Deviations and Amendments Workshop

What, exactly, are study deviations? Deviations are incorrectly implementing the research activities as defined in the protocol, changing the configuration of the investigational device mid-study, or failing to comply with regulations.

Deviations, violations, and amendments have an interesting and intercalated relationship, but no clear reporting requirements. In this workshop we'll use the FDA guidelines for study amendments to build a framework for managing and reporting deviations.

Agenda:
Presentation—3 hours
Quiz—1 hour
Course Assessment—10 minutes

Description::
First we'll examine the definitions for deviations, violations, and amendments and then look to see who commits them. By looking closely at the FDA warning letters to IRBs, investigators, and sponsors we can see inside FDA's mind. You will see what their inspectors call deviations and how one mistake can lead to multiple citations for all parties involved.

Throughout the workshop you'll pretend you are an FDA inspector and consider actual case studies to decide what citations to give investigators. Finally, using Part 812.35 [IDE] Supplemental Applications, you'll see how these approval requirements for amendments can serve as a framework for reporting deviations.

Approaching the learning task using many different tools, we'll use lecture, slides, colorful flowcharts, decision-making polls, and a challenging quiz to master this well-researched material.

Learning Objective:
The objective is to be able to identify a deviation when it occurs and determine to whom and when it should be reported.

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

You will receive:
1) One computer connection for one learner.
2) Printable copy of PowerPoint slides.
3) A searchable pdf file of 2006 CDRH warning letters.
4) IRB guidances and an IRB SOP for deviations.
5) Online quiz with immediate score results.
6) Certificate of Attendance and 0.4 CEUs.

Who should attend:
[x] Clinical research professionals.
[x] Regulatory professionals.
[x] Managers and decision-makers.
[x] Executives for start-up companies.
[x] Investigators for medical device trials.
[x] DSMB and CEC members.
[x] IRBs who review medical device trials