CDG e Conferences & Workshops

Device AEs Exceed Drug AEs in 2008

Are You Over-Reporting?
Take the OnDemand Adverse Events Workshop to Find Out

The Government Accounting Office issued a report on Monday, 20 July 09, stating that the number of adverse events reported to FDA for medical devices outnumbered the number of adverse events for drugs for the first time in 2008. The number increased to 588,161 from 189,450 since 2004.

So many adverse event reports go to FDA that their tracking system is overwhelmed; they cannot track which individual reports have been reviewed and which have not. Ask us for a free copy of the GAO Report.

The incredible increase in medical device reports speaks loudly to the increase in medical device use, the increase in device complexity, and the increase in device importance in our healthcare system.

Top Twelve Mistakes Monitors Manage

The problems other people cause us...
Many of the problems you'll encounter at a site are the result of other people's actions. But too bad, you have to deal with them anyway. Here's the Top Ten Pick by clinical trial expert Lynette Chiapperino.

1. Trial designer writes impossible protocols.
2. Time, cost, quality--pick any two.
3. Last site visit not reviewed.
4. No action item list.
5. Site isolation.
6. Data points and endpoints don't match.
7. Those boring repetitive entries.
8. Unhappy trends, clues, issues.
9. Undocumented trends, clues, issues.
10. Unkept promises.

Here's another two picks by IVD clinical trial expert Gail Radcliffe.
11. Test results come late from the lab.
12. Out-of-date ranges and test methods not identified.

Learning objective
To be forewarned about common study site problems so you can deal with them creatively.

We will cover
[x] Lynette's Top Ten Pick of study site problems.
[x]How to prevent them.
[x] How to fix, manage, or control them.
[x] Or how to live with them--the problems won't change, so you will have to.

Dig, Dig, Dig
The hallmark of a good monitor is excavation. Every site has problems. You must think to what's behind the obvious to get to a solution. An investigator resigned? What was the motivation? Enrollment is slow? What else is going on in your site's life? Try to look beyond the immediate issue and then try various solutions to see what works.

You will receive
[x] PowerPoint Slides.
[x] Case studies and real examples.
[x] Ideas to try.
[x] An expert speaker.
[x] Certificate & CEUs.

Audience suitability
[x] People who monitor clinical trials.
[x] People who design clinical trials.
[x] People who implement clinical trials.
[x] People who manage clinical trials.
[x] People who work with clinical trial data.

Presenter
The e-conference will be presented by Dr. Nancy J Stark.

The purchase is $425 for OnDemand access and $475 for the CD. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.