Events

CDASH Webinar Series

Overview

The CDASH initiative is in follow-up to Critical Path Opportunity (#45) that seeks to enable standardized collection of clinical research data at investigative sites. Through standardization of basic data collection elements, efficiencies can be achieved that will result in less confusion across sponsors, investigators and research sites and facilitating more efficient monitoring, audit, submission and review procedures.

Many SCDM members have already heard about the CDASH project over the last year and a half. SCDM is not only a founding member of the CDASH Collaborative Group but many of our members have served as team leaders and participants on CDASH sub-groups.

This series of CDASH webinars will provide listeners with the opportunity to hear the background, objectives, project organization and process and well as a survey of the 16 domains developed by the CDASH project team. These 16 domains will be divided between the 2 webinars in order to allow for a more in depth survey.

Webinar #1 will focus on the basic data collection fields for CDASH Packages -1 and -2 (Adverse Events, Concomitant Medication, Demographics and Subject Characteristics, Inclusion/Exclusion Criteria, Medical History, Substance Use, Physical Exam and Vital Signs).

Webinar #2 will focus on the basic data collection fields for CDASH packages -3 and -4 (Drug Accountability, Exposure, Comments, Protocol Deviations, Disposition, Lab and ECG) and will introduce the CDASH consolidated draft document.

Both webinars will conclude with a presentation on the practical implementation of CDASH recommendations.

Presenters

Rhonda Facile, Project Director, CDASH Initiative
CDASH Core Team:
Dorothy Dorotheo, Director, Clinical Data Management, Intermune
Dave Iberson-Hurst, VP Technical Strategy
Shannon Labout, Senior Consultant for CSS Informatics
Mark Wheeldon, CEO of Formedix

Learning Outcomes

At the conclusion, participants should be able to:

Describe the benefits of CRF standardization for investigative sites and other stakeholders in clinical research.
Explain the CDISC Standards Development Process, and where the CDASH project is relative to this process.
Explain how CDASH collection fields can be used to create CRFs using ODM XML and how this will facilitate good CRF design and minimize collection of unnecessary data elements and ensure consistency across a clinical program.
Describe how CDASH data collection fields are related to other CDISC standards, specifically the SDTM and Terminology.
Describe how CDASH can facilitate interoperability between clinical systems, e.g. facilitating collection of data from EHRs or between 2 clinical data systems between a single or multiple CROs and Sponsors).

CDM Competencies addressed in the CDASH Webinar Series

EDC

Knows how to design electronic Case Report Forms to minimize data entry errors

Protocol Review

Challenges unnecessary data collection

CRF Design

Applies widely accepted good CRF design technique
Ensures CRF design consistency across a number of studies in a program

Target Audience

This webinar is for all levels of Data Managers plus clinical and statistical programmers; project managers; managers of data management groups; CRA�s; clinical development and investigators.

Continuing Education Units

SCDM will award continuing education units to participants who successfully complete each webinar. Assessment and post evaluation submissions are required. Upon completion of each webinar, please contact info@scdm.org for links to the assessments and evaluations. You will receive .15 CEU�s for successful completion of each assessment. (1 contact hour = .1 CEU)