Schedule: February 10, 2010.
11 AM Central Time. 

Fee: $500 first learner
$195 per additional learner
$75 for late quiz

Agenda:
Lecture - 5 hours
Quiz- .5 hour

CEUs:
0.55 (IACET/ISO guidelines)

Good Monitoring Practices Workshop
Sponsors were first given responsibility to monitor the progress of their clinical trials by the regulations of 1974-76. It was a revolutionary concept, having its roots in the civil rights movement of the sixties. And it not well-received by investigators who could sense the coming accountability to outside entities.

Monitoring, then, plays a unique role in the relationship of sponsor and investigator, demanding a technical knowledge of device and disease combined with the persuasion skills of good politician.  

That said, it isn't magic. Monitoring is a set of skills that can be mastered by anyone with a sense of order and completeness. If you like things to be 'finished' you will make a good monitor. 

 

Agenda:
Presentation—4 hours
Quiz—1 hour
Course Assessment—10 minutes

Description and Learning Objectives:
There are four types of monitoring visits: prestudy, initiation, routine, and close-out. Each type of visit has its own objectives and criteria. The prestudy visit is a job interview to assess the candidate investigator's experience, training, site suitability, and subject availability. Initiation visits are really initiation processes whereby investigators receive specialized training in device use as well as other requirements of the study. Routine visits are the workhorse of monitoring, where the monitor follows and reports on trial progress. Close-out visits are for bringing the site to inspection-readiness; they’re like filing your tax returns, simple if you’ve kept good records and complex if you haven’t. The types of monitoring visits have their roots in the FDA guidance "Monitoring of Clinical Investigations".

In this workshop you’ll receive a model set of standard operating procedures for each of the four types of monitoring visits. You'll learn the requirements and typical problems for each one and look at case studies to discuss how to handle them. Approaching the learning task using many different tools, the course uses lecture, slides, colorful flowcharts, decision-making polls, and a challenging quiz to help you master this well-researched material.

Learning Objective:
The learning objective is to be able to identify and implement the four types of monitoring visits in a clinical trial.

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) Standard operating procedures for monitoring visits.
4) Checklists and report templates for monitoring visits.
5) Online exam with immediate score results.
6) Certificate of Attendance and 0.5 CEUs.

Who should attend:
[x] Monitors.
[x] Clinical research professionals.
[x] Managers designing monitoring plans for IDEs.
[x] Executives for start-up companies.