Monday, September 17, 2007

Good Clinical Data Management Practices earns international recognition
by Kelly Winget, DCRI Communications

Clinical data management is a crucial part of the review and approval of new medications or medical devices. Part of providing the most accurate data is to ensure people are using consistent processes across data management.

The Society for Clinical Data Management (SCDM) was recently recognized as the most successful company/program of the year for raising good clinical practice (GCP) standards. The recognition was for their Good Clinical Data Management Practices document (GCDMP). The Annual GCP Journal Awards were presented September 12 in London.

The document, initiated from an FDA / SCDM collaboration, was created by Kaye Fendt, MS, who also authored the Electronic Data Capture section of the document.

Several DCRI/DTMI staff played key roles in creating and maintaining the document. Barbara Tardiff, MD, a Duke faculty member and former DCRI Data Management Director, authored the Data Processing section. Meredith Nahm, MS, associate director of Biomedical Informatics at the DTMI, wrote the Assuring Data Quality and Measuring Data Quality sections. Terri Pennell, MBA, previously a manager and auditor at the DCRI, is a member of the maintenance committee for the document. Mary Foy, Clinical Data Specialist III at the DCRI, currently serves on the SCDM Board of Trustees who reviews and approves updates to the document.

Pharmaceutical companies and regulatory agencies rely on data from clinical trials to make many of their decisions. But prior to the SCDM, there were no best practice guidelines specific to clinical data management.

"The GCDMP committee was formed to provide guidance to the industry by identifying and describing minimum standards and best practices for data management," said Nahm.

Recently, the committee established a plan to keep the GCDMP up-to-date as the industry continues to change. Not only does the document help implement high-quality data management processes, but it is also used by organizations as a tool to train and educate new clinical data management staff, and by individuals as a reference for the SCDM National Certification exam.