Designing Paper-Based Case Report Form

Why should you take this eConference?
We may live in an electronic age, but paper-based case report forms (CRFs) still lie at the heart of most device trials. Case report forms that don't capture the right content in a form-filler, friendly format can bring an otherwise well-designed trial to its knees.

What you will learn about content:
1. What are the different kinds of data.
2. What are the different kinds of claims.
3. How (proposed) claims dictate the endpoints, which dictate the protocol and medical risk analysis.
4. That the CRF content must follow exactly and exclusively from the protocol and medical risk analysis.
5. What it means to substantiate a claim.

What you will learn about format:
1. Why you should invest in a decent design application.
2. What are the five basic response formats and when do you use them?
3. What does it mean to "code" responses, and why bother?
4. Layout considerations: how big to make the boxes, etc.
5. An FDA accepted format for safety check and adverse event forms.

Objective:
To learn the critical role of case report forms in the cycle of clinical trial data: (proposed) claims > hypotheses > endpoints > protocol > case report forms > database application > data analysis > (substantiated) claims.

You will receive:
1. A demonstration using Microsoft Visio.
2. A set of case report forms from an FDA approved IDE.
3. PowerPoint slides from Dr. Stark's presentation.
4. Certificate of attendance and 0.15 CEUs.

Presenter:
The eConference will be presented by Dr. Nancy J Stark. Dr. Stark was selected as one of 100 notable people in the medical device industry by Canon Communications in 2004. You can learn more about her at http://www.nancystark.com.

The purchase is $400 for the CD. Event materials are available on the CD itself. 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.