Risk-Based Monitoring for Device Trials

A CD Course by Dr. Nancy J Stark
22 November 2011

In August 2011, FDA withdrew the 1988 "Guideline for Monitoring of Clinical Investigations", and in doing so withdrew the very concept of pre-study, study initiation, routine study, and study close-out activities. Instead of monitoring at these highly recognized milestones, FDA now encourages linking on-site monitoring visits to critical data and processes that have gone "high-risk" as identified by a centralized electronic data capture system. This fundamental shift in how we look at study management is described in a new draft guidance for industry, "Oversight of Clinical Investigations—Risk-Based Approach to Monitoring" (Aug 2011).

The guidance flies in the face of the new international standard ISO 14155 "Clinical investigations of medical devices in human subjects—good clinical practices" (2011) and is only marginally consistent with ICH-GCPs. Why is FDA encouraging such a radical shift in our approach to study management? Will we, once again, have to rewrite our quality management systems for clinical investigations? Is there a career future for monitors? And most importantly, how can device firms leverage the new guidance to reduce monitoring costs?

Objectives
The course objectives are:   
[1] To learn the content of FDA's draft guidance "Oversight of Clinical Investigations—Risk-Based Approach to Monitoring" (August 2011).
[2] To learn when on-site, off-site, and centralized monitoring are appropriate.
[3] To understand a world that does not think in terms of pre-study, study initiation, routine study, and study close-out visits.
[4] To gain ideas about how to take advantge of the new guidance in a device-centric industry.

Centralized Monitoring
FDA discusses only two methods for monitoring clinical trials, the on-site visit and centralized monitoring. Historically, on-site visits have been indexed to the timing of the study: pre-study, study initiation, routine study, and study close-out visits. But now, since those concepts no longer exist in FDA's mind, monitoring visits are tied to the occurrance of high-risk events or processes.

Electronic data capture systems are key to centralized monitoring. Data are sent to a central data management center from sites around the world. Algorithms programmed into the database detect when a critical data element or critical study process has gone "high-risk", thus triggering additional monitoring, including a possible on-site monitoring visit. In the scary future, a subject's entire source file might be transmitted to the central server and case report forms source verified electronically, possibly triggering on-site monitoring because source data and study data are inconsistent.

The course discusses the concepts of centralized monitoring, the challenges of integrating it into your existing study management, and how device sponsors have been doing variations on monitoring methods for years.

Courses on CD
The two-hour course is available as a prerecorded CD. CD Courses are a great information bargain. You can stop and start the presentation as often as you like, share the CD with your colleagues, watch it at different times, and build a library of material for training new employees. Certificates and CEUs (0.25 units) are available. Just watch the entire presentation (on your honor) and return the completed Word survey. Your certificate will be emailed to you.

You Will Learn
Specifically, you will learn the contents of the new guidance and how it will affect your study management, such as:
[1] Identifying critical data elements and study processes.
[2] Calculating Risk Priority Numbers.
[3] Assemblying a risk assessment of study data and processes.
[4] The parts of a Monitoring Plan,
    [a] Description of monitoring approaches to be used in the study.
    [b] Communication of monitoring results.
    [c] Management of investigator non-compliance.
    [d] Training for monitors and sites.
    [e] Process for amending the Monitoring Plan.

You Will Receive
[1] A CD with slides, handouts, feedback survey, and Flash playable presentation.
[2] PowerPoint slides as pdfs.
[3] Handouts describing triggers and risk assessment.
[4] Template for a Monitoring Plan.
[5] A renowned speaker, Dr. Nancy J Stark.
[6] Opportunity to give course feedback.
[7] 0.25 CEUs and Certificate of Attendance.

Course Level
This is an intermediate level course. Participants are assumed to have a basic knowledge of clinical research and device regulations.

How to Buy
Navigate to http://www.clinicaldevice.com/mall/eConferenceCD.aspx  and buy online or telephone 1-773-489-5706 to purchase a copy.

 

Nancy J Stark, PhD
President
Clinical Device Group Inc
[email protected]