Document text
Page 1 of 172
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 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
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795098
Page 2 of 172
***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: 11171088 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/3/2020
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795099
Page 3 of 172
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11171088]
2.Birth Date: /1940
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:
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795100
Page 4 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/3/2020
2.Erroneous Visit
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795101
Page 5 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 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
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795102
Page 6 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795103
Page 7 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 11171088 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:[CHOLECYSTECTOMY]
Start Date: Aug/UNK/2018
Ongoing: NO
End Date:
Aug/UNK/2018
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GALLBLADDER OBSTRUCTION]
Start Date: Aug/UNK/2018
Ongoing: NO
End Date:
Aug/UNK/2018
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LEFT KNEE SURGERY]
Start Date: UNK/UNK/1962
Ongoing: NO
End Date:
UNK/UNK/1962
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LEFT KNEE BREAK]
Start Date: UNK/UNK/1962
Ongoing: NO
End Date:
UNK/UNK/1962
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795104
Page 8 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 11171088 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:[CARDIAC PACEMAKER PLACEMENT]
Start Date: Aug/UNK/2018
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CARDIAC BYPASS]
Start Date: Jul/UNK/2001
Ongoing: NO
End Date:
Jul/UNK/2001
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RIGHT HIP REPLACEMENT]
Start Date: Apr/UNK/2016
Ongoing: NO
End Date:
Apr/UNK/2016
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RIGHT HIP DEGENERATION]
Start Date: Apr/UNK/2016
Ongoing: NO
End Date:
Apr/UNK/2016
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795105
Page 9 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 11171088 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:[LEFT KNEE REPLACEMENT]
Start Date: Apr/UNK/2015
Ongoing: NO
End Date:
Apr/UNK/2015
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LEFT KNEE DEGENERATION]
Start Date: Apr/UNK/2015
Ongoing: NO
End Date:
Apr/UNK/2015
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RIGHT KNEE REPLACEMENT]
Start Date: Apr/UNK/2014
Ongoing: NO
End Date:
Apr/UNK/2014
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RIGHT KNEE DEGENERATION]
Start Date: Apr/UNK/2014
Ongoing: NO
End Date:
Apr/UNK/2014
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795106
Page 10 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RIGHT EYE CLOUDING MEMBRANE]
Start Date: Aug/31/2020
Ongoing: NO
End Date:
Aug/31/2020
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RIGHT EYE CAPSULOTOMY LASER PROCEDURE]
Start Date: Aug/31/2020
Ongoing: NO
End Date:
Aug/31/2020
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LEFT EYE CLOUDING MEMBRANE]
Start Date: Aug/17/2020
Ongoing: NO
End Date:
Aug/17/2020
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LEFT EYE CAPSULOTOMY PROCEDURE]
Start Date: Aug/17/2020
Ongoing: NO
End Date:
Aug/17/2020
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795107
Page 11 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SULFA ALLERGY]
Start Date: UNK/UNK/2005
Ongoing: YES
1.rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BENIGN TUMOR LOWER BACK ]
Start Date: Jun/UNK/2020
Ongoing: NO
End Date:
Jun/UNK/2020
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ACID REFLUX]
Start Date: UNK/UNK/1990
Ongoing: YES
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BENIGN PROSTATIC HYPERPLASIA]
Start Date: UNK/UNK/2017
Ongoing: YES
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BILATERAL VISUAL IMPAIRMENT]
Start Date: UNK/UNK/1948
Ongoing: YES
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795108
Page 12 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SEASONAL ALLERGIES]
Start Date: UNK/UNK/1948
Ongoing: YES
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BILATERAL EYE CATARACTS]
Start Date: Jan/UNK/2019
Ongoing: NO
End Date:
Jan/UNK/2019
1 xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BILATERAL EYE CATARACT SURGERY]
Start Date: Jan/UNK/2019
Ongoing: NO
End Date:
Jan/UNK/2019
1.yLine/MH Number: [25]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GLAUCOMA]
Start Date: UNK/UNK/2019
Ongoing: YES
1.zLine/MH Number: [26]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CORONARY ARTERY DISEASE]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795109
Page 13 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.aaLine/MH Number: [27]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERLIPIDEMIA]
Start Date: UNK/UNK/2005
Ongoing: YES
1.abLine/MH Number: [28]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/2005
Ongoing: YES
1.acLine/MH Number: [29]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ANEMIA]
Start Date: UNK/UNK/2018
Ongoing: YES
1.adLine/MH Number: [30]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ACUTE COLITIS]
Start Date: UNK/UNK/2018
Ongoing: YES
1.aeLine/MH Number: [31]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ELEVATED PROSTATE SPECIFIC ANTIGEN]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795110
Page 14 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.afLine/MH Number: [32]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ATRIAL FIBRILLATION]
Start Date: UNK/UNK/2018
Ongoing: YES
1.agLine/MH Number: [33]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SICK SINUS SYNDROME]
Start Date: UNK/UNK/2018
Ongoing: YES
1.ahLine/MH Number: [34]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CHRONIC THROMBOCYTOPENIA]
Start Date: Jul/UNK/2001
Ongoing: YES
1.aiLine/MH Number: [35]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MYCARDIAL INFARCT]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795111
Page 15 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
2.Weight: [186.0]
3.Unit: LB
4.Height: [67.3]
5.Unit: in
6.Body Mass Index: [28.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [96.3] Comments
Unit: F Comments
Temperature Location: ORAL CAVITY Comments
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795112
Page 16 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/3/2020
2.Randomization Number: [244992]
3.Randomization Group: [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795113
Page 17 of 172
***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: 11171088 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/3/2020
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 [BM8YCZ]
5.bSample ID [BM8YD0]
5.cSample ID [BM8YD1]
5.dSample ID [BPRV19]
5.eSample ID [BPRV1B]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795114
Page 18 of 172
***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: 11171088 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/3/2020
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 [BP58P2]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795115
Page 19 of 172
***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: 11171088 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/3/2020 16:07
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
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795116
Page 20 of 172
***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: 11171088 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
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795117
Page 21 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit Comments
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795118
Page 22 of 172
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795119
Page 23 of 172
***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: 11171088 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/23/2020
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 [BM8YN1]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795120
Page 24 of 172
***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: 11171088 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/23/2020 14:05
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
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795121
Page 25 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795122
Page 26 of 172
***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: 11171088 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:
Oct/21/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRSRPL]
5.bSample ID [BRSRPM]
5.cSample ID [BP58WP]
5.dSample ID [BP58WR]
5.eSample ID [BP58WS]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795123
Page 27 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795124
Page 28 of 172
***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: 11171088 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 [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795125
Page 29 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795126
Page 30 of 172
***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: 11171088 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 [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795127
Page 31 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795128
Page 32 of 172
***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: 11171088 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 [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795129
Page 33 of 172
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11171088 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:
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795130
Page 34 of 172
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11171088 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: [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795131
Page 35 of 172
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11171088 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 [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795132
Page 36 of 172
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11171088 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 [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795133
Page 37 of 172
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11171088 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?
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795134
Page 38 of 172
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 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:
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795135
Page 39 of 172
***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: 11171088 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:
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795136
Page 40 of 172
***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: 11171088 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 [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795137
Page 41 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795138
Page 42 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795139
Page 43 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795140
Page 44 of 172
***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: 11171088 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: [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795141
Page 45 of 172
***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: 11171088 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:
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795142
Page 46 of 172
***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: 11171088 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 [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795143
Page 47 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EV
ENT 1 NON CARDIAC CHEST
PAIN Nov/14/2020 UNK:
UNK NO
End Date Time:
Nov/16/2020 UNK:UNK
Repeating
Pages
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795144
Page 48 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 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)[NON CARDIAC CHEST PAIN]
4.Start Date Time: Nov/14/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/16/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[PRIOR CARDIAC MEDICAL HISTORY]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795145
Page 49 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
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[2020465905]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795146
Page 50 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795147
Page 51 of 172
***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: 11171088 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[ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795148
Page 52 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre-
specifiedName of Medic
ationStart Dat
eForm Instanc
e
1.1 VACCINATIONS NO FLU VACCINE Oct/21/20
20 Repeating
Pages
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795149
Page 53 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 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/21/2020
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795150
Page 54 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795151
Page 55 of 172
***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: 11171088 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?
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795152
Page 56 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795153
Page 57 of 172
***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: 11171088 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?
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795154
Page 58 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795155
Page 59 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795156
Page 60 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795157
Page 61 of 172
***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: 11171088 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:
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795158
Page 62 of 172
***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: 11171088 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?
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795159
Page 63 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795160
Page 64 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795161
Page 65 of 172
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795162
Page 66 of 172
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795163
Page 67 of 172
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 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 [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795164
Page 68 of 172
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 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 [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795165
Page 69 of 172
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795166
Page 70 of 172
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 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
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795167
Page 71 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/17/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795168
Page 72 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795169
Page 73 of 172
***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: 11171088 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: [ ]
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795170
Page 74 of 172
***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: 11171088 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 Oct/21/2020
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795171
Page 75 of 172
***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: 11171088 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
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795172
Page 76 of 172
***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: 11171088 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 12:12:05 (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.
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795173
Page 77 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-05-2020 16:31:55 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795174
Page 78 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
7.aSep-05-2020 17:55:22 (UTC-06:00) Central Time
(US & Canada)NOT CLINICALLY SIGNIFICANT
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795175
Page 79 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
7.aSep-05-2020 17:55:22 (UTC-06:00) Central Time
(US & Canada)NOT CLINICALLY SIGNIFICANT
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795176
Page 80 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
7.aSep-05-2020 17:55:22 (UTC-06:00) Central Time
(US & Canada)NOT CLINICALLY SIGNIFICANT
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795177
Page 81 of 172
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Oct-06-2020 16:14:32 (UTC-06:00) Central Time
(US & Canada)
2Sep-25-2020 14:11:54 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Sep-18-2020 10:22:31 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795178
Page 82 of 172
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Oct-06-2020 16:14:14 (UTC-06:00) Central Time
(US & Canada)
4Sep-23-2020 15:46:55 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795179
Page 83 of 172
***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: 11171088 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 12:12:05 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-25-2020 20:45:04 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Larkin
Wadsworth Approved Nov-03-2020 14:12:16 (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.
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795180
Page 84 of 172
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 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-05-2020 16:31:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-05-2020 16:31:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795181
Page 85 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-05-2020 16:31:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/3/2020Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795182
Page 86 of 172
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-05-2020 16:31:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11171088Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-05-2020 16:31:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1940Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-05-2020 16:31:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-05-2020 16:31:39
(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-05-2020 16:31:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795183
Page 87 of 172
***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: 11171088 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-05-2020 16:31:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795184
Page 88 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 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-05-2020 16:32:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-05-2020 16:32:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-05-2020 16:32:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795185
Page 89 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Sep-05-2020 16:33:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:CHOLECYSTECT
OMY
Start Date: Aug/UNK/2018
Ongoing: NO
End Date:
Aug/UNK/2018Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-05-2020 16:33:24
(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
Dec-07-2020 15:13:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Closed Response satisfies
query
Dec-07-2020 13:47:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Dec-03-2020 10:39:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Opened Per report, the subject
has a MedHx of
coronary artery disease
(CAD)
hyperlipidemia,
hypertension, atrial
fibrillation, sick sinus
syndrome, chronic
thrombocytopenia, and
myocardial infarct not
recorded on CRF.
Kindly revise and
update page. Thanks
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0795186
Page 90 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-05-2020 16:33:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHOLECYSTECTOMYInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-05-2020 16:33:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-05-2020 16:33:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/UNK/2018Initial Entry
1.b
Date Location User Value Reason
Sep-05-2020 16:34:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:GALLBLADDER OB
STRUCTION
Start Date: Aug/UNK/2018
Ongoing: NO
End Date:
Aug/UNK/2018Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795187
Page 91 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.b Line/MH Number:
Date Location User Value Reason
Sep-05-2020 16:34:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-05-2020 16:34:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
GALLBLADDER OBSTRUCTIO
NInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-05-2020 16:34:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-05-2020 16:34:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/UNK/2018Initial Entry
1.c
Date Location User Value Reason
Sep-05-2020 16:35:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:LEFT KNEE SUR
GERY
Start Date: UNK/UNK/1962
Ongoing: NO
End Date:
UNK/UNK/196
2Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795188
Page 92 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.c Line/MH Number:
Date Location User Value Reason
Sep-05-2020 16:35:13
(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-05-2020 16:35:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFT KNEE SURGERYInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-05-2020 16:35:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1962Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-05-2020 16:35:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1962Initial Entry
1.d
Date Location User Value Reason
Sep-05-2020 16:35:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:LEFT KNEE BR
EAK
Start Date: UNK/UNK/1962
Ongoing: NO
End Date:
UNK/UNK/19
62Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795189
Page 93 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.d Line/MH Number:
Date Location User Value Reason
Sep-05-2020 16:35:37
(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-05-2020 16:35:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFT KNEE BREAKInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-05-2020 16:35:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1962Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-05-2020 16:35:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1962Initial Entry
1.e
Date Location User Value Reason
Sep-05-2020 16:36:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Hist
ory Term:CARDIAC PACEMAK
ER PLACEMENT
Start Date: Aug/UNK/2018
Ongoing: YESInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795190
Page 94 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.e Line/MH Number:
Date Location User Value Reason
Sep-05-2020 16:36:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-05-2020 16:36:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CARDIAC PACEMAKER PLACE
MENTInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-05-2020 16:36:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-05-2020 16:36:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-05-2020 16:37:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History T
erm:CARDIAC BYP
ASS
Start Date: Jul/UNK/2001
Ongoing: NO
End Date:
Jul/UNK/2001Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795191
Page 95 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.f Line/MH Number:
Date Location User Value Reason
Sep-05-2020 16:37:30
(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-05-2020 16:37:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CARDIAC BYPASSInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-05-2020 16:37:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/UNK/2001Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-05-2020 16:37:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jul/UNK/2001Initial Entry
1.g
Date Location User Value Reason
Sep-05-2020 16:38:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:RIGHT HIP REPLA
CEMENT
Start Date: Apr/UNK/2016
Ongoing: NO
End Date:
Apr/UNK/2016Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795192
Page 96 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.g Line/MH Number:
Date Location User Value Reason
Sep-05-2020 16:38:03
(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-05-2020 16:38:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHT HIP REPLACEMENTInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-05-2020 16:38:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/UNK/2016Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-05-2020 16:38:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Apr/UNK/2016Initial Entry
1.h
Date Location User Value Reason
Sep-05-2020 16:38:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:RIGHT HIP DEGEN
ERATION
Start Date: Apr/UNK/2016
Ongoing: NO
End Date:
Apr/UNK/2016Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795193
Page 97 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.h Line/MH Number:
Date Location User Value Reason
Sep-05-2020 16:38:35
(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-05-2020 16:38:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHT HIP DEGENERATIONInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-05-2020 16:38:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/UNK/2016Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-05-2020 16:38:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Apr/UNK/2016Initial Entry
1.i
Date Location User Value Reason
Sep-05-2020 16:39:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9
Medical Histor
y Term:LEFT KNEE REPLA
CEMENT
Start Date: Apr/UNK/2015
Ongoing: NO
End Date:
Apr/UNK/2015Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795194
Page 98 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.i Line/MH Number:
Date Location User Value Reason
Sep-05-2020 16:39:05
(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-05-2020 16:39:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFT KNEE REPLACEMENTInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-05-2020 16:39:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/UNK/2015Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-05-2020 16:39:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Apr/UNK/2015Initial Entry
1.j
Date Location User Value Reason
Sep-16-2020 15:38:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:10
Medical Histo
ry Term:LEFT KNEE DEGE
NERATION
Start Date: Apr/UNK/2015
Ongoing: NO
End Date:
Apr/UNK/2015Changed Information
Sep-05-2020 16:39:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795195
Page 99 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Medical Histo
ry Term:LEFT KNEE DEGE
NERATION
Start Date: Apr/UNK/2016
Ongoing: NO
End Date:
Apr/UNK/2016
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795196
Page 100 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.j Line/MH Number:
Date Location User Value Reason
Sep-05-2020 16:39:45
(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-17-2020 06:59:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-16-2020 15:38:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Sep-08-2020 11:33:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY - Please
confirm LEFT KNEE
DEGENERATION
occurred after LEFT
KNEE
REPLACEMENT as
currently reported.
Update if applicable.
Sep-05-2020 16:39:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFT KNEE DEGENERATIONInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-16-2020 15:38:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/UNK/2015Changed Information
Sep-05-2020 16:39:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/UNK/2016Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-16-2020 15:38:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:Changed Information
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0795197
Page 101 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Apr/UNK/2015
Sep-05-2020 16:39:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Apr/UNK/2016Initial Entry
1.k
Date Location User Value Reason
Sep-05-2020 16:40:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:11
Medical Histo
ry Term:RIGHT KNEE REPL
ACEMENT
Start Date: Apr/UNK/2014
Ongoing: NO
End Date:
Apr/UNK/2014Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795198
Page 102 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.k Line/MH Number:
Date Location User Value Reason
Sep-05-2020 16:40:17
(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-05-2020 16:40:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHT KNEE REPLACEMENTInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-05-2020 16:40:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/UNK/2014Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-05-2020 16:40:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Apr/UNK/2014Initial Entry
1.l
Date Location User Value Reason
Sep-05-2020 16:40:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:12
Medical Histo
ry Term:RIGHT KNEE DEGE
NERATION
Start Date: Apr/UNK/2014
Ongoing: NO
End Date:
Apr/UNK/2014Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795199
Page 103 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.l Line/MH Number:
Date Location User Value Reason
Sep-05-2020 16:40:51
(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-05-2020 16:40:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHT KNEE DEGENERATIONInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-05-2020 16:40:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/UNK/2014Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-05-2020 16:40:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Apr/UNK/2014Initial Entry
1.m
Date Location User Value Reason
Sep-05-2020 17:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:13
Medical Hi
story Term
:RIGHT EYE CLOU
DING MEMBRANE
Start Date: Aug/31/2020
Ongoing: NO
End Date:
Aug/31/2020Transcription Error
Sep-05-2020 17:45:37
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu 13Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795200
Page 104 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada) mber:
Medical Histo
ry Term:right eye clouding
membrane
Start Date: Aug/31/2020
Ongoing: NO
End Date:
Aug/31/2020
1.m Line/MH Number:
Date Location User Value Reason
Sep-05-2020 17:45:37
(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-05-2020 17:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHT EYE CLOUDING MEMB
RANETranscription Error
Sep-05-2020 17:45:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
right eye clouding membraneInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-05-2020 17:45:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-05-2020 17:45:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/31/2020Initial Entry
1.n
Date Location User Value Reason
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795201
Page 105 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-05-2020 17:47:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:14
Medical H
istory Ter
m:RIGHT EYE CAPSULOT
OMY LASER PROCEDU
RE
Start Date
:Aug/31/2020
Ongoing: NO
End Date:
Aug/31/2020Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795202
Page 106 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.n Line/MH Number:
Date Location User Value Reason
Sep-05-2020 17:47:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 16:12:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 2: Closed Response satisfies
query
Sep-16-2020 15:36:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered per Investigator
Progress notes, no
significant changes in
health
Sep-06-2020 09:30:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 2: Opened GPD Clin: Right eye
capsulotomy is
reported on 31Aug.
Per IC #3, MH
condition must be
stable at least 6
weeks before
enrollment. Please
confirm subject
meets eligibility per
IC#3, else document
deviation on I/E CRF
and report deviation
as applicable.
Sep-06-2020 09:29:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed unnecessary query
Sep-06-2020 09:25:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened Left eye capsulotomy
is reported on 31Aug.
Per IC #3, medical
history condition
must be stable at
least 6 weeks before
enrollment. Please
confirm subject
meets eligibility per
IC#3, else document
deviation on I/E CRF
and report deviation
as applicable.
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0795203
Page 107 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-05-2020 17:47:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHT EYE CAPSULOTOMY L
ASER PROCEDUREInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-05-2020 17:47:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-05-2020 17:47:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/31/2020Initial Entry
1.o
Date Location User Value Reason
Sep-05-2020 17:47:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:15
Medical Hist
ory Term:LEFT EYE CLOUDIN
G MEMBRANE
Start Date: Aug/17/2020
Ongoing: NO
End Date:
Aug/17/2020Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795204
Page 108 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.o Line/MH Number:
Date Location User Value Reason
Sep-05-2020 17:47:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-05-2020 17:47:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFT EYE CLOUDING MEMBR
ANEInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-05-2020 17:47:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-05-2020 17:47:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/17/2020Initial Entry
1.p
Date Location User Value Reason
Sep-05-2020 17:48:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:16
Medical His
tory Term:LEFT EYE CAPSULOT
OMY PROCEDURE
Start Date: Aug/17/2020
Ongoing: NO
End Date:
Aug/17/2020Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795205
Page 109 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.p Line/MH Number:
Date Location User Value Reason
Sep-05-2020 17:48:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 16:11:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Sep-16-2020 15:39:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered per Investigator
Progress Notes, no
significant change in
health
Sep-06-2020 09:22:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: Left eye
capsulotomy is
reported on 17Aug.
Per IC #3, MH
condition must be
stable at least 6
weeks before
enrollment. Please
confirm subject
meets eligibility per
IC#3, else document
deviation on I/E CRF
and report deviation
as applicable.
Sep-05-2020 17:48:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFT EYE CAPSULOTOMY PR
OCEDUREInitial Entry
1.p Start Date:
Date Location User Value Reason
Sep-05-2020 17:48:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
1.p Ongoing:
Date Location User Value Reason
Sep-05-2020 17:48:28 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0795206
Page 110 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central Time
(US & Canada)NO
End Date:
Aug/17/2020
1.q
Date Location User Value Reason
Sep-05-2020 17:48:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 17
Medical History Te
rm:SULFA ALLER
GY
Start Date: UNK/UNK/200
5
Ongoing: YESInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795207
Page 111 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.q Line/MH Number:
Date Location User Value Reason
Sep-05-2020 17:48:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-05-2020 17:48:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SULFA ALLERGYInitial Entry
1.q Start Date:
Date Location User Value Reason
Sep-05-2020 17:48:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.q Ongoing:
Date Location User Value Reason
Sep-05-2020 17:48:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.r
Date Location User Value Reason
Sep-29-2020 14:16:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:18
Medical Hist
ory Term:BENIGN TUMOR L
OWER BACK
Start Date: Jun/UNK/2020
Ongoing: NO
End Date:
Jun/UNK/2020Changed Information
(DELETED)
Sep-05-2020 17:49:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:18Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795208
Page 112 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Medical Hist
ory Term:BENIGN TUMOR L
OWER BACK
Start Date: Jun/UNK/2020
Ongoing: NO
End Date:
Jun/UNK/2020
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795209
Page 113 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.r Line/MH Number:
Date Location User Value Reason
Sep-29-2020 14:16:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
18Changed Information
(DELETED)
Sep-05-2020 17:49:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020 14:16:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BENIGN TUMOR LOWER BAC
KChanged Information
(DELETED)
Sep-05-2020 17:49:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BENIGN TUMOR LOWER BAC
KInitial Entry
1.r Start Date:
Date Location User Value Reason
Sep-29-2020 14:16:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2020Changed Information
(DELETED)
Sep-05-2020 17:49:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2020Initial Entry
1.r Ongoing:
Date Location User Value Reason
Sep-29-2020 14:16:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jun/UNK/2020Changed Information
(DELETED)
Sep-05-2020 17:49:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jun/UNK/2020Initial Entry
1.s
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (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) (4), (b)
(6)
FDA-CBER-2021-5683-0795210
Page 114 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-05-2020 17:49:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 19
Medical History Ter
m:ACID REFLU
X
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
1.s Line/MH Number:
Date Location User Value Reason
Sep-05-2020 17:49:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-05-2020 17:49:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ACID REFLUXInitial Entry
1.s Start Date:
Date Location User Value Reason
Sep-05-2020 17:49:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.s Ongoing:
Date Location User Value Reason
Sep-05-2020 17:49:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.t
Date Location User Value Reason
Sep-05-2020 17:50:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:20
Medical Hist
ory Term:BENIGN PROSTATIC
HYPERPLASIAInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795211
Page 115 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Start Date: UNK/UNK/2017
Ongoing: YES
1.t Line/MH Number:
Date Location User Value Reason
Sep-05-2020 17:50:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
20Initial Entry
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-05-2020 17:50:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BENIGN PROSTATIC HYPERPL
ASIAInitial Entry
1.t Start Date:
Date Location User Value Reason
Sep-05-2020 17:50:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.t Ongoing:
Date Location User Value Reason
Sep-05-2020 17:50:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.u
Date Location User Value Reason
Sep-05-2020 17:51:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:21
Medical Hist
ory Term:BILATERAL VISUA
L IMPAIRMENT
Start Date: UNK/UNK/1948
Ongoing: YESInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795212
Page 116 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.u Line/MH Number:
Date Location User Value Reason
Sep-05-2020 17:51:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
21Initial Entry
1.u Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-05-2020 17:51:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BILATERAL VISUAL IMPAIRM
ENTInitial Entry
1.u Start Date:
Date Location User Value Reason
Sep-05-2020 17:51:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1948Initial Entry
1.u Ongoing:
Date Location User Value Reason
Sep-05-2020 17:51:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.v
Date Location User Value Reason
Sep-05-2020 17:51:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:22
Medical History
Term:SEASONAL ALL
ERGIES
Start Date: UNK/UNK/1948
Ongoing: YESInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795213
Page 117 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.v Line/MH Number:
Date Location User Value Reason
Sep-05-2020 17:51:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22Initial Entry
1.v Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-05-2020 17:51:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SEASONAL ALLERGIESInitial Entry
1.v Start Date:
Date Location User Value Reason
Sep-05-2020 17:51:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1948Initial Entry
1.v Ongoing:
Date Location User Value Reason
Sep-05-2020 17:51:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.w
Date Location User Value Reason
Sep-05-2020 17:52:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:23
Medical Histo
ry Term:BILATERAL EYE C
ATARACTS
Start Date: Jan/UNK/2019
Ongoing: NO
End Date:
Jan/UNK/2019Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795214
Page 118 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.w Line/MH Number:
Date Location User Value Reason
Sep-05-2020 17:52:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23Initial Entry
1.w Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-05-2020 17:52:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BILATERAL EYE CATARACTSInitial Entry
1.w Start Date:
Date Location User Value Reason
Sep-05-2020 17:52:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2019Initial Entry
1.w Ongoing:
Date Location User Value Reason
Sep-05-2020 17:52:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jan/UNK/2019Initial Entry
1.x
Date Location User Value Reason
Sep-05-2020 17:53:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:24
Medical His
tory Term:BILATERAL EYE CAT
ARACT SURGERY
Start Date: Jan/UNK/2019
Ongoing: NO
End Date:
Jan/UNK/2019Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795215
Page 119 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.x Line/MH Number:
Date Location User Value Reason
Sep-05-2020 17:53:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24Initial Entry
1.x Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-05-2020 17:53:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BILATERAL EYE CATARACT S
URGERYInitial Entry
1.x Start Date:
Date Location User Value Reason
Sep-05-2020 17:53:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2019Initial Entry
1.x Ongoing:
Date Location User Value Reason
Sep-05-2020 17:53:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jan/UNK/2019Initial Entry
1.y
Date Location User Value Reason
Dec-07-2020 13:40:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 25
Medical History Ter
m:GLAUCOMA
Start Date: UNK/UNK/20
19
Ongoing: YESInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795216
Page 120 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.y Line/MH Number:
Date Location User Value Reason
Dec-07-2020 13:40:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25Initial Entry
1.y Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-07-2020 13:40:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
GLAUCOMAInitial Entry
1.y Start Date:
Date Location User Value Reason
Dec-07-2020 13:40:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.y Ongoing:
Date Location User Value Reason
Dec-07-2020 13:40:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.z
Date Location User Value Reason
Dec-07-2020 13:43:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:26
Medical Histo
ry Term:CORONARY ARTE
RY DISEASE
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795217
Page 121 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.z Line/MH Number:
Date Location User Value Reason
Dec-07-2020 13:43:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
26Initial Entry
1.z Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-07-2020 13:43:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CORONARY ARTERY DISEASEInitial Entry
1.z Start Date:
Date Location User Value Reason
Dec-07-2020 13:43:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.z Ongoing:
Date Location User Value Reason
Dec-07-2020 13:43:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.aa
Date Location User Value Reason
Dec-07-2020 13:44:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 27
Medical History Te
rm:HYPERLIPIDE
MIA
Start Date: UNK/UNK/2005
Ongoing: YESInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795218
Page 122 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.aa Line/MH Number:
Date Location User Value Reason
Dec-07-2020 13:44:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27Initial Entry
1.aa Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-07-2020 13:44:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HYPERLIPIDEMIAInitial Entry
1.aa Start Date:
Date Location User Value Reason
Dec-07-2020 13:44:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.aa Ongoing:
Date Location User Value Reason
Dec-07-2020 13:44:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.ab
Date Location User Value Reason
Dec-07-2020 13:44:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 28
Medical History Ter
m:HYPERTENSI
ON
Start Date: UNK/UNK/200
5
Ongoing: YESInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795219
Page 123 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.ab Line/MH Number:
Date Location User Value Reason
Dec-07-2020 13:44:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28Initial Entry
1.ab Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-07-2020 13:44:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HYPERTENSIONInitial Entry
1.ab Start Date:
Date Location User Value Reason
Dec-07-2020 13:44:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.ab Ongoing:
Date Location User Value Reason
Dec-07-2020 13:44:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.ac
Date Location User Value Reason
Dec-07-2020 13:44:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 29
Medical History Ter
m:ANEMIA
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795220
Page 124 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.ac Line/MH Number:
Date Location User Value Reason
Dec-07-2020 13:44:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29Initial Entry
1.ac Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-07-2020 13:44:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ANEMIAInitial Entry
1.ac Start Date:
Date Location User Value Reason
Dec-07-2020 13:44:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.ac Ongoing:
Date Location User Value Reason
Dec-07-2020 13:44:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.ad
Date Location User Value Reason
Dec-07-2020 13:45:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 30
Medical History Ter
m:ACUTE COLIT
IS
Start Date: UNK/UNK/201
8
Ongoing: YESInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795221
Page 125 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.ad Line/MH Number:
Date Location User Value Reason
Dec-07-2020 13:45:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30Initial Entry
1.ad Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-07-2020 13:45:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ACUTE COLITISInitial Entry
1.ad Start Date:
Date Location User Value Reason
Dec-07-2020 13:45:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.ad Ongoing:
Date Location User Value Reason
Dec-09-2020 09:48:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Response satisfies query
Dec-08-2020 13:58:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered NO EVIDENCE OF
STEROID OR
IMMUNOSUPPRESSANT
THERAPIES NOTED IN
THE MEDICAL
RECORDS FOR PAST
TWO YEARS. NOT IN
CURRENT CARE PLAN
OR CONMEDS.
Dec-08-2020 12:15:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: The subject
presents at screening with
ACUTE COLITIS. Please
confirm that participant is
or is not currently
receiving/plans to receive
oral or parenteral
corticosteroids and/or
immunosuppressants due
to this ongoing condition.
Thanks
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795222
Page 126 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Dec-07-2020 13:45:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.ae
Date Location User Value Reason
Dec-07-2020 13:45:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:31
Medical His
tory Term:ELEVATED PROSTAT
E SPECIFIC ANTIGEN
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
1.ae Line/MH Number:
Date Location User Value Reason
Dec-07-2020 13:45:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
31Initial Entry
1.ae Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-07-2020 13:45:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ELEVATED PROSTATE SPECIFIC A
NTIGENInitial Entry
1.ae Start Date:
Date Location User Value Reason
Dec-07-2020 13:45:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.ae Ongoing:
Date Location User Value Reason
Dec-07-2020 13:45:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.af
Date Location User Value Reason
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795223
Page 127 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Dec-07-2020 13:46:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:32
Medical History
Term:ATRIAL FIBRILL
ATION
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
1.af Line/MH Number:
Date Location User Value Reason
Dec-07-2020 13:46:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
32Initial Entry
1.af Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-07-2020 13:46:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ATRIAL FIBRILLATIONInitial Entry
1.af Start Date:
Date Location User Value Reason
Dec-07-2020 13:46:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.af Ongoing:
Date Location User Value Reason
Dec-07-2020 13:46:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.ag
Date Location User Value Reason
Dec-07-2020 13:46:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:33
Medical History
Term:SICK SINUS SYN
DROME
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795224
Page 128 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.ag Line/MH Number:
Date Location User Value Reason
Dec-07-2020 13:46:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
33Initial Entry
1.ag Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-07-2020 13:46:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SICK SINUS SYNDROMEInitial Entry
1.ag Start Date:
Date Location User Value Reason
Dec-07-2020 13:46:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.ag Ongoing:
Date Location User Value Reason
Dec-09-2020 09:46:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed closed based on site's
clarification
Dec-08-2020 13:59:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered PER MEDICAL
RECORD, THIS IS
LOCATED IN THE
ACTIVE PROBLEM
LIST FOR MOST
RECENT MEDICAL
RECORDS
Dec-08-2020 12:26:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: Can you
please confirm SICK
SINUS SYNDROME
was ongoing at the
time of enrollemnt?
Per data on MH eCRF
page pacemaker
placement occurred in
Aug 2018. Thanks
Dec-07-2020 13:46:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795225
Page 129 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.ah
Date Location User Value Reason
Dec-07-2020 13:46:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:34
Medical Histo
ry Term:CHRONIC THROMB
OCYTOPENIA
Start Date: Jul/UNK/2001
Ongoing: YESInitial Entry
1.ah Line/MH Number:
Date Location User Value Reason
Dec-07-2020 13:46:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
34Initial Entry
1.ah Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-09-2020 09:47:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Response satisfies query
Dec-08-2020 14:01:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered PLATELET COUNT IS
ON THE LOW SIDE OF
NORMAL. NOT
CLINICALLY
SIGNIFICANT PER
INVESTIGATOR.
Dec-08-2020 12:19:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: The subject
presents at screening with
ongoing CHRONIC
THROMBOCYTOPENIA.
Please confirm subject
meets eligibility per
exclusion criterion #10;
else, document deviation
on I/E CRF and report
deviation as applicable.
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0795226
Page 130 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.ah Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-07-2020 13:46:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHRONIC THROMBOCYTOPENIAInitial Entry
1.ah Start Date:
Date Location User Value Reason
Dec-07-2020 13:46:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/UNK/2001Initial Entry
1.ah Ongoing:
Date Location User Value Reason
Dec-07-2020 13:46:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.ai
Date Location User Value Reason
Dec-07-2020 13:47:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:35
Medical History
Term:MYCARDIAL INF
ARCT
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/200
1Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795227
Page 131 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.ai Line/MH Number:
Date Location User Value Reason
Dec-07-2020 13:47:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35Initial Entry
1.ai Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-07-2020 13:47:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MYCARDIAL INFARCTInitial Entry
1.ai Start Date:
Date Location User Value Reason
Dec-07-2020 13:47:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.ai Ongoing:
Date Location User Value Reason
Dec-07-2020 13:47:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2001Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795228
Page 132 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-05-2020 17:54:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-05-2020 17:54:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
186.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-05-2020 17:54:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-05-2020 17:54:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
67.3Initial Entry
5. Unit:
Date Location User Value Reason
Sep-05-2020 17:54:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-05-2020 17:54:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28.9Initial Entry
7.a
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0795229
Page 133 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-05-2020 17:54:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 96.3
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-05-2020 17:54:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-16-2020 03:03:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-15-2020 12:48:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered per Investigator,
clinically not
significant
Sep-07-2020 07:20:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Kindly confirm
if the temp is
clinically significant
or not. If clinically
significant, report an
AE accordingly on
the AE page. Thank
you.
Sep-05-2020 17:55:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Sep-05-2020 17:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 96.3 F
is outside of Normal
Range 97 - 99.5 F.
Sep-05-2020 17:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
96.3Initial Entry
7.a Unit:
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0795230
Page 134 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-05-2020 17:54:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-05-2020 17:54:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795231
Page 135 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-05-2020 17:56:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-05-2020 17:56:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
244992Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795232
Page 136 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-05-2020 17:56:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-05-2020 17:56:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-05-2020 17:56:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-05-2020 17:56:16
(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.
Sep-05-2020 17:56:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Sep-05-2020 17:57:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
5.a
Date Location User Value Reason
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795233
Page 137 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-05-2020 17:56:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM8YCZInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-05-2020 17:56:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM8YCZInitial Entry
5.b
Date Location User Value Reason
Sep-05-2020 17:56:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM8YD0Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-05-2020 17:56:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM8YD0Initial Entry
5.c
Date Location User Value Reason
Sep-05-2020 17:56:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM8YD1Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-05-2020 17:56:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM8YD1Initial Entry
5.d
Date Location User Value Reason
Sep-05-2020 17:57:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRV19Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0795234
Page 138 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Sep-05-2020 17:57:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPRV19Initial Entry
5.e
Date Location User Value Reason
Sep-05-2020 17:57:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRV1BInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-05-2020 17:57:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPRV1BInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795235
Page 139 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-05-2020 17:58:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-05-2020 17:58:12
(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-05-2020 17:58:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-05-2020 17:58:12
(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-05-2020 17:58:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-05-2020 17:58:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP58P2Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0795236
Page 140 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-05-2020 17:58:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP58P2Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795237
Page 141 of 172
***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: 11171088 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-05-2020 17:58:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-05-2020 17:58:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-05-2020 17:58:48
(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-05-2020 17:58:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 16:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-05-2020 17:58:48
(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-05-2020 17:58:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795238
Page 142 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-05-2020 17:58:48
(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-05-2020 17:58:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-05-2020 17:58:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0795239
Page 143 of 172
***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: 11171088 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-05-2020 17:58:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795240
Page 144 of 172
***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: 11171088 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-26-2020 04:43:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Sep-26-2020 04:26:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Sep-25-2020 14:12:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: Answered Original value is
correct
Sep-25-2020 08:09:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: Opened DM: Kindly review
and complete
‘Vaccination, Vital
Signs' forms at this
visit. Thank you.
Sep-24-2020 18:01:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answered Original value is
correct
Sep-24-2020 02:10:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Reissued:Opened DM: Please confirm if
visit was performed.
If entered in error
please consider to tick
the Erroneous visit on
item #2 an clear the
assessments entered in
this visit.
Sep-23-2020 15:47:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Changed Information
Sep-23-2020 15:47:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Changed Information
Sep-23-2020 03:40:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opened Visit is entered in
error as per response
to previous query.
Thus, please select
response to Erroneous
visit and update
details once visit is
performed.
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (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), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0795241
Page 145 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-23-2020 03:38:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Sep-22-2020 15:30:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered VISIT DATE
ENTERED IN
ERROR. FIELD
NEEDS TO BE
CLEARED AND
FORM RESET.
Sep-21-2020 05:16:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened PDQ: DOV at this
visit is out of window
(-19 day) from DOV
(03/Sep/2020) at
V1D1VX1L. Please
reconcile and update
accordingly, else
confirm date is correct
as is.
Sep-21-2020 05:15:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Raised other query
Sep-21-2020 03:41:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened PDQ: DOV at this
visit is out of window
(-19 day) from DOV
(3/SEP/2020) at
V1D1VX1L. Please
either update DOV or
confirm whether visit
is out of window due
to temporary delay of
vaccination/ else
provide details as
appropriate.
Sep-18-2020 10:22:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Oct-06-2020 16:14:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Oct-06-2020 01:08:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Not required now
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795242
Page 146 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-05-2020 08:21:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Please untick the
"erroneous" radio
button as visit is
completed now. Else,
clarify in query
response.
Sep-25-2020 14:11:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Sep-18-2020 10:23:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-18-2020 10:22:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795243
Page 147 of 172
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020 14:12:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-25-2020 14:12:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.9
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-25-2020 14:12:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-25-2020 14:12:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
97.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-25-2020 14:12:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-25-2020 14:12:33
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795244
Page 148 of 172
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(US & Canada)
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795245
Page 149 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 15:46:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 15:46:45
(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-23-2020 15:47:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-23-2020 15:47:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Sep-23-2020 15:46:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-23-2020 15:46:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of Collection
23/Sep/2020 is greater
than Date of Visit
03/Sep/2020. Please
review and update as
appropriate, else
clarify.
Sep-23-2020 15:46:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795246
Page 150 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-06-2020 16:14:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Oct-06-2020 01:08:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Not required now
Oct-05-2020 08:21:22
(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-23-2020 15:46:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Sep-23-2020 15:47:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM8YN1Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-23-2020 15:47:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM8YN1Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795247
Page 151 of 172
***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: 11171088 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-25-2020 14:13:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020 14:13:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020 14:13:13
(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-25-2020 14:13:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020 14:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020 14:13:13
(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-25-2020 14:13:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795248
Page 152 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-25-2020 14:13:13
(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-25-2020 14:13:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-25-2020 14:13:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795249
Page 153 of 172
***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: 11171088 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-27-2020 19:06:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795250
Page 154 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 12:24:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 12:24:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 12:25:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 12:24:52
(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-22-2020 12:24:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020 12:25:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRSRPLInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 12:25:01 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795251
Page 155 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central Time
(US & Canada)BRSRPL
5.b
Date Location User Value Reason
Oct-22-2020 12:25:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRSRPMInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020 12:25:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BRSRPMInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020 12:35:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP58WPInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020 12:35:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP58WPInitial Entry
5.d
Date Location User Value Reason
Oct-22-2020 12:35:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP58WRInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-22-2020 12:35:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP58WRInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(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)
FDA-CBER-2021-5683-0795252
Page 156 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.e
Date Location User Value Reason
Oct-22-2020 12:35:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP58WSInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-22-2020 12:35:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP58WSInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795253
Page 157 of 172
***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: 11171088 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
Oct-27-2020 19:06:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-27-2020 19:06:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-27-2020 19:06:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795254
Page 158 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Nov-25-2020 20:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795255
Page 159 of 172
***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, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Nov-25-2020 20:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-25-2020 20:45:04
(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 ValueReason
Feb-03-2021
11:50:44
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedUpdated terms match
Jan-28-2021
08:30:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Rei
ssued:
Candi
datePending SDB update
Jan-26-2021
18:31:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredREFAXED 26JAN2021
Jan-25-2021
16:51:44
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query
3: Clo
sedThank you for your
response. This query will be
addressed by CRA.
Jan-24-2021
21:27:46ACV0PFEINFP6000 Query
2: ReiSAE RECON: Per PSSR
comment last Jan 6, The
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0795256
Page 160 of 172
***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, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00)
Central Time
(US &
Canada)ssued:
Opene
dreported event on the SAE
form was "Chest pain with
observation admission. A
new updated SAE form is
needed to makeany changes
in the Safety DB. Please
submit a follow up form
Jan-22-2021
09:26:20
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Ans
weredOriginal value is correct
Jan-22-2021
09:26:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredUPDATED SAE FORM
WAS FAXED IN ON
03DEC2020.
Jan-08-2021
06:00:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dSAE RECON 2: Please
confirm if a follow up AEM
form was submitted to
Pfizer Safety to update term
to non cardiac chest pain
Jan-06-2021
10:07:38
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query
3: Rei
ssued:
Opene
dWould you kindly provide
final diagnosis from
discharge summary?
Jan-04-2021
03:37:53
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Rei
ssued:
Candi
datePending SDB update
Dec-31-2020
17:49:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredUPDATE PREVIOUSLY
SUBMITTED TO ICON
PERSONNEL FOR ISSUE
RESOLUTION.
Dec-31-2020
02:21:22
(UTC-06:00)ACV0PFEINFP6000 Query
2: Rei
ssued:SAE RECON 1: The term
in Safety database was
recorded as 'chest pain with
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (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) (4)
FDA-CBER-2021-5683-0795257
Page 161 of 172
***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, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Central Time
(US &
Canada)Opene
dobservation admission'.
Please submit a follow up
AEM form to update term
in SDB.
Dec-28-2020
22:01:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Ans
weredOriginal value is correct
Dec-28-2020
22:00:50
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredOriginal value is correct
Dec-14-2020
21:56:17
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query
3: Op
enedPer case report AER#
202046590, the subject had
tests results “clinically and
electrocardiographically
negative for ischemia.” and
it has been considered a
non-cardiac chest pain.
Kindly clarify specific
diagnosis provided at
discharge. Thank you.
Dec-09-2020
06:13:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Op
enedSAE
RECON:AER#2020465905,
the term in AE CRF was
updated to NON CARDIAC
CHEST PAIN while
retained as chest pain with
observation admission in
SDB. Please confirm
correct term. If safety
update is required, please
submit a follow-up form.
Dec-07-2020
12:44:27
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NON
CAR
DIAC
CHES
T PAI
NNew Information
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0795258
Page 162 of 172
***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, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Dec-02-2020
08:39:12
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedmanually coded
Nov-26-2020
02:38:48
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
1: Op
enedMultiple concepts in the
term CHEST PAIN WITH
OBSERVATION
ADMISSION. Split the
term into CHEST PAIN and
MEDICAL
OBSERVATION and submit
separately. Thank you.
Nov-25-2020
20:45:04
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
CHES
T PAI
N WI
TH O
BSER
VATI
ON A
DMIS
SIONInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-25-2020 20:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/14/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-25-2020 20:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/16/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-25-2020 20:45:04 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795259
Page 163 of 172
***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, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central Time
(US & Canada)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).
Date Location User Value Reason
Nov-26-2020 05:12:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-26-2020 01:06:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened For AE CHEST PAIN
WITH
OBSERVATION
ADMISSION:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Nov-25-2020 20:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE CHEST PAIN
WITH
OBSERVATION
ADMISSION:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Nov-25-2020 20:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
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 proInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795260
Page 164 of 172
***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, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
long hospitalization?
YES
Did this serious event result in persi
stent or significant disability/incapa
city?
NO
Is this serious event life threatening
?
NO
Other medically important serious e
vent
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.
Date Location User Value Reason
Nov-25-2020 20:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-25-2020 20:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
PRIOR CARDIAC MEDICAL
HISTORYInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-25-2020 20:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795261
Page 165 of 172
***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, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-25-2020 20:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-25-2020 20:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-25-2020 20:45:04
(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?
Date Location User Value Reason
Nov-25-2020 20:45:04
(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
Nov-26-2020 05:12:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2020465905Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795262
Page 166 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Jan-12-2021 20:33:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795263
Page 167 of 172
***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, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171088 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
Jan-12-2021 20:33:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Jan-12-2021 20:33:52
(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
Jan-12-2021 20:33:52
(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
Jan-12-2021 20:33:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FLU VACCINEInitial Entry
5. Date:
Date Location User Value Reason
Jan-12-2021 20:33:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795264
Page 168 of 172
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-28-2020 17:45:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/17/2020Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795265
Page 169 of 172
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-31-2020 04:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-29-2020 21:09:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Dec-29-2020 01:58:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Dec-28-2020 17:45:53
(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.
Dec-28-2020 17:45:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for V
accination 3
Participant is:
eligible and NOT confirmed to h
ave received only placebo at Vac
cination 1/2Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0795266
Page 170 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-29-2020 21:26:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/17/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-29-2020 21:26:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR ADDITI
ONAL VACCINATIONInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795267
Page 171 of 172
***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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-27-2020 19:06:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-05-2020 17:56:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-05-2020 16:32:17
(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-26-2020 05:13:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Nov-25-2020 20:49:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per query
Nov-25-2020 05:45:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020465905
chest pain with observation
admission(onset
date:14Nov2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-27-2020 19:06:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
Sep-05-2020 17:56:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/3/2020Initial Entry
Sep-05-2020 16:32:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/3/2020Initial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795268
Page 172 of 172
***Confidential***
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: 11171088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-30-2020 16:42:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3dc6\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0795269