tips to a successful monitoring visit ngoc tran, ccra nt research, inc
TRANSCRIPT
![Page 1: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/1.jpg)
Tips to a Successful Monitoring VisitNgoc Tran, CCRANT Research, Inc.
![Page 2: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/2.jpg)
Study Monitor
Person delegated by the Sponsor to oversee the conduct of a clinical trial by ensuring that study activities are in accordance to the protocol and regulatory requirements.
![Page 3: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/3.jpg)
Roles and Responsibilitie
s
Act as a liaison between Site and Sponsor
Assure rights, safety and well-being of subjects are protected
Review trial data for accuracy, completeness and verifiable
Oversee study activities for protocol, GCP and regulatory compliance
![Page 4: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/4.jpg)
![Page 5: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/5.jpg)
Different but SameChanging mindsets
![Page 6: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/6.jpg)
All for One and One for All
![Page 7: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/7.jpg)
Monitor-Site EncountersId
entify
Pot
ential
Inve
stig
ator
sSite
Eva
luat
ion V
isit
Pre-
Stu
dy
Vis
it
Inve
stig
ator
Mee
ting/ In
itia
tion
Vis
it
Inte
rim
Mon
itor
ing V
isits
Clo
se-o
ut
Vis
it
![Page 8: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/8.jpg)
Site Visits Evaluation/Pre-Study Initiation Monitoring Close-out
![Page 9: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/9.jpg)
Assess Investigator’s interest and qualification
Evaluate Site’s capability to properly and safely conduct clinical trial
Request Investigator and Study Coordinator attendance
Evaluation/Pre-Study Visit PurposeSetting the stage.
![Page 10: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/10.jpg)
Obtain Signed Confidentiality Agreement
Provide protocol synopsis for review
Evaluate by phone or in person
Evaluation/Pre-Study VisitExpectationsMeet & Greet
![Page 11: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/11.jpg)
Preparing for an Evaluation/Pre-Study Visit
Review protocol synopsis Obtain copies of the Investigator’s CV
and credentials Verify that there is sufficient personnel,
resources and necessary equipment to conduct the clinical trial
Assess ability to meet enrollment goals and timelines
Schedule tour of facilities (i.e. pharmacy, lab, etc).
![Page 12: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/12.jpg)
Provide Protocol and Investigational Product/Device Training
Outline expectations of Investigator and research personnel
Confirm study supplies received
Initiation Visit PurposeWhy Initiations are so critical for the Sponsor and the Site to engage in open dialogue.
![Page 13: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/13.jpg)
Collect remaining essential documents
Occurs prior to enrollment commencing
Attendance expected of Investigator and Key Research Personnel
Initiation Visit PurposeWhy Initiations are so critical for the Sponsor and the Site to engage in open dialogue.
![Page 14: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/14.jpg)
Sample of Initiation Agenda Detailed discussion of the protocol, including:
- Overall study design and objective- Study primary and secondary endpoints- Inclusion/Exclusion Criteria- Study Procedures- Drug/Device Administration, Storage, and Handling
Consent and enrollment procedures Adverse event reporting Investigator and research personnel
roles/responsibilities Case report forms (Electronic or Paper) Monitoring frequency & expectations Sponsor specific forms/logs Identify potential problems and concerns
![Page 15: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/15.jpg)
Preparing for Initiation Visit
Review protocol and identify potential challenges and/or concerns for discussion
Become familiar with Sponsor provided documents/forms
Begin maintenance of regulatory files Obtain remaining essential documents Confirm and audit supplies received
![Page 16: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/16.jpg)
Preparing for Initiation Visit
Schedule tour of the site, pharmacy & lab Notify appropriate research personnel Arrange meeting room logistics Start Delegation of Authority Log & Site
Signature Log and Training Log Compare Sponsor forms and Institutional
Forms for similarities/differences
![Page 17: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/17.jpg)
Monitoring Visit Purpose
Review progress of clinical trial and ensure protocol adherence and regulatory compliance while maintaining the rights, safety and well-being of subjects
Frequency is dictated by complexity of the study and Sponsor requirements
Investigator and key research personnel should be available for questions
![Page 18: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/18.jpg)
Monitoring Visit Preparation
Reserve monitoring space which provides access to phone, internet, and copy/fax
Schedule visits with the Investigator, Pharmacy, Laboratory and Regulatory office, if applicable
Request access to medical records/source documents
Complete CRFs Prepare regulatory files Allot time to meet with Monitor to discuss visit
findings
![Page 19: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/19.jpg)
Preparing Source Documents Provide list of subjects
with corresponding medical record number
Orient monitor to medical record layout
Verify all consented subjects have properly completed Informed Consent Forms and process is well documented
Review drug compliance records and reconcile discrepancies
Assure lab, diagnostic and radiology reports are available for review
Flag sections of the chart to ease search of information
Have Investigator or designee document review of laboratory results especially if out-of-range
Ensure deviations or missing information is well documented
![Page 20: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/20.jpg)
Preparing CRFs
Complete CRFs up to visit date Answer queries appropriately Ensure data is accurate and verifiable by
making source documents available Review Adverse Events(AE) being sure that
grade, severity and attribution are assessed and documented
Review concomitant medications for start/stop dates and corresponding AE entry
![Page 21: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/21.jpg)
Preparing Regulatory Files Make sure files are complete and current Retain all versions of the protocol,
Investigator Brochures, laboratory certification, lab normals, FDA Form 1572, CVs, licenses, financial disclosure
File IRB acknowledgement of receipt, if applicable, approval and correspondences
Update signature and enrollment logs Retain Sponsor correspondences
![Page 22: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/22.jpg)
Occurs when study is complete and database is locked
Final review of regulatory files
Reconciliation of IP/Device
Review record retention requirements
Collect IRB notification of study closure
Close-Out Visit Purpose
![Page 23: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/23.jpg)
Close-Out Visit Preparation Secure monitor space/room Provide regulatory files and case books Ensure Investigator and site staff are
available Schedule final pharmacy visit for drug
return Gather unused supplies for
return/destruction
![Page 24: Tips to a Successful Monitoring Visit Ngoc Tran, CCRA NT Research, Inc](https://reader035.vdocument.in/reader035/viewer/2022062417/551689f15503469d698b6168/html5/thumbnails/24.jpg)
Are You Ready?