Monday, September 20, 2004

The DCRI and SCDM: Setting Standards for Data Managers
By Pat French

Five DCRI employees have earned the brand-new designation, Certified Clinical Data Manager (CCDM), by passing the inaugural certification examination offered by the Society for Clinical Data Management (SCDM).

Arleen Eppinger, Debra Fasteson-Harris, Brian McCourt, Meredith Nahm, and Reneé Pridgen of the DCRI's Clinical Data Integration (CDI) group were among the 36 people who passed the certification exam.

Meredith Nahm, MS

The computerized exam is offered throughout North America at Thompson Prometric testing centers. The DCRI staffers helped the SCDM develop the test by sitting for a 6-hour beta version of the test between January and March of 2004. The test was analyzed, the cut score was established, and the results were unblinded and testees were notified in August of 2004. All those who passed are now authorized to use the CCDM professional designation.

“Achieving certification is a significant accomplishment, especially in a profession that is rapidly changing and becoming more technical every day,” said Nahm, director of CDI and a new designee herself. “The certification exam sets the standard for the complete clinical data management skill set, including CRF design, database design, SQL programming, lab data management, data transfer, data quality control, data cleaning, medical coding, vendor management and regulations applicable to data management in 28 core competencies. To pass the exam, candidates need to have expertise in each of these core competencies.

The final version of which will be offered later this year. The test will be open to all clinical data managers who meet the educational and professional experience requirements.

To maintain the CCDM credential, designates must apply for and pass the recertification exam every 3 years. This is done to ensure that professionals remain current on changes in the industry’s role, definitions, and practices.

Three DCRI staffers also served as subject matter experts for the exam, working with the SCDM to develop test questions for the beta and final versions: Anita Walden, Debra Harris, and Nahm. Since this exam was validated by Thompson Prometric, the subject matter experts did not see the final test items.

SCDM is the leading organization for clinical data management professionals, with more than 1300 members throughout the U.S. and Canada working in the pharmaceutical, biotechnology, imaging, medical device, and diagnostic products industries. The mission of this nonprofit organization is to promote excellence in clinical data quality. The DCRI is proud to assist in this effort. Congratulations to the new CCDMs!