Clinical Trials Training—eConferences and Courses on CD... |
There are many advantages of CD training: you can watch the presentation on your own schedule, stop and start it if you are interrupted, listen individually or in a group (have a pizza party), and build a library of resources for new hires. eConferences are recordings of advanced level topics with an expert guest speaker. They were recorded via webcast with a live audience, you will hear the questions and answers throughout the presentation. The typical format is a 60-minute presentation and about 30-minutes of Q&A. Courses are presentations of advanced level topics by Nancy J Stark. They are studio recorded, which gives better sound and video quality than webcasts. Dr. Stark poses discussion questions and thought experiments throughout the presentation to keep the presentation actively challenging. The typical format is a 60 to 90-minute presentation with an invitation to post your comments and questions on a blog-site linked to the presentation. All CDs come with pdf copies of the PowerPoint presentation, supporting handouts, and recorded presentations. We hope you enjoy the show. |
eConference and CD Course Descriptions
$400
Risk-Based Monitoring for Device Trials  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 This fundamental shift in how we look at study management is described in a new draft guidance for industry, "Oversight of Clinical Investigations—Risk-Based Approach to Monitoring" (Aug 2011).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 and cardinal 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? This two-hour pre-recorded presentation walks you through the new guidance document and discusses these and many more disruptive questions. Designed and recorded by Dr. Nancy J Stark on November 22, 2011. Click here for details. |
$400
The Critical Role of Risk Management in Clinical Trials  |
$400
Investigator Responsibilities: Compare & Contrast-FDA & ISO  Investigators are expected to make certain contributions to clinical investigations. But there are also many duties they typically take on that are not identified in any regulation or guidance. Some are standard practice, others are bad ideas. In this session you will learn the subtleties of investigator responsibilities, learn how sponsors can help assure investigator compliance, and see how the States compare with international expectations. The first half of the presentation will be a discussion of the FDA guidance document given by a bona fide medical device investigator. The second half will be a comparison to the ISO/DIS 14155 standard, given by Clinical Device Group. Presented on June 8, 2010 by Dr. John Pandolfino and Dr. Nancy J. Stark. Click here for more details. |
