Document text
Page 1 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022568
Page 2 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/31/2020
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022569
Page 3 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Demography
1.Subject ID [10951180]
2.Birth Date: /1953
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:
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022570
Page 4 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022571
Page 5 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022572
Page 6 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022573
Page 7 of 136
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Knee replacement (left)]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis (left knee)]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2001
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis (right knee)]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vasectomy]
Start Date: UNK/UNK/1986
Ongoing: NO
End Date:
UNK/UNK/1986
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022574
Page 8 of 136
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Atrial Septal Defect]
Start Date: /1953
Ongoing: YES
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022575
Page 9 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [84.6]
3.Unit: kg
4.Height: [173.5]
5.Unit: cm
6.Body Mass Index: [28.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022576
Page 10 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [245978]
3.Randomization Group: [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022577
Page 11 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BPY2WB]
5.bSample ID [BPY2WC]
5.cSample ID [BPY2WD]
5.dSample ID [BPCT3L]
5.eSample ID [BPCT3M]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022578
Page 12 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BP3BHV]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022579
Page 13 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/31/2020 12:08
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
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022580
Page 14 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022581
Page 15 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022582
Page 16 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022583
Page 17 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1N39]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022584
Page 18 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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/22/2020 14:26
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
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022585
Page 19 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022586
Page 20 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BRDFW1]
5.bSample ID [BRDFW2]
5.cSample ID [BRDFW3]
5.dSample ID [BPLJT6]
5.eSample ID [BPLJT7]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022587
Page 21 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022588
Page 22 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022589
Page 23 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022590
Page 24 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022591
Page 25 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022592
Page 26 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022593
Page 27 of 136
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022594
Page 28 of 136
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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: [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022595
Page 29 of 136
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022596
Page 30 of 136
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022597
Page 31 of 136
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022598
Page 32 of 136
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022599
Page 33 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022600
Page 34 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022601
Page 35 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022602
Page 36 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Unplanned Assessments
1.Assessments
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022603
Page 37 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022604
Page 38 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022605
Page 39 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022606
Page 40 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022607
Page 41 of 136
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 post vaccination m
yalgia Aug/31/2020 18:0
0 NO
End Date Time:
Aug/31/2020 23:00
Repeating
Pages
2.ADVERSE EV
ENT 2 Dizziness Nov/5/2020 UNK:
UNK NO
End Date Time:
Nov/6/2020 UNK:UNK
Repeating
Pages
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022608
Page 42 of 136
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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)[post vaccination myalgia]
4.Start Date Time: Aug/31/2020 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/31/2020 23:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022609
Page 43 of 136
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022610
Page 44 of 136
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dizziness]
4.Start Date Time: Nov/5/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/6/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022611
Page 45 of 136
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:
[Atrial Septal Defect]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020448828]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022612
Page 46 of 136
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. [ ] Repeating
Pages
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022613
Page 47 of 136
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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[ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022614
Page 48 of 136
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of MedicationStart D
ateForm Instan
ce
1.1 VACCINATIO
NS NO Influenza vaccine 1 dose IM once
for influenza prophylaxis Oct/13/
2020 Repeating
Pages
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022615
Page 49 of 136
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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).[Influenza vaccine 1 dose IM once for influenza prophylaxis]
5.Date: Oct/13/2020
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022616
Page 50 of 136
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022617
Page 51 of 136
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022618
Page 52 of 136
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022619
Page 53 of 136
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022620
Page 54 of 136
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022621
Page 55 of 136
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022622
Page 56 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022623
Page 57 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022624
Page 58 of 136
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022625
Page 59 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022626
Page 60 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022627
Page 61 of 136
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022628
Page 62 of 136
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022629
Page 63 of 136
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022630
Page 64 of 136
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022631
Page 65 of 136
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022632
Page 66 of 136
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Not Verified, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022633
Page 67 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/30/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022634
Page 68 of 136
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022635
Page 69 of 136
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022636
Page 70 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/20/2020
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022637
Page 71 of 136
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022638
Page 72 of 136
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022639
Page 73 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormAug-31-2020 12:16:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1022640
Page 74 of 136
***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, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-24-2021 08:33:33 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell Approved Jan-25-2021 21:25:14 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulPickrell, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-30-2020 16:58:50 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell Approved Nov-17-2020 19:55:00 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulPickrell, 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.
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022641
Page 75 of 136
***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, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
N/A Nov-16-2020 16:56:36 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell Approved Nov-14-2020 07:25:24 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulPickrell, 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-13-2020 03:34:09 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell Approved Nov-10-2020 21:21:54 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulPickrell, 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-09-2020 17:23:30 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022642
Page 76 of 136
***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, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Paul Pickrell Approved Oct-30-2020 16:29:27 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulPickrell, 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.
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022643
Page 77 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-31-2020 11:34:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-31-2020 11:34:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022644
Page 78 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-31-2020 11:34:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/31/2020Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022645
Page 79 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-31-2020 11:34:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10951180Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020 11:34:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1953Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020 11:34:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-31-2020 11:34:45
(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
Aug-31-2020 11:34:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022646
Page 80 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020 12:16:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022647
Page 81 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-31-2020 12:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020 12:16:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-31-2020 12:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022648
Page 82 of 136
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.a
Date Location User Value Reason
Aug-31-2020 12:17:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:Knee replacemen
t (left)
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2
001Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-31-2020 12:17:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 12:17:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Knee replacement (left)Initial Entry
1.a Start Date:
Date Location User Value Reason
Aug-31-2020 12:17:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-31-2020 12:17:29 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1022649
Page 83 of 136
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central
Time (US & Canada)NO
End Date:
UNK/UNK/2001
1.b
Date Location User Value Reason
Aug-31-2020 12:18:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Osteoarthritis (lef
t knee)
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/20
01Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1022650
Page 84 of 136
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.b Line/MH Number:
Date Location User Value Reason
Aug-31-2020 12:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 12:18:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Osteoarthritis (left knee)Initial Entry
1.b Start Date:
Date Location User Value Reason
Aug-31-2020 12:18:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-31-2020 12:18:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2001Initial Entry
1.c
Date Location User Value Reason
Aug-31-2020 12:18:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:Osteoarthritis (ri
ght knee)
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022651
Page 85 of 136
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.c Line/MH Number:
Date Location User Value Reason
Aug-31-2020 12:18:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 12:18:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Osteoarthritis (right knee)Initial Entry
1.c Start Date:
Date Location User Value Reason
Aug-31-2020 12:18:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-31-2020 12:18:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-31-2020 12:19:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Vasectomy
Start Date: UNK/UNK/198
6
Ongoing: NO
End Date:
UNK/UNK/
1986Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022652
Page 86 of 136
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.d Line/MH Number:
Date Location User Value Reason
Aug-31-2020 12:19:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 12:19:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VasectomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-31-2020 12:19:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1986Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-31-2020 12:19:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1986Initial Entry
1.e
Date Location User Value Reason
Nov-17-2020 15:17:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:5
Medical History
Term:Atrial Septal D
efect
Start Date: 1953
Ongoing: YESchanged start date to
reflect pt's dob since
this is due to
congenital heart
condition at birth
Nov-16-2020 16:57:10
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe 5Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022653
Page 87 of 136
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada) r:
Medical History
Term:Atrial Septal D
efect
Start Date: Nov/5/2020
Ongoing: YES
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022654
Page 88 of 136
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.e Line/MH Number:
Date Location User Value Reason
Nov-16-2020 16:57:10
(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
Nov-16-2020 16:57:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Atrial Septal DefectInitial Entry
1.e Start Date:
Date Location User Value Reason
Nov-17-2020 16:46:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-17-2020 15:17:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto Query
Nov-17-2020 15:17:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
/1953changed start date
to reflect pt's dob
since this is due to
congenital heart
condition at birth
Nov-16-2020 20:59:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: As per
protocol, only AEs
that occur prior to
dosing should be
noted on the
Medical History
CRF. Please
consider moving
this AE to the AE
Log form, or advise.
Nov-16-2020 16:57:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered This is the date the
participant found
out, this is the date
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(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-2021-5683-1022655
Page 89 of 136
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
of the AE and this is
what was instructed
by CRM
Nov-16-2020 16:57:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
31/Aug/2020.
Please review and
update as
appropriate.
Nov-16-2020 16:57:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/5/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Nov-16-2020 16:57:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022656
Page 90 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020 12:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020 12:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
84.6Initial Entry
3. Unit:
Date Location User Value Reason
Aug-31-2020 12:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-31-2020 12:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
173.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-31-2020 12:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-31-2020 12:20:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28.1Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (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-2021-5683-1022657
Page 91 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
7.a
Date Location User Value Reason
Aug-31-2020 12:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-31-2020 12:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-31-2020 12:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-31-2020 12:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-31-2020 12:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (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-2021-5683-1022658
Page 92 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-31-2020 12:20:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-31-2020 12:20:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
245978Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022659
Page 93 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 12:20:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 12:20:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 18:49:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 12:20:48
(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.
Aug-31-2020 12:20:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020 18:49:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY2WBInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022660
Page 94 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.a Sample ID
Date Location User Value Reason
Aug-31-2020 18:49:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY2WBInitial Entry
5.b
Date Location User Value Reason
Aug-31-2020 18:49:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY2WCInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-31-2020 18:49:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY2WCInitial Entry
5.c
Date Location User Value Reason
Aug-31-2020 18:50:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY2WDInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-31-2020 18:50:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY2WDInitial Entry
5.d
Date Location User Value Reason
Aug-31-2020 18:50:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPCT3LInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022661
Page 95 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.d Sample ID
Date Location User Value Reason
Aug-31-2020 18:50:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPCT3LInitial Entry
5.e
Date Location User Value Reason
Aug-31-2020 18:50:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPCT3MInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-31-2020 18:50:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPCT3MInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022662
Page 96 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 12:20:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 12:20:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 18:50:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 12:20:56
(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.
Aug-31-2020 12:20:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020 18:50:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3BHVInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022663
Page 97 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.a Sample ID
Date Location User Value Reason
Aug-31-2020 18:50:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3BHVInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022664
Page 98 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-31-2020 12:21:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020 12:21:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020 12:21:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020 12:21:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020 12:08Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020 12:21:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020 12:21:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022665
Page 99 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
7. Route:
Date Location User Value Reason
Aug-31-2020 12:21:12
(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
Aug-31-2020 12:21:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-31-2020 12:21:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022666
Page 100 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-31-2020 12:21:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022667
Page 101 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-22-2020 14:30:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022668
Page 102 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020 14:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020 14:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.9
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020 14:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-22-2020 14:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-22-2020 14:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (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-2021-5683-1022669
Page 103 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Sep-22-2020 14:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022670
Page 104 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020 14:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 14:35:01
(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-22-2020 18:19:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-22-2020 14:35:01
(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-22-2020 14:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-22-2020 18:19:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1N39Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022671
Page 105 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.a Sample ID
Date Location User Value Reason
Sep-22-2020 18:19:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1N39Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022672
Page 106 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-22-2020 14:31:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020 14:31:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020 14:31:09
(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-22-2020 14:31:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020 14:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020 14:31:09
(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-22-2020 14:31:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022673
Page 107 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
7. Route:
Date Location User Value Reason
Sep-22-2020 14:31:09
(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-22-2020 14:31:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-22-2020 14:31:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022674
Page 108 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020 15:00:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022675
Page 109 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 15:00:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 15:00:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 17:02:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-20-2020 15:00:14
(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-20-2020 15:00:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020 17:02:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRDFW1Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022676
Page 110 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 17:02:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRDFW1Initial Entry
5.b
Date Location User Value Reason
Oct-20-2020 17:02:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRDFW2Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020 17:02:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRDFW2Initial Entry
5.c
Date Location User Value Reason
Oct-20-2020 17:02:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRDFW3Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-20-2020 17:02:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRDFW3Initial Entry
5.d
Date Location User Value Reason
Oct-20-2020 17:16:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLJT6Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022677
Page 111 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.d Sample ID
Date Location User Value Reason
Oct-20-2020 17:16:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPLJT6Initial Entry
5.e
Date Location User Value Reason
Oct-20-2020 17:16:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLJT7Initial Entry
5.e Sample ID
Date Location User Value Reason
Oct-20-2020 17:16:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPLJT7Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022678
Page 112 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-20-2020 15:00:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-20-2020 15:00:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-20-2020 15:00:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022679
Page 113 of 136
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Sep-22-2020 14:36:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022680
Page 114 of 136
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Nov-09-2020 17:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022681
Page 115 of 136
***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, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Sep-22-2020 14:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-22-2020 14:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-22-2020 14:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
post vaccination myalgiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-22-2020 14:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-22-2020 14:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020 18:00Transcription Error
Sep-22-2020 14:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE post
vaccination myalgia:
Start Date is the
same as a
Vaccination Date,
but time is not
provided. Please
review and update as
appropriate.
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022682
Page 116 of 136
***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, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-22-2020 14:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-22-2020 14:41:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/31/2020 23:00Transcription Error
Sep-22-2020 14:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/31/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-22-2020 14:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-22-2020 14:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-22-2020 14:36:55
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(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-2021-5683-1022683
Page 117 of 136
***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, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-22-2020 14:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-22-2020 14:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-22-2020 14:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-22-2020 14:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-22-2020 14:36:55
(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
Sep-22-2020 14:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (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-2021-5683-1022684
Page 118 of 136
***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, Locked, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Nov-09-2020 17:23:30
(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-09-2020 17:23:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-16-2020 17:52:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies query
Nov-16-2020 17:25:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Nov-16-2020 16:56:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered updated
Nov-16-2020 16:56:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered updated
Nov-16-2020 16:56:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dizzinessupdated
Nov-16-2020 13:42:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Safety will continue to work
with site to split terms;
however reporting is
complete
Nov-14-2020 10:43:39
(UTC-06:00) CentralACV0PFEINFP6000 Query 3: Opened SAE
RECON:AER#2020448828,
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (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-2021-5683-1022685
Page 119 of 136
***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, Locked, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada) the term was reported as
'dizziness secondary to
Atrial Septal Defect'. Please
consider to split the term as
separate events to facilitate
coding and match Safety
database.
Nov-13-2020 18:10:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened CLINICAL - One SAE
report can include 2 or more
events, if they are
concurrent; the SAE report
is already coding the 2
events separately
(Neuro/Cardiol). So one
SAE number is sufficient.
Nov-13-2020 16:55:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered to clarify, you are asking for
2 SAE's to be submitted?
Nov-13-2020 16:07:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINCIAL Please submit
clinical course information
including results of ECG
(dizziness) and ECHO/MRI
(ASD).
Nov-13-2020 16:03:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL - Please
separate the 2 terms
Dizziness (related to ASD),
and ASD, for separate
coding in both AE and SAE
safety followup. Please
confirm subject was
previously unaware of ASD
(ie new diagnosis/AE).
Nov-09-2020 17:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
dizziness secondary to Atri
al Septal DefectInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-09-2020 17:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/5/2020 UNK:UNKInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (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-2021-5683-1022686
Page 120 of 136
***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, Locked, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-16-2020 17:25:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-16-2020 16:58:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered This has been
updated
Nov-13-2020 16:05:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL End
date for event of
Dizziness due to
ASD is 06Nov2020;
however, SAE
report has no end
date. Please update
end dates for each
event (Dizziness;
ASD) separately in
AE and SAE safety
update
Nov-09-2020 17:26:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/6/2020 UNK:UNKTranscription Error
Nov-09-2020 17:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-11-2020 10:20:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-10-2020 13:32:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-10-2020 13:32:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Transcription Error
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (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-2021-5683-1022687
Page 121 of 136
***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, Locked, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Nov-10-2020 12:29:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Mild '1' per source.
Please verify and
update, thanks
Nov-09-2020 17:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-13-2020 05:27:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed SDB updated
Nov-11-2020 07:27:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed event missing in
SDB.pending SAE
recon issue
Nov-11-2020 05:34:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Candidate Pending SDB update
Nov-11-2020 00:35:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened For AE dizziness
secondary to Atrial
Septal Defect:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Nov-10-2020 16:20:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 3: Closed Response satisfies
query
Nov-10-2020 13:31:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Candidate For AE dizziness
secondary to Atrial
Septal Defect:
Response to "Is the
adverse event
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (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-2021-5683-1022688
Page 122 of 136
***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, Locked, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Nov-10-2020 13:31:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered updated as requested
Nov-10-2020 13:31:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered updated as requested
Nov-10-2020 13:31:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th 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 disabil
ity/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important seri
ous event
NOupdated as requested
Nov-10-2020 11:37:01 ACV0PFEINFP6000 Quan Jason Query 3: Opened GPDClin: The SAE
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022689
Page 123 of 136
***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, Locked, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central
Time (US & Canada)Gong criterion on
congenital anomaly
or birth defect is to
ask if the event
resulted in a
congenital anomaly
not resulted from a
congenital anomaly.
Please change the
answer to "No" for
this criterion.
Nov-10-2020 07:38:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON:
dizziness secondary
to Atrial Septal
Defect Onset
date:05Nov2020) is
not reported to Safety
database but marked
serious on AE
CRF.Confirm
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Nov-10-2020 07:35:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Missing in SDB.
New query issued
Nov-10-2020 02:33:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened For AE dizziness
secondary to Atrial
Septal Defect:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Nov-09-2020 17:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE dizziness
secondary to Atrial
Septal Defect:
Response to "Is the
adverse event
serious?" is 'Yes' but
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022690
Page 124 of 136
***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, Locked, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
"Serious Adverse
Event Number" is
blank.
Nov-09-2020 17:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
YES
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 disabil
ity/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important seri
ous event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-09-2020 17:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022691
Page 125 of 136
***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, Locked, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Nov-09-2020 17:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
Atrial Septal DefectInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-09-2020 17:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-09-2020 17:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-09-2020 17:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-09-2020 17:23:30
(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
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (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-2021-5683-1022692
Page 126 of 136
***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, Locked, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Nov-09-2020 17:23:30
(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-13-2020 03:34:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020448828Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1022693
Page 127 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Oct-20-2020 15:43:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022694
Page 128 of 136
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-20-2020 15:43:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Oct-20-2020 15:43:37
(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
Oct-20-2020 15:43:37
(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
Oct-20-2020 15:43:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Influenza vaccine 1 dose IM once f
or influenza prophylaxisInitial Entry
5. Date:
Date Location User Value Reason
Oct-20-2020 15:43:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022695
Page 129 of 136
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-30-2020 16:59:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/30/2020Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022696
Page 130 of 136
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Not Verified, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-01-2021 15:49:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Transcription Error
Dec-30-2020 16:59:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willing to ret
urn for Vaccination 3 OR otherw
ise not eligibleInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022697
Page 131 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-30-2020 16:58:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/30/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Mar-02-2021
02:45:15
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Clo
sedSite has updated the
data per query.
Mar-01-2021
15:49:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: An
swere
dChanged data per query
Mar-01-2021
14:57:10
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Rei
ssued:
Opene
dDM RQ: Form has
been unfrozen. Please
review and update
accordingly. Else,
clarify.
Mar-01-2021
10:02:05
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: An
swere
dPlease unfreeze and
re-query.
Mar-01-2021
05:49:47
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedClosed per data
updated.
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022698
Page 132 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Feb-26-2021
16:06:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
3: Op
enedDMW7478490;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Feb-26-2021
09:10:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: An
swere
dTranscription Error
Feb-26-2021
09:10:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
ASSE
SS EL
IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ONTranscription Error
Feb-26-2021
00:25:45
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Op
enedIVRS Reconciliation:
Other is selected as the
primary reason for
unblinding but
matching blind break is
not captured in IRT.
Please correct primary
reason in Inform or
confirm as correct”.
Feb-24-2021 ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY QueryAuto closed by
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022699
Page 133 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
15:52:15
(UTC-06:00)
Central Time
(US &
Canada)1: Clo
sedValidation Check:
VC_DS001_35
Feb-24-2021
08:33:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Feb-24-2021
08:33:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
OTH
ER
If ot
her,
spec
ify:
per
ppf
ize
r u
pd
ateTranscription Error
Feb-24-2021
02:11:21
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM: Form unfrozen,
kindly review and
update.
Feb-23-2021
17:10:48
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dPlease unfreeze and
requery
Feb-22-2021
13:02:01
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7350127;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022700
Page 134 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Canada) VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Dec-30-2020
16:58:50
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
ASSE
SS EL
IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ONInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022701
Page 135 of 136
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject Status
Date Location User Value Reason
Feb-25-2021 14:15:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-08-2021 16:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered SAE Update has
been submitted
Dec-17-2020 14:50:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL Please
submit SAE safety
followup to report
the Med Hx
condition of ASD
(1953 start).
Oct-20-2020 15:00:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-31-2020 12:20:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-31-2020 12:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-20-2020 15:00:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/20/2020Initial Entry
Aug-31-2020 12:20:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
Aug-31-2020 12:16:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022702
Page 136 of 136
***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, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951180 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-30-2020 15:37:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2fb3\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022703