Document text
Page 1 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796524
Page 2 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/25/2020
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796525
Page 3 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11171167]
2.Birth Date: /1938
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796526
Page 4 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit Not Applicable Comments
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796527
Page 5 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796528
Page 6 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796529
Page 7 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[WOUND, INSECT BITE]
Start Date: Sep/9/2020
Ongoing: NO
End Date:
Sep/16/2020
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BENIGN PROSTATE HYPERPLASIA]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CHOLECYSTECTOMY]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1999
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ROTATOR CUFF TEAR, RIGHT]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796530
Page 8 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ROTATOR CUFF REPAIR, RIGHT]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[STENT PLACEMENT, CARDIAC]
Start Date: Sep/1/2018
Ongoing: NO
End Date:
Sep/1/2018
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALCOHOL USE, SOCIAL]
Start Date: UNK/UNK/1956
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CHOLECYSTITIS]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1999
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796531
Page 9 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/2000
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERLIPIDEMIA]
Start Date: UNK/UNK/2019
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CORONARY ARTERY DISEASE]
Start Date: UNK/UNK/2010
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HERNIA, ABDOMINAL]
Start Date: UNK/UNK/2015
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CARDIAC ARTERY BLOCKAGE]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
Sep/1/2018
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796532
Page 10 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ELEVATED PROSTATE SPECIFIC ANTIGEN]
Start Date: UNK/UNK/2014
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ADENOMATOUS COLON POLYPS]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[COLON POLYP REMOVAL]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796533
Page 11 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796534
Page 12 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
2.Weight: [185.6]
3.Unit: LB
4.Height: [68.1]
5.Unit: in
6.Body Mass Index: [28.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796535
Page 13 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/25/2020
2.Randomization Number: [265785]
3.Randomization Group: [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796536
Page 14 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP58SW]
5.bSample ID [BP58SV]
5.cSample ID [BP58ST]
5.dSample ID [BPNJZY]
5.eSample ID [BPNJZX]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796537
Page 15 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP58RS]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796538
Page 16 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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/25/2020 14:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796539
Page 17 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796540
Page 18 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796541
Page 19 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Oct/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796542
Page 20 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJ8K4]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796543
Page 21 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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/14/2020 15:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796544
Page 22 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796545
Page 23 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRSRW4]
5.bSample ID [BRSRW5]
5.cSample ID [BM8YS8]
5.dSample ID [BM8YS9]
5.eSample ID [BM8YSB]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796546
Page 24 of 147
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796547
Page 25 of 147
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796548
Page 26 of 147
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796549
Page 27 of 147
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796550
Page 28 of 147
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796551
Page 29 of 147
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796552
Page 30 of 147
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796553
Page 31 of 147
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796554
Page 32 of 147
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796555
Page 33 of 147
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796556
Page 34 of 147
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
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?
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796557
Page 35 of 147
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796558
Page 36 of 147
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796559
Page 37 of 147
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796560
Page 38 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796561
Page 39 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796562
Page 40 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796563
Page 41 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796564
Page 42 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#CategoryAE Identif
ierAdverse Ev
entStart DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 VERTIGO Nov/6/2020 UNK:
UNK NO
End Date Time:
Nov/9/2020 UNK:UNK
Repeating
Pages
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796565
Page 43 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[VERTIGO]
4.Start Date Time: Nov/6/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/9/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796566
Page 44 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
[ETIOLOGY UNKNOWN]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020497416]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796567
Page 45 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796568
Page 46 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796569
Page 47 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart Da
teForm Instanc
e
1.1 VACCINATIONS NO FLU VACCIN
E Oct/30/2
020 Repeating
Pages
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796570
Page 48 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: Oct/30/2020
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796571
Page 49 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796572
Page 50 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796573
Page 51 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796574
Page 52 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796575
Page 53 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796576
Page 54 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796577
Page 55 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/11/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796578
Page 56 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796579
Page 57 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796580
Page 58 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796581
Page 59 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796582
Page 60 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796583
Page 61 of 147
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796584
Page 62 of 147
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796585
Page 63 of 147
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796586
Page 64 of 147
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796587
Page 65 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796588
Page 66 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796589
Page 67 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796590
Page 68 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/11/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796591
Page 69 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796592
Page 70 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796593
Page 71 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/11/2020
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796594
Page 72 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796595
Page 73 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 11:00:25 (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.
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796596
Page 74 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Sep-28-2020 14:55:58 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0796597
Page 75 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-28-2020 14:56:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0796598
Page 76 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Sep-28-2020 14:56:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0796599
Page 77 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Oct-06-2020 16:36:10 (UTC-06:00) Central
Time (US & Canada)
4Sep-29-2020 17:52:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0796600
Page 78 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Oct-06-2020 16:36:23 (UTC-06:00) Central
Time (US & Canada)
4Sep-29-2020 17:36:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0796601
Page 79 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 11:00:25 (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-14-2020 19:09:23 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-17-2020 18:09:46 (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-17-2020 14:31:31 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0796602
Page 80 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Approved Nov-16-2020 16:30:37 (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-12-2020 18:04:16 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Larkin
Wadsworth Approved Nov-12-2020 10:19:09 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LarkinWadsworth, 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.
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796603
Page 81 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-28-2020 14:54:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-28-2020 14:54:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796604
Page 82 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-28-2020 14:55:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/25/2020Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796605
Page 83 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-28-2020 14:54:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11171167Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-28-2020 14:54:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1938Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-28-2020 14:55:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-28-2020 14:55:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-28-2020 14:55:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796606
Page 84 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-28-2020 14:55:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Sep-28-2020 14:55:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796607
Page 85 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-28-2020 14:56:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-28-2020 14:56:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-28-2020 14:56:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
4. Specify Status:
Date Location User Value Reason
Sep-28-2020 14:56:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796608
Page 86 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Sep-28-2020 14:57:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:WOUND, INSE
CT BITE
Start Date: Sep/9/2020
Ongoing: NO
End Date:
Sep/16/2020Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:57:36
(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-28-2020 14:57:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WOUND, INSECT BITEInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-28-2020 14:57:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-28-2020 14:57:36 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0796609
Page 87 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US & Canada)NO
End Date:
Sep/16/2020
1.b
Date Location User Value Reason
Sep-30-2020 17:12:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:2
Medical Hi
story Term
:BENIGN PROSTA
TE HYPERPLASI
A
Start Date: UNK/UNK/2015
Ongoing: YESTranscription Error
Sep-28-2020 14:58:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical Hi
story Term
:BENIGN PROSTR
ATE HYPERPLAS
IA
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0796610
Page 88 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.b Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:58:09
(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 ValueReason
Oct-02-2020
07:03:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse
satisfies query
Sep-30-2020
17:12:10
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query
1: An
swere
dTranscription
Error
Sep-30-2020
17:12:10
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
BENI
GN P
ROST
ATE
HYP
ERPL
ASIATranscription
Error
Sep-28-2020
17:58:09
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
1: Op
enedClarify BENIGN
PROSTRATE
HYPERPLASIA
as
follows...Should
the spelling be
BENIGN
PROSTATE
HYPERPLASIA?
If so, edit.
Otherwise clarify.
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0796611
Page 89 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Thank you.
Sep-28-2020
14:58:09
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
BENI
GN P
ROST
RATE
HYP
ERPL
ASIAInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-28-2020 14:58:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-28-2020 14:58:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-28-2020 15:00:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:CHOLECYSTE
CTOMY
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1
999Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796612
Page 90 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.c Line/MH Number:
Date Location User Value Reason
Sep-28-2020 15:00:48
(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-28-2020 15:00:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHOLECYSTECTOMYInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-28-2020 15:00:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1999Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-28-2020 15:00:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1999Initial Entry
1.d
Date Location User Value Reason
Sep-28-2020 15:01:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:ROTATOR CUFF
TEAR, RIGHT
Start Date: UNK/UNK/2001Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796613
Page 91 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Ongoing: NO
End Date:
UNK/UNK/200
1
1.d Line/MH Number:
Date Location User Value Reason
Sep-28-2020 15:01:30
(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-28-2020 15:01:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ROTATOR CUFF TEAR, RIGH
TInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-28-2020 15:01:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-28-2020 15:01:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2001Initial Entry
1.e
Date Location User Value Reason
Sep-28-2020 15:01:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:5Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796614
Page 92 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Medical His
tory Term:ROTATOR CUFF R
EPAIR, RIGHT
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
1.e Line/MH Number:
Date Location User Value Reason
Sep-28-2020 15:01:57
(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-28-2020 15:01:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ROTATOR CUFF REPAIR, RIG
HTInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-28-2020 15:01:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-28-2020 15:01:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2001Initial Entry
1.f
Date Location User Value Reason
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796615
Page 93 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-28-2020 15:07:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:6
Medical His
tory Term:STENT PLACEM
ENT, CARDIAC
Start Date: Sep/1/2018
Ongoing: NO
End Date:
Sep/1/2018New Information
Sep-28-2020 15:03:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histo
ry Term:STENT PLAC
EMENT
Start Date: Sep/1/2018
Ongoing: NO
End Date:
Sep/1/2018Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796616
Page 94 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.f Line/MH Number:
Date Location User Value Reason
Sep-28-2020 15:03:31
(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-28-2020 15:07:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STENT PLACEMENT, CARDI
ACNew Information
Sep-28-2020 15:03:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STENT PLACEMENTInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-28-2020 15:03:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-28-2020 15:03:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Sep/1/2018Initial Entry
1.g
Date Location User Value Reason
Sep-28-2020 15:04:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histo
ry Term:ALCOHOL USE
, SOCIALInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796617
Page 95 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Start Date: UNK/UNK/1956
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Sep-28-2020 15:04:00
(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-28-2020 15:04:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ALCOHOL USE, SOCIALInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-28-2020 15:04:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1956Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-28-2020 15:04:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-28-2020 15:04:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8
Medical History
Term:CHOLECYSTI
TIS
Start Date: UNK/UNK/19
99Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796618
Page 96 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Ongoing: NO
End Date:
UNK/UNK/
1999
1.h Line/MH Number:
Date Location User Value Reason
Sep-28-2020 15:04:38
(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-28-2020 15:04:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHOLECYSTITISInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-28-2020 15:04:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1999Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-28-2020 15:04:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1999Initial Entry
1.i
Date Location User Value Reason
Sep-28-2020 15:04:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796619
Page 97 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Medical History
Term:HYPERTENS
ION
Start Date: UNK/UNK/2
000
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Sep-28-2020 15:04:58
(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-28-2020 15:04:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HYPERTENSIONInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796620
Page 98 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.i Start Date:
Date Location User Value Reason
Sep-28-2020 15:04:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-28-2020 15:04:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Sep-28-2020 15:05:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:10
Medical History
Term:HYPERLIPID
EMIA
Start Date: UNK/UNK/20
19
Ongoing: YESInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796621
Page 99 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.j Line/MH Number:
Date Location User Value Reason
Sep-28-2020 15:05:20
(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-28-2020 15:05:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HYPERLIPIDEMIAInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-28-2020 15:05:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-28-2020 15:05:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Sep-28-2020 15:05:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:11
Medical Hist
ory Term:CORONARY ART
ERY DISEASE
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796622
Page 100 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.k Line/MH Number:
Date Location User Value Reason
Sep-28-2020 15:05:46
(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-28-2020 15:05:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CORONARY ARTERY DISEAS
EInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-28-2020 15:05:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-28-2020 15:05:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Sep-28-2020 15:06:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:12
Medical Histor
y Term:HERNIA, ABD
OMINAL
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796623
Page 101 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.l Line/MH Number:
Date Location User Value Reason
Sep-28-2020 15:06:02
(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-28-2020 15:06:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HERNIA, ABDOMINALInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-28-2020 15:06:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.l Ongoing:
Date Location User Value Reason
Oct-01-2020 09:24:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-30-2020 17:13:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered PER
INVESTIGATOR
PHYSICAL EXAM,
HERNIA IS
PRESENT
Sep-29-2020 15:26:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY-
HERNIA,
ABDOMINAL is
reported as ongoing.
Please confirm if a
procedure/surgery
was performed and if
so please add to
MedHx as a separate
entry.
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796624
Page 102 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-28-2020 15:06:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Sep-28-2020 15:06:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:13
Medical His
tory Term:CARDIAC ARTER
Y BLOCKAGE
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
Sep/1/2018Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0796625
Page 103 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.m Line/MH Number:
Date Location User Value Reason
Sep-28-2020 15:06:51
(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-28-2020 15:06:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CARDIAC ARTERY BLOCKA
GEInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-28-2020 15:06:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-28-2020 15:06:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Sep/1/2018Initial Entry
1.n
Date Location User Value Reason
Nov-17-2020 14:31:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:14
Medical H
istory Ter
m:ELEVATED PROST
ATE SPECIFIC ANT
IGEN
Start Date
:UNK/UNK/2014
Ongoing: YESInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796626
Page 104 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.n Line/MH Number:
Date Location User Value Reason
Nov-17-2020 14:31:31
(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
Nov-17-2020 14:31:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ELEVATED PROSTATE SPECI
FIC ANTIGENInitial Entry
1.n Start Date:
Date Location User Value Reason
Nov-17-2020 14:31:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.n Ongoing:
Date Location User Value Reason
Nov-17-2020 14:31:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Nov-17-2020 14:32:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:15
Medical His
tory Term:ADENOMATOUS
COLON POLYPS
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796627
Page 105 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.o Line/MH Number:
Date Location User Value Reason
Nov-17-2020 14:32:02
(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
Nov-17-2020 14:32:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADENOMATOUS COLON POL
YPSInitial Entry
1.o Start Date:
Date Location User Value Reason
Nov-17-2020 14:32:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.o Ongoing:
Date Location User Value Reason
Nov-17-2020 14:32:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.p
Date Location User Value Reason
Nov-17-2020 14:32:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:16
Medical Hist
ory Term:COLON POLYP
REMOVAL
Start Date: UNK/UNK/2015Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796628
Page 106 of 147
***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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Ongoing: NO
End Date:
UNK/UNK/20
15
1.p Line/MH Number:
Date Location User Value Reason
Nov-17-2020 14:32:37
(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
Nov-17-2020 14:32:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COLON POLYP REMOVALInitial Entry
1.p Start Date:
Date Location User Value Reason
Nov-17-2020 14:32:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.p Ongoing:
Date Location User Value Reason
Nov-17-2020 14:32:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796629
Page 107 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-28-2020 15:07:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796630
Page 108 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-28-2020 15:08:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-28-2020 15:08:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
185.6Initial Entry
3. Unit:
Date Location User Value Reason
Sep-28-2020 15:08:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-28-2020 15:08:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
68.1Initial Entry
5. Unit:
Date Location User Value Reason
Sep-28-2020 15:08:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-28-2020 15:08:10 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796631
Page 109 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US & Canada)(autocalc) 28.1
7.a
Date Location User Value Reason
Sep-28-2020 15:08:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 97.9
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-28-2020 15:08:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-28-2020 15:08:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.9Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-28-2020 15:08:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-28-2020 15:08:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796632
Page 110 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - 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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-28-2020 15:08:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-28-2020 15:08:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
265785Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796633
Page 111 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 17:51:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 17:51:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 17:52:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-29-2020 17:51:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-29-2020 17:51:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-06-2020 16:36:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0796634
Page 112 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-06-2020 01:08:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Not required now
Oct-05-2020 09:04:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: If sample was
collected according
to protocol, please
do not record any
response in this
specified field,
Thank you.
Sep-29-2020 17:52:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Sep-29-2020 17:52:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP58SWInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020 17:52:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP58SWInitial Entry
5.b
Date Location User Value Reason
Sep-29-2020 17:52:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP58SVInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-29-2020 17:52:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP58SVInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796635
Page 113 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.c
Date Location User Value Reason
Sep-29-2020 17:52:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP58STInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-29-2020 17:52:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP58STInitial Entry
5.d
Date Location User Value Reason
Sep-29-2020 17:53:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPNJZYInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-29-2020 17:53:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPNJZYInitial Entry
5.e
Date Location User Value Reason
Sep-29-2020 17:53:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPNJZXInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-29-2020 17:53:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPNJZXInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796636
Page 114 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 17:35:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 17:35:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 17:36:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-29-2020 17:35:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-29-2020 17:35:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-06-2020 16:36:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0796637
Page 115 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-06-2020 01:08:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Not required now
Oct-05-2020 09:04:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: If sample was
collected according
to protocol, please
do not record any
response in this
specified field,
Thank you.
Sep-29-2020 17:36:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Sep-29-2020 17:36:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP58RSInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020 17:36:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP58RSInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796638
Page 116 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-28-2020 15:08:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020 15:08:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020 15:08:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-28-2020 15:08:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020 14:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-28-2020 15:08:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-28-2020 15:08:50 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0796639
Page 117 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US & Canada)LEFT
7. Route:
Date Location User Value Reason
Sep-28-2020 15:08:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-28-2020 15:08:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-28-2020 15:08:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0796640
Page 118 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-28-2020 15:08:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796641
Page 119 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-17-2020 17:08:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796642
Page 120 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Oct-17-2020 17:09:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
2.a
Date Location User Value Reason
Oct-17-2020 17:09:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 97.8
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-17-2020 17:09:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-17-2020 17:09:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.8Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-17-2020 17:09:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796643
Page 121 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.a Temperature Location:
Date Location User Value Reason
Oct-17-2020 17:09:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796644
Page 122 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 10:57:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 10:57:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 10:58:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 10:57:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 10:57:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020 10:58:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRJ8K4Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796645
Page 123 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 10:58:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRJ8K4Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796646
Page 124 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-17-2020 17:09:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-17-2020 17:09:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-17-2020 17:09:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-17-2020 17:09:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020 15:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-17-2020 17:09:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-17-2020 17:09:40 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0796647
Page 125 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US & Canada)LEFT
7. Route:
Date Location User Value Reason
Oct-17-2020 17:09:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-17-2020 17:09:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-17-2020 17:09:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0796648
Page 126 of 147
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-12-2020 20:17:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796649
Page 127 of 147
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-12-2020 18:04:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020 18:04:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-12-2020 18:04:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-12-2020 18:04:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-12-2020 18:04:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/11/2020Initial Entry
5.a
Date Location User Value Reason
Nov-12-2020 18:04:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRSRW4Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796650
Page 128 of 147
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Nov-12-2020 18:04:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRSRW4Initial Entry
5.b
Date Location User Value Reason
Nov-12-2020 18:04:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRSRW5Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-12-2020 18:04:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRSRW5Initial Entry
5.c
Date Location User Value Reason
Nov-12-2020 18:54:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM8YS8Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-12-2020 18:54:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM8YS8Initial Entry
5.d
Date Location User Value Reason
Nov-12-2020 18:54:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM8YS9Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796651
Page 129 of 147
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Nov-12-2020 18:54:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM8YS9Initial Entry
5.e
Date Location User Value Reason
Nov-12-2020 18:55:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM8YSBInitial Entry
5.e Sample ID
Date Location User Value Reason
Nov-12-2020 18:55:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM8YSBInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796652
Page 130 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796653
Page 131 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-25-2021 17:10:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 3: Closed Ok. Pls provide in a
FU letter: 1. Covid
test results, 2.
Duration of
symptoms as
described in your
answer. The subject
had low grade fever
in association with
other symptoms and
other Med conditions
should have been
rolled out. Thanks
Feb-19-2021 14:35:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered ALL THE
INFORMATION IS
IN THE SAE
DOCUMENT
NARRATIVE,
WHAT ARE YOU
WANTING DONE
HERE?
Feb-19-2021 13:19:27
(UTC-06:00) CentralACV0PFEINFP6000 Giselle
CastilloQuery 3: Reissued:Opened Thanks for your
response. Pls provide
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0796654
Page 132 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada) these information
("covid testing,
duration of
symptoms UNK and
dizziness,
generalized
weakness, nausea
and a LOW GRADE
FEVER associated to
episodes of vertigo")
in a FU form so it is
included in the safety
report.
Feb-19-2021 12:52:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered PER INTERVIEW
WITH SUBJECT, A
COUPLE OF
EPISODES OF
VERTIGO
HAPPENED OVER
THE COUPLE OF
DAYS. DOES NOT
RECALL TIME
DURATION OF
EPISODES.
Feb-17-2021 02:11:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 3: Reissued:Opened Thanks for
confirming. Would
you please clarify for
how long was the
duration of the
symptoms?
Feb-11-2021 17:38:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered PER SAE
DOCUMENT,
COVID
SCREENING WAS
RESULTED AS
NOT-DETECTED
Feb-03-2021 08:28:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 3: Opened CLINICAL_ Per
report, the subject
presented dizziness,
generalized
weakness, nausea
and a LOW GRADE
FEVER. Kindly
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0796655
Page 133 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
clarify if those
symptoms were
assessed for infection
during admission.
Thanks
Jan-25-2021 16:44:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Closed Response satisfies
query
Jan-21-2021 12:21:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered PER PARTICIPANT,
THESE
SYMPTOMS WERE
ONLY PRESENT
DURING THE
EPISODE(S) OF
VERTIGO.
Jan-10-2021 12:37:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Opened Per report, the
subject presented
with
nausea/dizziness.
Kindly specify for
how long the
participant had these
symptoms? Thank
you.
Jan-06-2021 13:37:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Appreciate the FU.
Per report, "he
received an EKG that
showed
bradycardia", was
this event considered
the final diagnosis on
discharge? Thanks
Jan-04-2021 09:47:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Medical records
received and
reviewed, update
summary being
submitted on
05Dec2020
Dec-22-2020 13:15:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Per SAE report, the
subject had an MRI
during hospital stay.
However, results
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0796656
Page 134 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
have not been
provided. Kindly
submit a FU form
with this information
and further relevant
labs tests performed.
Thank you.
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VERTIGOInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-08-2021 14:26:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-08-2021 09:04:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New Information
Mar-08-2021 09:04:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/6/2020 UNK:UNKNew Information
Mar-08-2021 03:35:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON:
AER#2020497416
,onset date was
updated to
06Nov2020 Safety
database however,
recorded as
07Nov2020 on AE
CRF. Please confirm
correct Onset Date. If
safety update is
required, please
submit a follow-up
SAE form.
Jan-29-2021 11:50:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed SDB updated
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796657
Page 135 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Jan-24-2021 21:28:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate Pending SDB update
Jan-21-2021 12:23:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered FAXED FINAL
SUMMARY
W/REVISIONS
21JAN2021
Jan-08-2021 06:03:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON 1:
Please confirm if the
follow up AEM form
was submitted to
indicate the correct
onset date as
07NOV2020. Per
latest SAE listing
onset date is still
07DEC2020
Jan-06-2021 05:22:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate Pending SDB
updated
Jan-05-2021 11:21:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered FAXED FINAL
SUMMARY
W/REVISIONS
05JAN2020
Jan-05-2021 06:51:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020497416
,onset date was
recorded as
07Dec2020 in Safety
database however,
recorded as
07Nov2020 on AE
CRF. Please confirm
correct Onset Date. If
safety update is
required, please
submit a follow-up
SAE form.
Jan-04-2021 09:46:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/7/2020 UNK:UNKChanged Information
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796658
Page 136 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-04-2021 09:47:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/9/2020 UNK:UNKNew Information
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/9/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
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).
Date Location User Value Reason
Dec-17-2020 05:53:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE VERTIGO:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796659
Page 137 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Adverse Event
Number" is blank.
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
NOInitial Entry
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.
Date Location User Value Reason
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796660
Page 138 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
ETIOLOGY UNKNOWNInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796661
Page 139 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Dec-14-2020 19:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-17-2020 05:53:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020497416Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796662
Page 140 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Nov-12-2020 20:18:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796663
Page 141 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - 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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-12-2020 20:18:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-12-2020 20:18:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-12-2020 20:18:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Nov-12-2020 20:18:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FLU VACCINEInitial Entry
5. Date:
Date Location User Value Reason
Nov-12-2020 20:18:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/30/2020Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796664
Page 142 of 147
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - 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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-12-2020 20:18:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-12-2020 20:18:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-12-2020 20:18:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796665
Page 143 of 147
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-12-2021 19:23:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/11/2021Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796666
Page 144 of 147
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-12-2021 19:23:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-12-2021 19:23:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-12-2021 19:23:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796667
Page 145 of 147
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-12-2021 19:23:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/11/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-12-2021 19:23:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796668
Page 146 of 147
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-12-2020 20:18:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-28-2020 15:08:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-28-2020 14:56:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-12-2020 20:18:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/11/2020Initial Entry
Sep-28-2020 15:08:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
Sep-28-2020 14:56:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
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Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail 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: 11171167 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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1. Casebook Signature
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Nov-10-2020 17:07:54
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090177e196ae3dc9\Final\Final On: 01-Apr-2021 04:41 (GMT)
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FDA-CBER-2021-5683-0796670