341
Page 73 of 402
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795342
Page 74 of 402
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart Da
teForm Instanc
e
1.1 VACCINATIONS NO FLU VACCINE
Sep/1/20
20 Repeating
Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795343
Page 75 of 402
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[FLU VACCINE]
5.Date: Sep/1/2020
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795344
Page 76 of 402
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795345
Page 77 of 402
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795346
Page 78 of 402
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795347
Page 79 of 402
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795348
Page 80 of 402
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795349
Page 81 of 402
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795350
Page 82 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795351
Page 83 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795352
Page 84 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795353
Page 85 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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:
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795354
Page 86 of 402
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795355
Page 87 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795356
Page 88 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795357
Page 89 of 402
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795358
Page 90 of 402
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795359
Page 91 of 402
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795360
Page 92 of 402
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/11/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795361
Page 93 of 402
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795362
Page 94 of 402
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795363
Page 95 of 402
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795364
Page 96 of 402
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/18/2021
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795365
Page 97 of 402
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795366
Page 98 of 402
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/18/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795367
Page 99 of 402
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/18/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795368
Page 100 of 402
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/18/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRSRH9]
5.bSample ID [BRSRHB]
5.cSample ID [BRDFTS]
5.dSample ID [BRDFTT]
5.eSample ID [BRDFTV]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795369
Page 101 of 402
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/18/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP58ZT]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795370
Page 102 of 402
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/18/2021 09:58
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795371
Page 103 of 402
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795372
Page 104 of 402
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/8/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795373
Page 105 of 402
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6RV0]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795374
Page 106 of 402
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/8/2021 09:43
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795375
Page 107 of 402
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795376
Page 108 of 402
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795377
Page 109 of 402
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795378
Page 110 of 402
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795379
Page 111 of 402
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795380
Page 112 of 402
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795381
Page 113 of 402
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795382
Page 114 of 402
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/5/2020
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795383
Page 115 of 402
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795384
Page 116 of 402
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-10-2021 11:53:32 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795385
Page 117 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2Sep-18-2020 12:53:55 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795386
Page 118 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormSep-18-2020 12:54:23 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795387
Page 119 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Sep-18-2020 12:54:52 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795388
Page 120 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Sep-21-2020 12:25:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795389
Page 121 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Sep-21-2020 12:43:05 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795390
Page 122 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Nov-25-2020 11:05:58 (UTC-06:00) Central Time
(US & Canada)TELEHEALTH VISIT, SEE SELF SWAB
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795391
Page 123 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormNov-25-2020 11:06:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795392
Page 124 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Nov-25-2020 11:06:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795393
Page 125 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2Nov-25-2020 11:06:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795394
Page 126 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Nov-25-2020 11:06:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795395
Page 127 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Nov-25-2020 11:06:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795396
Page 128 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5Nov-25-2020 11:06:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795397
Page 129 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6Nov-25-2020 11:06:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795398
Page 130 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormNov-25-2020 11:08:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795399
Page 131 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Nov-25-2020 11:08:23 (UTC-06:00) Central Time
(US & Canada)Not Done
1Nov-25-2020 11:08:11 (UTC-06:00) Central Time
(US & Canada)
1Nov-25-2020 11:07:52 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795400
Page 132 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2Nov-25-2020 11:08:23 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795401
Page 133 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Nov-25-2020 11:08:23 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795402
Page 134 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Nov-25-2020 11:08:23 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795403
Page 135 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormNov-25-2020 11:08:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795404
Page 136 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Nov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795405
Page 137 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2Nov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795406
Page 138 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Nov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795407
Page 139 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Nov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795408
Page 140 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.aNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795409
Page 141 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.aNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795410
Page 142 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.aNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795411
Page 143 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.aNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795412
Page 144 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.bNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795413
Page 145 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.bNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795414
Page 146 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.bNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795415
Page 147 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.bNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795416
Page 148 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.cNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795417
Page 149 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.cNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795418
Page 150 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.cNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795419
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.cNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795420
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.dNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795421
Page 153 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.dNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795422
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.dNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795423
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.dNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795424
Page 156 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.eNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795425
Page 157 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.eNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795426
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.eNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795427
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.eNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795428
Page 160 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5 fNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795429
Page 161 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5 fNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795430
Page 162 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5 fNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795431
Page 163 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5 fNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795432
Page 164 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.gNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795433
Page 165 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.gNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795434
Page 166 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.gNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795435
Page 167 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.gNov-25-2020 11:08:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795436
Page 168 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormNov-25-2020 11:08:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795437
Page 169 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Nov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795438
Page 170 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2Nov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795439
Page 171 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Nov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795440
Page 172 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Nov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795441
Page 173 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.aNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795442
Page 174 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.aNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795443
Page 175 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.aNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795444
Page 176 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.aNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795445
Page 177 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.bNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795446
Page 178 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.bNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795447
Page 179 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.bNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795448
Page 180 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.bNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795449
Page 181 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.cNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795450
Page 182 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.cNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795451
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.cNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795452
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.cNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795453
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.dNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795454
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.dNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795455
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.dNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795456
Page 188 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.dNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795457
Page 189 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.eNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795458
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.eNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795459
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.eNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795460
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.eNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795461
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5 fNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795462
Page 194 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5 fNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795463
Page 195 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5 fNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795464
Page 196 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5 fNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795465
Page 197 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.gNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795466
Page 198 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.gNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795467
Page 199 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.gNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795468
Page 200 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.gNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795469
Page 201 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5 hNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795470
Page 202 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5 hNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795471
Page 203 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5 hNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795472
Page 204 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5 hNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795473
Page 205 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.iNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795474
Page 206 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.iNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795475
Page 207 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.iNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795476
Page 208 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.iNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795477
Page 209 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.jNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795478
Page 210 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.jNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795479
Page 211 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.jNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795480
Page 212 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.jNov-25-2020 11:08:58 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795481
Page 213 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormNov-25-2020 11:09:15 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795482
Page 214 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Nov-25-2020 11:09:15 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795483
Page 215 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2.aNov-25-2020 11:09:15 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795484
Page 216 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2.aNov-25-2020 11:09:15 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795485
Page 217 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2.aNov-25-2020 11:09:15 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795486
Page 218 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2.aNov-25-2020 11:09:15 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795487
Page 219 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormNov-25-2020 11:09:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795488
Page 220 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Nov-25-2020 11:09:30 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795489
Page 221 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2.aNov-25-2020 11:09:30 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795490
Page 222 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormNov-25-2020 11:09:45 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795491
Page 223 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Nov-25-2020 11:09:45 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795492
Page 224 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2Nov-25-2020 11:09:45 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795493
Page 225 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Nov-25-2020 11:09:45 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795494
Page 226 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormNov-25-2020 11:10:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795495
Page 227 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Nov-25-2020 11:10:03 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795496
Page 228 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2Nov-25-2020 11:10:03 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795497
Page 229 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Nov-25-2020 11:10:03 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795498
Page 230 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Nov-25-2020 11:10:03 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795499
Page 231 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5Nov-25-2020 11:10:03 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795500
Page 232 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6Nov-25-2020 11:10:03 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795501
Page 233 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormNov-25-2020 11:10:19 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795502
Page 234 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Nov-25-2020 11:10:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795503
Page 235 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2Nov-25-2020 11:10:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795504
Page 236 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Nov-25-2020 11:10:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795505
Page 237 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Nov-25-2020 11:10:19 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795506
Page 238 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: DATE OF VISIT - ILLNESS CONVALESCENT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Feb-19-2021 10:46:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795507
Page 239 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/22/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormFeb-19-2021 10:45:45 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795508
Page 240 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Feb-19-2021 10:45:45 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795509
Page 241 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2Feb-19-2021 10:45:45 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795510
Page 242 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Feb-19-2021 10:45:45 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795511
Page 243 of 402
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Feb-19-2021 10:45:45 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795512
Page 244 of 402
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormJan-22-2021 15:13:30 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795513
Page 245 of 402
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-10-2021 11:53:32 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-28-2020 21:28:42 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Dec-02-2020 13:13:31 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-25-2020 11:01:36 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-16-2020 16:26:02 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795514
Page 246 of 402
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-12-2020 13:05:03 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-09-2020 16:02:50 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795515
Page 247 of 402
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-16-2020 14:55:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-16-2020 14:55:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795516
Page 248 of 402
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-16-2020 14:55:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/15/2020Initial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795517
Page 249 of 402
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-16-2020 14:55:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11171121Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-16-2020 14:55:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1986Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-16-2020 14:56:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-16-2020 14:56:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-16-2020 14:56:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795518
Page 250 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020 12:53:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Sep-18-2020 12:53:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795519
Page 251 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-18-2020 12:54:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-18-2020 12:54:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-18-2020 12:54:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
4. Specify Status:
Date Location User Value Reason
Sep-18-2020 12:54:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795520
Page 252 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1.a
Date Location User Value Reason
Sep-18-2020 12:56:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:anxiety
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-18-2020 12:56:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 12:56:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
anxietyInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-18-2020 12:56:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-18-2020 12:56:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795521
Page 253 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Sep-18-2020 12:56:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Demerol induced an
aphylaxis
Start Date: UNK/UNK/1991
Ongoing: NO
End Date:
UNK/UNK/199
1Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-18-2020 12:56:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 12:56:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Demerol induced anaphylaxisInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-18-2020 12:56:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1991Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-18-2020 12:56:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1991Initial Entry
1.c
Date Location User Value Reason
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795522
Page 254 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Sep-18-2020 12:57:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:Allergy, Deme
rol
Start Date: UNK/UNK/19
91
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-18-2020 12:57:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 12:57:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Allergy, DemerolInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-18-2020 12:57:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1991Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-18-2020 12:57:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-18-2020 12:58:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:Radial head fracture,
Left, non-displacedInitial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795523
Page 255 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Start Date: Jul/22/2020
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-18-2020 12:58:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 12:58:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Radial head fracture, Left, non-displ
acedInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-18-2020 12:58:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/22/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-18-2020 12:58:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-18-2020 12:58:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:Pain, elbow, l
eft
Start Date: Jul/25/2020
Ongoing: YESInitial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795524
Page 256 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.e Line/MH Number:
Date Location User Value Reason
Sep-18-2020 12:58:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 12:58:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Pain, elbow, leftInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-18-2020 12:58:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/25/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-18-2020 12:58:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-18-2020 12:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:hypertension
Start Date: Jan/UNK/20
20
Ongoing: YESInitial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795525
Page 257 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.f Line/MH Number:
Date Location User Value Reason
Sep-18-2020 12:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 12:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hypertensionInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-18-2020 12:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-18-2020 12:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-18-2020 12:59:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Ter
m:C-Section
Start Date: Oct/15/2016
Ongoing: NO
End Date:
Oct/15/201
6Initial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795526
Page 258 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.g Line/MH Number:
Date Location User Value Reason
Sep-18-2020 12:59:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 12:59:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
C-SectionInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-18-2020 12:59:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2016Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-18-2020 12:59:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Oct/15/2016Initial Entry
1.h
Date Location User Value Reason
Sep-18-2020 13:00:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:8
Medical History T
erm:Hip scope, right
Start Date: Dec/UNK/2005
Ongoing: NO
End Date:
Dec/UNK/2
005Initial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795527
Page 259 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.h Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:00:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 13:00:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Hip scope, rightInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-18-2020 13:00:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/UNK/2005Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-18-2020 13:00:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/UNK/2005Initial Entry
1.i
Date Location User Value Reason
Sep-18-2020 13:04:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:9
Medical History T
erm:hip fracture, rig
ht
Start Date: Dec/UNK/2005
Ongoing: NO
End Date:
Dec/UNK/2
005Initial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795528
Page 260 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.i Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:04:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 13:04:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hip fracture, rightInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-18-2020 13:04:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/UNK/2005Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-18-2020 13:04:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/UNK/2005Initial Entry
1.j
Date Location User Value Reason
Sep-18-2020 13:04:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:10
Medical Histo
ry Term:Elbow, left, displace
d fracture
Start Date: UNK/UNK/1991
Ongoing: NO
End Date:
UNK/UNK/1991Initial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795529
Page 261 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.j Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:04:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 13:04:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Elbow, left, displaced fractureInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-18-2020 13:04:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1991Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-18-2020 13:04:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1991Initial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795530
Page 262 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1.k
Date Location User Value Reason
Sep-18-2020 13:05:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:11
Medical History
Term:elbow repair, lef
t
Start Date: UNK/UNK/199
1
Ongoing: NO
End Date:
UNK/UNK/1
991Initial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795531
Page 263 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.k Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:05:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 13:05:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
elbow repair, leftInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-18-2020 13:05:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1991Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-18-2020 13:05:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1991Initial Entry
1.l
Date Location User Value Reason
Sep-18-2020 13:06:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:12
Medical History
Term:appendicitis
Start Date: UNK/UNK/199
6Initial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795532
Page 264 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Ongoing: NO
End Date:
UNK/UNK/1
996
1.l Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:06:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 13:06:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
appendicitisInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-18-2020 13:06:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1996Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-18-2020 13:06:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1996Initial Entry
1.m
Date Location User Value Reason
Sep-18-2020 13:06:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:13
Medical History
Term:appendectomyInitial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795533
Page 265 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Start Date: UNK/UNK/199
6
Ongoing: NO
End Date:
UNK/UNK/1
996
1.m Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:06:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 13:06:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
appendectomyInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-18-2020 13:06:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1996Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-18-2020 13:06:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1996Initial Entry
1.n
Date Location User Value Reason
Sep-18-2020 13:07:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:14Initial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795534
Page 266 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Medical Histor
y Term:Tooth extraction,
wisdom
Start Date: UNK/UNK/2002
Ongoing: NO
End Date:
UNK/UNK/20
02
1.n Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:07:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 13:07:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Tooth extraction, wisdomInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-18-2020 13:07:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2002Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-18-2020 13:07:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2002Initial Entry
1.o
Date Location User Value Reason
Sep-18-2020 13:07:47
(UTC-06:00) Central TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe 15Initial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795535
Page 267 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(US & Canada) r:
Medical History
Term:Pain, tooth
Start Date: UNK/UNK/200
2
Ongoing: NO
End Date:
UNK/UNK/2
002
1.o Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:07:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 13:07:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Pain, toothInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-18-2020 13:07:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2002Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-18-2020 13:07:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2002Initial Entry
1.p
Date Location User Value Reason
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795536
Page 268 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Sep-18-2020 13:08:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 16
Medical History Te
rm:Allergy, seaso
nal
Start Date: UNK/UNK/20
01
Ongoing: YESInitial Entry
1.p Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:08:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 13:08:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Allergy, seasonalInitial Entry
1.p Start Date:
Date Location User Value Reason
Sep-18-2020 13:08:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.p Ongoing:
Date Location User Value Reason
Sep-18-2020 13:08:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Sep-18-2020 13:08:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 17
Medical History Te
rm:Myopia, bilate
ralInitial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795537
Page 269 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Start Date: UNK/UNK/19
93
Ongoing: YES
1.q Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:08:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 13:08:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Myopia, bilateralInitial Entry
1.q Start Date:
Date Location User Value Reason
Sep-18-2020 13:08:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1993Initial Entry
1.q Ongoing:
Date Location User Value Reason
Sep-18-2020 13:08:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.r
Date Location User Value Reason
Sep-18-2020 13:10:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 18
Medical History Te
rm:Sinusitis, chro
nic
Start Date: UNK/UNK/20
05
Ongoing: YESInitial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795538
Page 270 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.r Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:10:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 13:10:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sinusitis, chronicInitial Entry
1.r Start Date:
Date Location User Value Reason
Sep-18-2020 13:10:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.r Ongoing:
Date Location User Value Reason
Sep-18-2020 13:10:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.s
Date Location User Value Reason
Sep-18-2020 13:11:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:19
Medical History
Term:pneumonia
Start Date: UNK/UNK/201
8
Ongoing: NO
End Date:
UNK/UNK/2
018Initial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795539
Page 271 of 402
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171121 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.s Line/MH Number:
Date Location User Value Reason
Sep-18-2020 13:11:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 13:11:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
pneumoniaInitial Entry
1.s Start Date:
Date Location User Value Reason
Sep-18-2020 13:11:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.s Ongoing:
Date Location User Value Reason
Sep-18-2020 13:11:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.t
Date Location User Value Reason
Sep-18-2020 13:11:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:20
Medical History
Term:pneumonia
Start Date: UNK/UNK/201
6Initial Entry
090177e196d8902a\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0795540
Page 272 of 402
***Confidential***
Header Text: c4591001
Visit:
…[truncated]