Document text
Page 1 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828317
Page 2 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/24/2020
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828318
Page 3 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12241065]
2.Birth Date: /1990
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828319
Page 4 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828320
Page 5 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828321
Page 6 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828322
Page 7 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Acne]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828323
Page 8 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
2.Weight: [144.0]
3.Unit: LB
4.Height: [67.1]
5.Unit: in
6.Body Mass Index: [22.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828324
Page 9 of 217
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/24/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828325
Page 10 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/24/2020
2.Randomization Number: [60712]
3.Randomization Group: [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828326
Page 11 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BNWLWC]
5.bSample ID [BNWLWD]
5.cSample ID [BPYMVJ]
5.dSample ID [BPYMVK]
5.eSample ID [BPYMVL]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828327
Page 12 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BPYMKH]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828328
Page 13 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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/24/2020 10:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828329
Page 14 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828330
Page 15 of 217
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828331
Page 16 of 217
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828332
Page 17 of 217
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828333
Page 18 of 217
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828334
Page 19 of 217
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828335
Page 20 of 217
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828336
Page 21 of 217
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828337
Page 22 of 217
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828338
Page 23 of 217
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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: [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828339
Page 24 of 217
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828340
Page 25 of 217
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828341
Page 26 of 217
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828342
Page 27 of 217
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828343
Page 28 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828344
Page 29 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828345
Page 30 of 217
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/10/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828346
Page 31 of 217
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/10/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828347
Page 32 of 217
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/10/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Sep/10/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Site staff followed up with pt over the phone regarding AE outcomes and pt desire
to discontinue the trial.]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828348
Page 33 of 217
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/5/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT Comments
4.Specify Status: [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828349
Page 34 of 217
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Not Applicable
//Comments
2.Phase of Disposition: Not Applicable Comments
3.Status: Not Applicable Comments
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828350
Page 35 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828351
Page 36 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828352
Page 37 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828353
Page 38 of 217
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828354
Page 39 of 217
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828355
Page 40 of 217
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828356
Page 41 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828357
Page 42 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828358
Page 43 of 217
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828359
Page 44 of 217
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828360
Page 45 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828361
Page 46 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/1/2021
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828362
Page 47 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828363
Page 48 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/1/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828364
Page 49 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/1/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828365
Page 50 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/1/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1RT1]
5.bSample ID [BNWMD2]
5.cSample ID [BNWMD3]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828366
Page 51 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/1/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRG6BJ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828367
Page 52 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/1/2021 14:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828368
Page 53 of 217
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828369
Page 54 of 217
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/22/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828370
Page 55 of 217
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/22/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRG6DL]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828371
Page 56 of 217
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/22/2021 10:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828372
Page 57 of 217
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/22/2021
2.Erroneous Visit
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828373
Page 58 of 217
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/22/2021
3.Comments: [Site contacted subject; no changes in health or meds reported; no use of prohibited
conmeds; no vaccines to report. eDiary and subject reminders reviewed.]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828374
Page 59 of 217
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828375
Page 60 of 217
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828376
Page 61 of 217
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828377
Page 62 of 217
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828378
Page 63 of 217
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828379
Page 64 of 217
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EV
ENT 1 Fatigue Aug/24/2020 UNK:
UNK NO
End Date Time:
Sep/2/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Feverish Chills Aug/24/2020 UNK:
UNK NO
End Date Time:
Sep/2/2020 UNK:UNK
Repeating
Pages
3.ADVERSE EV
ENT 3 Irregular Heart Rate Aug/24/2020 UNK:
UNK NO
End Date Time:
Sep/10/2020 UNK:UNK
Repeating
Pages
4.ADVERSE EV
ENT 4 Diarrhea Aug/24/2020 UNK:
UNK NO
End Date Time:
Sep/6/2020 UNK:UNK
Repeating
Pages
5.ADVERSE EV
ENT 5 Increased Blood Pre
ssure Aug/24/2020 UNK:
UNK NO
End Date Time:
Sep/10/2020 UNK:UNK
Repeating
Pages
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828380
Page 65 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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)[Fatigue]
4.Start Date Time: Aug/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/2/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
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
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828381
Page 66 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828382
Page 67 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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)[Feverish Chills]
4.Start Date Time: Aug/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/2/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828383
Page 68 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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[ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828384
Page 69 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Irregular Heart Rate]
4.Start Date Time: Aug/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/10/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828385
Page 70 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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[ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828386
Page 71 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Diarrhea]
4.Start Date Time: Aug/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/6/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828387
Page 72 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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[ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828388
Page 73 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Increased Blood Pressure]
4.Start Date Time: Aug/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/10/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828389
Page 74 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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[ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828390
Page 75 of 217
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828391
Page 76 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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[ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828392
Page 77 of 217
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828393
Page 78 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828394
Page 79 of 217
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828395
Page 80 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828396
Page 81 of 217
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828397
Page 82 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828398
Page 83 of 217
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828399
Page 84 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828400
Page 85 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/1/2021 Comments
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION Comments
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828401
Page 86 of 217
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828402
Page 87 of 217
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828403
Page 88 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/5/2020
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828404
Page 89 of 217
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828405
Page 90 of 217
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Larry Odekirk Approved Mar-24-2021 09:28:51 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LarryOdekirk, 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.
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828406
Page 91 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormAug-25-2020 09:39:31 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828407
Page 92 of 217
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - Comments
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormFeb-17-2021 11:13:19 (UTC-07:00) Mountain
Time (US & Canada)Subject previously withdrew consent to trial
participation due to Adverse Event. Following
release of blinding information, the subject
re-consented to complete trial participation.
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828408
Page 93 of 217
***Confidential***
Header Text: C4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Sep-15-2020 12:05:33 (UTC-07:00) Mountain
Time (US & Canada)Pt chose to withdraw consent from trial
participation due to onset of AEs.
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828409
Page 94 of 217
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormFeb-17-2021 11:36:59 (UTC-07:00) Mountain
Time (US & Canada)Subject previously withdrew consent to trial
participation due to Adverse Event. Following
release of blinding information, the subject
re-consented to complete trial participation.
Not Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828410
Page 95 of 217
***Confidential***
Header Text: C4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Feb-17-2021 11:36:59 (UTC-07:00) Mountain
Time (US & Canada)Subject previously withdrew consent to trial
participation due to Adverse Event. Following
release of blinding information, the subject
re-consented to complete trial participation.
Not Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828411
Page 96 of 217
***Confidential***
Header Text: C4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Feb-17-2021 11:36:59 (UTC-07:00) Mountain
Time (US & Canada)Subject previously withdrew consent to trial
participation due to Adverse Event. Following
release of blinding information, the subject
re-consented to complete trial participation.
Not Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828412
Page 97 of 217
***Confidential***
Header Text: C4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Feb-17-2021 11:36:59 (UTC-07:00) Mountain
Time (US & Canada)Subject previously withdrew consent to trial
participation due to Adverse Event. Following
release of blinding information, the subject
re-consented to complete trial participation.
Not Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828413
Page 98 of 217
***Confidential***
Header Text: C4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Feb-17-2021 11:36:59 (UTC-07:00) Mountain
Time (US & Canada)Subject previously withdrew consent to trial
participation due to Adverse Event. Following
release of blinding information, the subject
re-consented to complete trial participation.
Not Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828414
Page 99 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormFeb-12-2021 13:21:56 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828415
Page 100 of 217
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormFeb-16-2021 11:34:19 (UTC-07:00) Mountain
Time (US & Canada)
FormSep-15-2020 12:02:00 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828416
Page 101 of 217
***Confidential***
Header Text: C4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Feb-16-2021 11:34:19 (UTC-07:00) Mountain
Time (US & Canada)
1Sep-15-2020 12:02:00 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828417
Page 102 of 217
***Confidential***
Header Text: C4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Feb-16-2021 11:34:19 (UTC-07:00) Mountain
Time (US & Canada)
2Sep-15-2020 12:02:00 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828418
Page 103 of 217
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormFeb-17-2021 11:31:38 (UTC-07:00) Mountain
Time (US & Canada)Subject previously withdrew consent to trial
participation due to Adverse Event. Following
release of blinding information, the subject
re-consented to complete trial participation.
Not Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828419
Page 104 of 217
***Confidential***
Header Text: C4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Feb-17-2021 11:31:38 (UTC-07:00) Mountain
Time (US & Canada)Subject previously withdrew consent to trial
participation due to Adverse Event. Following
release of blinding information, the subject
re-consented to complete trial participation.
Not Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828420
Page 105 of 217
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-15-2020 12:03:45 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828421
Page 106 of 217
***Confidential***
Header Text: C4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Sep-15-2020 12:03:45 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828422
Page 107 of 217
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Larry Odekirk Approved Mar-24-2021 09:28:51 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LarryOdekirk, 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 Mar-23-2021 14:11:00 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Larry Odekirk Approved Mar-10-2021 11:36:37 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LarryOdekirk, 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 Feb-12-2021 13:20:49 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Larry Odekirk Approved Nov-12-2020 10:32:27 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828423
Page 108 of 217
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, LarryOdekirk, 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-11-2020 09:13:00 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Larry Odekirk Approved Oct-26-2020 09:40:11 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LarryOdekirk, 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 Oct-22-2020 11:22:48 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Larry Odekirk Approved Oct-21-2020 14:21:43 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LarryOdekirk, 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.
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828424
Page 109 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-24-2020 13:31:42
(UTC-07:00) Mountain
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-24-2020 13:31:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828425
Page 110 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-25-2020 09:38:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-25-2020 09:37:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date Informed
Consent Obtained is
not the same as the
Date of Visit. Please
correct as necessary.
Aug-24-2020 13:31:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/24/2020Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828426
Page 111 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-24-2020 13:31:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12241065Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-24-2020 13:31:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1990Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-24-2020 13:32:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-24-2020 13:32:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-24-2020 13:32:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828427
Page 112 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-25-2020 09:38:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-25-2020 09:38:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Transcription Error
Aug-25-2020 09:37:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of Visit is before
the Date Written
Consent Obtained.
Please review and
update as appropriate.
Aug-25-2020 09:37:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828428
Page 113 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-25-2020 09:39:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020 09:39:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-25-2020 09:39:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828429
Page 114 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Aug-25-2020 09:40:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:Acne
Start Date: UNK/UNK/20
17
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020 09:40:20
(UTC-07:00) Mountain
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-25-2020 09:40:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AcneInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-25-2020 09:40:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-25-2020 09:40:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828430
Page 115 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828431
Page 116 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020 09:41:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020 09:41:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
144.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020 09:41:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-25-2020 09:41:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
67.1Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020 09:41:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828432
Page 117 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
6. Body Mass Index:
Date Location User Value Reason
Aug-25-2020 09:41:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.5Initial Entry
7.a
Date Location User Value Reason
Aug-25-2020 09:41:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 99.4
Temperature Unit: F
Temperature Locatio
n::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020 09:41:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020 09:41:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
99.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020 09:41:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828433
Page 118 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020 09:41:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828434
Page 119 of 217
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-25-2020 09:41:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-25-2020 09:41:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-25-2020 09:41:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-25-2020 09:41:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-25-2020 09:41:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-25-2020 09:41:24
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828435
Page 120 of 217
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Time (US & Canada) Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-25-2020 09:41:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-25-2020 09:41:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-25-2020 09:41:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828436
Page 121 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-25-2020 09:41:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020 09:41:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
60712Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828437
Page 122 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 13:47:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 13:47:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020 13:48:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-25-2020 13:47:50
(UTC-07:00) Mountain
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-25-2020 13:47:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-22-2020 15:16:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed No need to query as
per SPA
Oct-22-2020 11:22:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered corrected for query
resolution
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0828438
Page 123 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-22-2020 11:22:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry: corrected for query
resolution
Oct-20-2020 13:39:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: A carriage is
identified. To avoid
processing errors,
please remove the
identified character
by deleting the entry
and re-entering the
data (without using
copy and paste).
Aug-25-2020 13:48:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020 13:48:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWLWCInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-25-2020 13:48:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWLWCInitial Entry
5.b
Date Location User Value Reason
Aug-25-2020 13:48:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWLWDInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828439
Page 124 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.b Sample ID
Date Location User Value Reason
Aug-25-2020 13:48:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWLWDInitial Entry
5.c
Date Location User Value Reason
Aug-25-2020 13:48:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYMVJInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-25-2020 13:48:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYMVJInitial Entry
5.d
Date Location User Value Reason
Aug-25-2020 13:49:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYMVKInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828440
Page 125 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.d Sample ID
Date Location User Value Reason
Aug-25-2020 13:49:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYMVKInitial Entry
5.e
Date Location User Value Reason
Aug-25-2020 13:49:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYMVLInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-25-2020 13:49:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYMVLInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828441
Page 126 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 13:49:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 13:49:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020 00:27:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Sep-21-2020 12:22:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Samples were
collected at time of
visit; Data entry
transcription error in
entering the dates has
been corrected.
Sep-19-2020 08:43:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM1: kindly verify
and update the reason
for If no sample was
collected or sample
was not collected
according to protocol
its still not updated.
Sep-18-2020 08:39:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Sep-18-2020 08:39:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Transcription Error
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828442
Page 127 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-18-2020 02:06:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM: Form is in
unfrozen state. Please
update data as per
below query.
Sep-17-2020 09:29:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Please unfreeze form;
this is a transcription
error
Sep-17-2020 01:58:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Nasal Swab sample
is collected after
Vaccination 1,
however response to
“If no sample was
collected or sample
was not collected
according to
protocol, please
provide reason:" is
missing. Please
update.
Aug-25-2020 13:51:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-25-2020 13:49:43
(UTC-07:00) Mountain
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-25-2020 13:49:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020 13:51:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYMKHInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828443
Page 128 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a Sample ID
Date Location User Value Reason
Aug-25-2020 13:51:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYMKHInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828444
Page 129 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-25-2020 09:42:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020 09:42:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020 09:42:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-25-2020 09:42:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020 10:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020 09:42:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828445
Page 130 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-25-2020 09:42:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-25-2020 09:42:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-25-2020 09:42:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-25-2020 09:42:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828446
Page 131 of 217
***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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-25-2020 09:42:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828447
Page 132 of 217
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/10/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-19-2020 09:33:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Sep-15-2020 12:43:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Date is correct as entered;
site followed up for AEs
that were unresolved.
Sep-15-2020 12:05:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of Visit is after the
Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
Sep-15-2020 11:58:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/10/2020Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828448
Page 133 of 217
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/10/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Assessments
Date Location User Value Reason
Sep-15-2020 12:01:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 11:59:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update as
appropriate.
Sep-15-2020 11:59:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828449
Page 134 of 217
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/10/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Contact Type:
Date Location User Value Reason
Sep-15-2020 12:01:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Sep-15-2020 12:01:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Sep/10/2020
Contact Outcome:
VISIT NOT REQUIRED, INVES
TIGATOR DECISIONInitial Entry
3. Comments:
Date Location User Value Reason
Sep-15-2020 12:01:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Site staff followed up with pt over th
e phone regarding AE outcomes and
pt desire to discontinue the trial.Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828450
Page 135 of 217
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-18-2021 12:43:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-18-2021 12:42:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Initial Entry
Feb-18-2021 12:42:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/5/2020Initial Entry
Feb-17-2021 23:09:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: Please complete
this form. Thank
you.
Feb-17-2021 11:06:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Changed Information
Nov-13-2020 01:55:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted AE #3
Nov-10-2020 21:33:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Candidate Once the site picked
a primary AE for
Drug Withdrawal
and Discont. please
ensure that this date
is within the duration
of the AE start and
stop date. Thank you.
Sep-15-2020 12:04:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/5/2020Initial Entry
2. Phase of Disposition:
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828451
Page 136 of 217
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Feb-18-2021 12:42:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
Feb-17-2021 11:06:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Changed Information
Sep-15-2020 12:04:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Feb-18-2021 12:42:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTInitial Entry
Feb-17-2021 11:12:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Changed Information
Sep-15-2020 12:04:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828452
Page 137 of 217
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-18-2021 05:51:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Feb-17-2021 22:07:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies query
Feb-17-2021 11:36:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-17-2021 11:15:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Form has been cleared
intentionally. Subject
previously withdrew
consent to trial participation
due to Adverse Event.
Following release of
blinding information, the
subject re-consented to
complete trial participation.
Feb-17-2021 11:15:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Form has been cleared.
Subject previously
withdrew consent to trial
participation due to Adverse
Event. Following release of
blinding information, the
subject re-consented to
complete trial participation.
Feb-17-2021 05:06:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened If this form is meant to be
cleared, kindly remove data
entered at field named
'Status'. Or clarify.
Feb-16-2021 23:39:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened DM: Please complete this
item or else clarify. Thank
you.
Feb-16-2021 11:37:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Updated
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828453
Page 138 of 217
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Feb-16-2021 11:37:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Updated
Feb-15-2021 10:36:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Rivkah Rosen Query 2: Reissued:Opened DM: Unblinding forms
have been unfrozen.
Feb-12-2021 13:20:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered These items are still frozen;
Please fully open the forms
for update. thank you
Feb-12-2021 08:25:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened The Disposition forms have
been unfrozen.
Feb-11-2021 18:42:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Please unfreeze disposition
forms for editing; subject
has contacted site for
unblinding.
Feb-09-2021 03:46:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM : Date of visit is
recorded as 10/Sep/2020 on
DOV - Unscheduled Visit .
Therefore, Please review
and confirm whether this
date to be updated for Date
of
Completion/Discontinuation
/Death. Kindly review and
update. Else, clarify.
Feb-08-2021 08:04:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Subject withdrew consent to
study participation on
05Sep2020; and provided
the clinic with follow-up
information regarding AEs
on the 10th.
Feb-04-2021 23:15:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 2: Opened Subject was contacted to
follow up on the AE as per
unplanned visit on
10Sep2020. Please review
and confirm whether this
date to be updated as
10Sep2020. Else clarify.
Nov-11-2020 13:37:16
(UTC-07:00) MountainACV0PFEINFP6000 Query 1: Closed Response satisfies query
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828454
Page 139 of 217
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Time (US & Canada)
Nov-11-2020 09:18:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Primary AE has been
selected; discontinuation
date falls within duration of
primary event.
Nov-10-2020 21:33:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Once the site picked a
primary AE for Drug
Withdrawal and Discont.
please ensure that this date
is within the duration of the
AE start and stop date.
Thank you.
Sep-15-2020 12:05:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-17-2021 11:36:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Feb-16-2021 11:37:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Updated
Sep-15-2020 12:05:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Feb-17-2021 11:36:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-17-2021 11:15:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Changed Information
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828455
Page 140 of 217
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-15-2020 12:05:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTInitial Entry
4. Specify Status:
Date Location User Value Reason
Feb-17-2021 11:36:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828456
Page 141 of 217
***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, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User ValueReason
Feb-18-2021
12:43:37
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
3: Clo
sedResponse satisfies query
Feb-17-2021
23:28:24
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedexisting query for
DISPOSITION -
FOLLOW-UP form to be
cleared.
Feb-17-2021
20:39:41
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
3: Op
enedDMW7288598;DOV is
entered for Revax Contact
but Disposition Treatment
at END_OF_TRT visit is
null. Please review and
update as appropriate.
Feb-17-2021
11:14:53
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredDisposition Follow Up has
been addressed. Subject
previously withdrew
consent to trial participation
due to Adverse Event.
Following release of
blinding information, the
subject re-consented to
complete trial participation.
Feb-16-2021
21:53:48
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM : Thanks for response.
However, only status is
entered on DISPOSITION -
FOLLOW-UP CRF. Please
review and update the data
as appropriate. Else, clarify.
Feb-16-2021
20:25:07
(UTC-07:00)
Mountain
Time (US &ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Clo
sedAuto closed by Validation
Check: VC_SV001_04_AN
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828457
Page 142 of 217
***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, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Canada)
Feb-16-2021
11:35:46
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredForms have been updated
Feb-16-2021
11:35:33
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredForms have been updated
Feb-14-2021
22:48:58
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dFUP DISPOSITION form is
now unfrozen. Please
proceed with update.
Feb-12-2021
20:02:22
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Op
enedDMW7250282;‘Date of
Visit' is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Feb-12-2021
14:00:17
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredDisposition form is
currently frozen. Please
unfreeze for updates
Feb-12-2021
13:20:49
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Op
enedDate of Visit is after the
Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
Feb-12-2021
13:20:49
(UTC-07:00)
Mountain
Time (US &ACV0PFEINFP6000 Data
Entry
:
Feb/1/
2021Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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)
FDA-CBER-2021-5683-0828458
Page 143 of 217
***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, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Canada)
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828459
Page 144 of 217
***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, Locked, Frozen
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-16-2021 11:34:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-14-2021 22:53:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Madhan Babu Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Feb-12-2021 13:21:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Feb-12-2021 13:21:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national reco
mmendations and confirmed to
have received only placebo at V
accination 1/2Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828460
Page 145 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User ValueReason
Feb-17-2021
22:07:20
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Feb-17-2021
11:16:14
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredFUP has been addressed
Feb-17-2021
04:00:02
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dSubject has rejoined the
study. Please clear all data
entered from the FUP
DISPOSITION form
accordingly. Or clarify.
Feb-16-2021
20:25:07
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Clo
sedAuto closed by Validation
Check: VC_SV001_04_AN
Feb-16-2021
11:36:13
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredForms have been updated
Feb-16-2021
11:36:04
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredForms have been updated
Feb-15-2021
09:30:30ACV0PFEINFP6000 Query
1: ReiDM: Form unfrozen, Please
update per query response
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828461
Page 146 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-07:00)
Mountain
Time (US &
Canada)ssued:
Opene
dprovided.
Feb-12-2021
20:02:22
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Op
enedDMW7250286;‘Date of
Visit' is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Feb-12-2021
13:23:50
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredUnable to update until data
has unfrozen all disposition
forms
Feb-12-2021
13:21:18
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Op
enedDate of Visit is after the
Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
Feb-12-2021
13:21:18
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Feb/1/
2021Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828462
Page 147 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-12-2021 13:21:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/1/2021Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828463
Page 148 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-12-2021 13:22:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/1/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-12-2021 13:22:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-12-2021 13:22:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828464
Page 149 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-12-2021 13:22:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-12-2021 13:22:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User ValueReason
Feb-16-2021
20:25:07
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_LB001_05_AN
Feb-16-2021
11:36:37
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredForms have been updated
Feb-12-2021
19:53:32
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7250186;‘Collection
Date' is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition
<- Follow-up> eCRF.
Please clarify or correct.
Feb-12-2021
13:22:24
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Feb/1/
2021Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828465
Page 150 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-12-2021 13:22:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-12-2021 13:22:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Feb-12-2021 13:22:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Feb-12-2021 13:22:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-12-2021 13:22:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828466
Page 151 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Feb-12-2021 13:22:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828467
Page 152 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-12-2021 13:25:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-12-2021 13:25:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-12-2021 13:25:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-12-2021 13:25:44
(UTC-07:00) Mountain
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.
Feb-12-2021 13:25:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/1/2021Initial Entry
5.a
Date Location User Value Reason
Feb-12-2021 13:25:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1RT1Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828468
Page 153 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a Sample ID
Date Location User Value Reason
Feb-12-2021 13:25:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1RT1Initial Entry
5.b
Date Location User Value Reason
Feb-12-2021 13:26:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWMD2Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-12-2021 13:26:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWMD2Initial Entry
5.c
Date Location User Value Reason
Feb-12-2021 13:26:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWMD3Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-12-2021 13:26:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWMD3Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828469
Page 154 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-12-2021 13:25:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-12-2021 13:25:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-12-2021 13:25:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-12-2021 13:25:13
(UTC-07:00) Mountain
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.
Feb-12-2021 13:25:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/1/2021Initial Entry
5.a
Date Location User Value Reason
Feb-12-2021 13:25:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRG6BJInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828470
Page 155 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a Sample ID
Date Location User Value Reason
Feb-12-2021 13:25:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRG6BJInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828471
Page 156 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-12-2021 13:24:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-12-2021 13:24:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-12-2021 13:24:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-12-2021 13:24:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/1/2021 14:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-12-2021 13:24:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828472
Page 157 of 217
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Feb-12-2021 13:24:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-12-2021 13:24:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-12-2021 13:24:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-12-2021 13:24:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-12-2021 13:24:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Feb-12-2021 13:24:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828473
Page 158 of 217
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021 11:57:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/22/2021Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828474
Page 159 of 217
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-23-2021 11:57:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-23-2021 11:57:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-23-2021 11:57:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/22/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-23-2021 11:57:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-23-2021 11:57:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Feb-23-2021 11:57:24
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828475
Page 160 of 217
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Time (US & Canada) Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Feb-23-2021 11:57:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-23-2021 11:57:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Feb-23-2021 11:57:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828476
Page 161 of 217
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-24-2021 14:39:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-24-2021 14:39:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-24-2021 14:39:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-24-2021 14:39:29
(UTC-07:00) Mountain
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.
Feb-24-2021 14:39:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/22/2021Initial Entry
5.a
Date Location User Value Reason
Feb-24-2021 14:39:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRG6DLInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828477
Page 162 of 217
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a Sample ID
Date Location User Value Reason
Feb-24-2021 14:39:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRG6DLInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828478
Page 163 of 217
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-23-2021 11:58:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-23-2021 11:58:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-23-2021 11:58:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-23-2021 11:58:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/22/2021 10:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-23-2021 11:58:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828479
Page 164 of 217
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Feb-23-2021 11:58:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-23-2021 11:58:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-23-2021 11:58:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-23-2021 11:58:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-23-2021 11:58:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Feb-23-2021 11:58:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828480
Page 165 of 217
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-23-2021 14:11:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/22/2021Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828481
Page 166 of 217
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-23-2021 14:12:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-23-2021 14:12:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Mar/22/2021Initial Entry
3. Comments:
Date Location User Value Reason
Mar-23-2021 14:12:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Site contacted subject; no changes in
health or meds reported; no use of pr
ohibited conmeds; no vaccines to rep
ort. eDiary and subject reminders rev
iewed.Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828482
Page 167 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Sep-15-2020 11:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828483
Page 168 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828484
Page 169 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Sep-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828485
Page 170 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Sep-15-2020 11:54:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828486
Page 171 of 217
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Sep-15-2020 11:56:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828487
Page 172 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Sep-15-2020 11:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-15-2020 11:39:00
(UTC-07:00) Mountain
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-15-2020 11:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FatigueInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-17-2020 02:43:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as per site
confirmation
Sep-16-2020 11:39:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered AE reported after
treatment visit; pt
did not provide a
specified onset time.
Sep-16-2020 05:37:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Please check
with subject and
confirm if AE
started before or
after vaccination.
Thank you.
Sep-15-2020 11:39:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject did not
specify time of AE
start
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828488
Page 173 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-15-2020 11:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Fatigue:
Start Date is the
same as a
Vaccination Date,
but time is not
provided. Please
review and update
as appropriate.
Sep-15-2020 11:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000
)Data Entry:
Aug/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-15-2020 11:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/2/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-15-2020 11:39:00
(UTC-07:00) Mountain
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
Sep-15-2020 11:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828489
Page 174 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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-15-2020 11:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-15-2020 11:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-11-2020 13:33:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-11-2020 09:13:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Per query resolution
Nov-11-2020 09:13:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEPer query resolution
Nov-10-2020 21:26:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Only one primary
Adverse Event should
be chosen to have
question 'LATEST
ACTION TAKEN
WITH STUDY
DRUG' that would
indicate DRUG
WITHDRAWN.
Multiple are selected
at this time, please
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828490
Page 175 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
select ONLY Primary
Adverse Event.
Sep-15-2020 11:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-15-2020 11:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-15-2020 11:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-15-2020 11:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-11-2020 13:33:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-11-2020 09:14:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Correction per query
resolution
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828491
Page 176 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-11-2020 09:14:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOCorrection per query
resolution
Nov-10-2020 21:29:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Only one primary
Adverse Event should
be chosen to have
question 'Did the
adverse event cause
the subject to be
discontinued from the
study? answered as
YES if applicable.
Please chose Primary
Adverse Event.
Sep-15-2020 12:05:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 11:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Did the adverse event
cause the subject to
be discontinued from
the study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Sep-15-2020 11:39:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828492
Page 177 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
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
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feverish ChillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-17-2020 02:43:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as per site
confirmation
Sep-16-2020 11:40:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered AE reported after
treatment visit; pt
did not provide a
specified onset time.
Sep-16-2020 05:38:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Thanks for
the response. Please
confirm if AE was
started before or
after vaccination.
Sep-15-2020 11:50:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Pt did not provide
the time of AE
beginning
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828493
Page 178 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Feverish
Chills: Start Date is
the same as a
Vaccination Date,
but time is not
provided. Please
review and update
as appropriate.
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/2/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
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
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828494
Page 179 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-11-2020 13:35:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-11-2020 09:14:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Correction per query
resolution
Nov-11-2020 09:14:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLECorrection per query
resolution
Nov-10-2020 21:26:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Only one primary
Adverse Event should
be chosen to have
question 'LATEST
ACTION TAKEN
WITH STUDY
DRUG' that would
indicate DRUG
WITHDRAWN.
Multiple are selected
at this time, please
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828495
Page 180 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
select ONLY Primary
Adverse Event.
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-11-2020 13:34:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Nov-11-2020 09:14:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Correction per query
resolution
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828496
Page 181 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-11-2020 09:14:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOCorrection per query
resolution
Nov-10-2020 21:29:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened Only one primary
Adverse Event
should be chosen to
have question 'Did
the adverse event
cause the subject to
be discontinued from
the study? answered
as YES if applicable.
Please chose Primary
Adverse Event.
Sep-19-2020 04:02:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Sep-17-2020 09:31:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Site has
correspondence
directly from subject
stating her choice to
withdrawn from the
trial because of
events occurring.
This documentation
is in subject file.
Sep-17-2020 07:18:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM2: Please confirm
if, in the opinion of
PI, this event cause
the subject
discontinuation from
the study. Thanks
Sep-16-2020 11:42:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered PT chose to
withdraw consent
due to combination
of AEs, all with
onset after first
treatment visit.
Sep-16-2020 05:41:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM1: Only one 1
AE should cause
discontinuation from
study. Please review
and update response
for appropriate AE;
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828497
Page 182 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
else clarify.
Sep-15-2020 12:05:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 11:52:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Original value is
correct
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened More than 1 AE for
this patient has "Did
the adverse event
cause the subject to
be discontinued from
the study?" marked
as 'Yes'.
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Did the adverse
event cause the
subject to be
discontinued from
the study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as
''ADVERSE
EVENT''. Please
review and update as
appropriate.
Sep-15-2020 11:50:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828498
Page 183 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Sep-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Irregular Heart RateInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-17-2020 02:44:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as per site
confirmation
Sep-16-2020 11:40:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered AE reported after
treatment visit; pt
did not provide a
specified onset time.
Sep-16-2020 05:40:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Thanks for
the response. Please
confirm if AE was
started before or
after vaccination.
Sep-15-2020 11:53:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered pt did not provide
start time of event
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828499
Page 184 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Irregular
Heart Rate: Start
Date is the same as a
Vaccination Date,
but time is not
provided. Please
review and update
as appropriate.
Sep-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User ValueReason
Feb-17-2021
01:00:40
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
4: Clo
sedResponse satisfies query
Feb-16-2021
11:36:59
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
4: Ans
weredDisposition has been
updated
Feb-16-2021
06:01:50
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
4: Op
enedDISP F/U
DATE=05Sep2020 but AE
END DATE=10Sep2020.
Since AE END DATE
cannot be > than DISP F/U
DATE, please consider
changing AE to "Ongoing"
(at the time of DISP F/U)
OR enter AE END DATE
that is < DISP F/U DATE
OR fix DISP F/U DATE to
be > AE END DATE.
Feb-16-2021
06:01:24
(UTC-07:00)
MountainACV0PFEINFP6000 Query
3: Clo
sedNeed to rewrite query.
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828500
Page 185 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Time (US &
Canada)
Feb-16-2021
05:54:54
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
3: Op
enedDISP F/U
DATE=06Sep2020 but AE
END DATE=10Sep2020.
Since AE END DATE
cannot be > than DISP F/U
DATE, please consider
changing AE to "Ongoing"
(at the time of DISP F/U)
OR enter AE END DATE
that is < DISP F/U DATE
OR fix DISP F/U DATE to
be > AE END DATE.
Feb-16-2021
05:45:02
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedWill write another
(hopefully clearer) query.
Feb-15-2021
09:29:02
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Rei
ssued:
Candi
datePlease update when data is
available, per query
response
Feb-15-2021
06:46:19
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Clo
seddata looks correct as subject
is under re-vaccination.
Feb-11-2021
18:43:36
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredsubject status pending
update
Feb-11-2021
18:42:20
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredSubject status pending other
update.
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828501
Page 186 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Feb-11-2021
01:28:40
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dDM: No Data expected to
enter post FUP date. Either
FUP date or else mark AE
as ongoing at the time of
FUP visit. Thank you.
Feb-09-2021
02:03:32
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM: No Data expected to
enter post FUP visit. Please
verify and consider
updating dates as
appropriate. Thank you.
Feb-08-2021
08:02:42
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredDate entered is when
subject provided end of date
to symptoms. Follow up
contact occurred after the
contact when the subject
withdrew consent.
Feb-08-2021
08:02:24
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredDate entered is when
subject provided end of date
to symptoms. Follow up
contact occurred after the
contact when the subject
withdrew consent.
Feb-07-2021
22:21:25
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dSubject was contacted to
follow up on AE as per
unplanned visit on
10Sep2020. Please review
and confirm whether
DISPOSITION FUP date to
be updated as 10Sep2020.
Else clarify.
Feb-07-2021
22:00:07
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dDM: Date cannot be before
FUP date. Please verify and
consider updating data as
appropriate or else clarify.
Thank you.
Feb-07-2021
15:51:09
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredOriginal value is correct
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828502
Page 187 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Feb-07-2021
15:50:59
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredOriginal value is correct
Feb-03-2021
02:32:38
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Op
enedDMW4704974;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Feb-03-2021
01:57:00
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Balaji Prabu R Query
1: Op
ened‘End Date' is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Sep-15-2020
11:53:23
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NO
End
Date
Tim
e:
Se
p/1
0/2
02
0
U
N
K:
U
N
KInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828503
Page 188 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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-15-2020 11:53:23
(UTC-07:00) Mountain
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-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-11-2020 13:36:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-11-2020 09:16:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Site will use this as
primary AE for
discontinuation and
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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)
FDA-CBER-2021-5683-0828504
Page 189 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
drug withdrawal.
Nov-10-2020 21:27:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Only one primary
Adverse Event should
be chosen to have
question 'LATEST
ACTION TAKEN
WITH STUDY
DRUG' that would
indicate DRUG
WITHDRAWN.
Multiple are selected
at this time, please
select ONLY Primary
Adverse Event.
Sep-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828505
Page 190 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-27-2021 13:44:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 4: Closed Response satisfies
query
Feb-26-2021 13:21:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Answered PT previously
withdrew from trial
due to AE. Chose to
unblind and resume
participation.
Feb-26-2021 13:21:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOPT previously
withdrew from trial
due to AE. Chose to
unblind and resume
participation.
Feb-25-2021 03:52:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened CLINQUERY: Per
comment at FUP
page it appears
subject has resumed
participation in the
study post unblind. If
correct, please update
this entry in line with
the change to the
FUP page.
Feb-23-2021 04:11:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 4: Candidate CLINQUERY: Per
comment at FUP
page it appears
subject has resumed
participation in the
study post unblind. If
correct, please update
this entry in line with
the change to the
FUP page.
Nov-11-2020 13:37:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Nov-11-2020 09:17:21
(UTC-07:00) MountainACV0PFEINFP6000 Query 3: Answered Site has chosen this
for primary
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828506
Page 191 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Time (US & Canada)
Nov-10-2020 21:30:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened Only one primary
Adverse Event should
be chosen to have
question 'Did the
adverse event cause
the subject to be
discontinued from the
study? answered as
YES if applicable.
Please chose Primary
Adverse Event.
Sep-19-2020 04:04:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828507
Page 192 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-17-2020 09:32:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Site has
correspondence
directly from subject
stating her choice to
withdrawn from the
trial because of
events occurring.
This documentation
is in subject file.
Sep-17-2020 07:18:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM2: Please confirm
if, in the opinion of
PI, this event cause
the subject
discontinuation from
the study. Thanks
Sep-16-2020 11:42:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered PT chose to withdraw
consent due to
combination of AEs,
all with onset after
first treatment visit.
Sep-16-2020 06:24:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM1: Only one 1 AE
should cause
discontinuation from
study. Please review
and update response
for appropriate AE;
else clarify.
Sep-15-2020 12:05:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 11:53:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Original value is
correct
Sep-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened More than 1 AE for
this patient has "Did
the adverse event
cause the subject to
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828508
Page 193 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
be discontinued from
the study?" marked
as 'Yes'.
Sep-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Did the adverse
event cause the
subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Sep-15-2020 11:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828509
Page 194 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Sep-15-2020 11:54:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-15-2020 11:54:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-15-2020 11:54:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DiarrheaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-17-2020 02:00:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed closing as per site
confirmation
Sep-16-2020 11:40:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered AE reported after
treatment visit; pt did
not provide a
specified onset time.
Sep-16-2020 06:22:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Thanks for the
response. Please
confirm if AE was
started before or after
vaccination.
Sep-15-2020 11:55:00
(UTC-07:00) MountainACV0PFEINFP6000 Query 1: Answered Pt did not provide
start time of event
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828510
Page 195 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Time (US & Canada)
Sep-15-2020 11:54:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Diarrhea:
Start Date is the
same as a
Vaccination Date, but
time is not provided.
Please review and
update as
appropriate.
Sep-15-2020 11:54:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User ValueReason
Feb-11-2021
06:35:32
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedClosed other query
available at FU-DISP form
for same reason.
Feb-08-2021
08:02:57
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredDate entered is when
subject provided end of date
to symptoms. Follow up
contact occurred after the
contact when the subject
withdrew consent.
Feb-07-2021
23:22:29
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedResponse satisfies query
Feb-07-2021
22:22:07
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dSubject was contacted to
follow up on AE as per
unplanned visit on
10Sep2020. Please review
and confirm whether
DISPOSITION FUP date to
be updated as 10Sep2020.
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0828511
Page 196 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Else clarify.
Feb-07-2021
15:51:48
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredOriginal value is correct
Feb-07-2021
15:51:38
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredOriginal value is correct
Feb-03-2021
02:33:03
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Op
enedDMW4704975;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Feb-03-2021
01:57:16
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Balaji Prabu R Query
1: Op
ened‘End Date' is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Sep-15-2020
11:54:41
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NO
End
Date
Tim
e:
Se
p/6
/20
20
U
N
K:
U
N
KInitial Entry
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828512
Page 197 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
6. Toxicity Grade:
Date Location User Value Reason
Sep-15-2020 11:54:41
(UTC-07:00) Mountain
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
Sep-15-2020 11:54:41
(UTC-07:00) Mountain
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-15-2020 11:54:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-15-2020 11:54:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3e40\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828513
Page 198 of 217
***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
Site No: 1224 Site Name: (1224) Lynn Institute of Denver
Subject No: 12241065 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-11-2020 13:37:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-11-2020 09:15:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Correction per query
resolution
Nov-11-2020 09:15:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLECorrection per query
resolution
Nov-10-2020 21:27:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Only one primary
Adverse Event should
be chosen to have
question 'LATEST
ACTION TAKEN
WITH STUDY
DRUG' that would
indicate DRUG
WITHDRAWN.
Multiple are selected
at this time, please
select ONLY Primary
Adverse Event.
Sep-15-2020 11:54:41
(UTC-07:00) Mountain
Ti
…[truncated]