The Clinical Data Management Process - SDC Clinical

ARVO Annual Meeting, May 2012

Poster

Approval of new retina drugs by the US Food and Drug Administration (FDA) is contingent upon trust and belief that clinical trial data are of sufficient integrity. From database build to database lock, clinical data management (CDM), the process of collecting, cleaning, and managing subject and/or trial data in compliance with regulatory standards, is a crucial component of any clinical trial.

This publication details:

• The clinical data management CDM process in its entirety
• The roles of various CDM team members
• Tips for efficient data management practices
• The importance of CDM as part of the overall clinical trial team

Authored by:

• Aron Shapiro
• Dale Usner, PhD