20080107 SCDM RELEASES DATA MANAGEMENT PLAN CHAPTER FOR THE GCDMP

SCDM RELEASES DATA MANAGEMENT PLAN CHAPTER FOR THE GCDMP

The Society for Clinical Data Management released the newest addition to its Good Clinical Data Management Practices (GCDMP) document with the publication of the Data Management Plan chapter in December. Charlene Dark, co-chair of the GCDMP Committee, commented that "In our continued commitment to advancing the profession of clinical data management, SCDM's GCDMP committee is very excited about the publication of the Data Management Plan chapter. This chapter is the first set of documented best practices in developing a data management plan. We believe that we have compiled a sound guidance for data managers, and we have made great strides in the direction of more standardized practices when developing and maintaining a data management plan. We are very proud of this accomplishment."
The Data Management Plan chapter is available to members through the Society's website. Non-members are able to access the entire updated document for a fee. A podcast version of this newest chapter is in production and scheduled for release in the first quarter of 2009.
SCDM would like to recognize and thank all subject matter experts who contributed to the development of the Data Management Plan chapter, including: Michele Goldstein (University of Rochester), Laura Fazio (DePuy Orthopaedics, Inc.), Reza Rostami (DCRI), Denise Redkar-Brown (Cetero), Joseph Pascua (Genentech, Inc.), Pam Harvey (American College of Radiology) and Mary Baldovsky (PharmaNet). Further, the chapter benefited from extensive peer review by the entire GCDMP committee, SCDM's Board of Trustees and an international review from selected members of INCDMA. To learn more and to access the chapter, go to www.scdm.org.

Good Clinical Data Management Practices

Title
Executive Summary, Acknowledgements, and Introduction
Data Privacy
* Vendor Management
Data Acquisition
* EDC Study Startup
* EDC Study Conduct
* EDC Closeout
* CRF Completion Guidelines
CRF Printing and Vendor Selection
Database Validation, Programming, and Standards
Laboratory and Other External Data
* CDM Presentation at Investigator Meetings
Training
Metrics for Clinical Trials
Data Storage
Assuring Data Quality
Measuring Data Quality
Data Entry and Data Processing
Dictionary Management
Safety Data Management and Reporting
Serious Adverse Event Data Reconciliation
Database Closure
* Clinical Data Archiving
* Data Management Plan
Glossary