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

Tips to a Successful Monitoring VisitNgoc Tran, CCRANT Research, Inc.

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.

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

Different but SameChanging mindsets

All for One and One for All

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

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.

Obtain Signed Confidentiality Agreement

Provide protocol synopsis for review

Evaluate by phone or in person

Evaluation/Pre-Study VisitExpectationsMeet & Greet

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).

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.

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.

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

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

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

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

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

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

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

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

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

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

Are You Ready?