1. Tips to a Successful Monitoring Visit
Ngoc Tran, CCRA
NT Research, Inc.

2. 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.
Study Monitor

3. Roles and Responsibilities
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
Roles and Responsibilities
Verifies that the investigator has adequate qualified personnel and resources.
Verifies that the facilities, including lab and equipment are adequate to safely and properly conduct the trial.

5. Different but Same
Changing mindsets

6. All for One and One for All

7. Monitor-Site Encounters
Identify Potential Investigators
Site Evaluation Visit
Pre-Study Visit
Investigator Meeting/ Initiation Visit
Interim Monitoring Visits
Close-out Visit

8. Site Visits
Evaluation/Pre-Study
Initiation
Monitoring
Close-out

9. Evaluation/ Pre-Study Visit Purpose
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 Purpose
Setting the stage.

10. Evaluation/ Pre-Study Visit Expectations
Obtain Signed Confidentiality Agreement
Provide protocol synopsis for review
Evaluate by phone or in person
Evaluation/ Pre-Study Visit Expectations
Meet & Greet

11. 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).

12. Initiation Visit Purpose
Provide Protocol and Investigational Product/Device Training
Outline expectations of Investigator and research personnel
Confirm study supplies received
Initiation Visit Purpose
Why Initiations are so critical for the Sponsor and the Site to engage in open dialogue.

13. Initiation Visit Purpose
Collect remaining essential documents
Occurs prior to enrollment commencing
Attendance expected of Investigator and Key Research Personnel
Initiation Visit Purpose
Why Initiations are so critical for the Sponsor and the Site to engage in open dialogue.

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. Close-Out Visit Purpose
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

23. 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

24. Are You Ready?