CDISC Leads Industry To Define Standards

Recently, at the annual DIA meeting, FDA deputy commissioner for operations and chief operating officer, Janet Woodcock announced that, CDISC (Clinical Data Interchange Standards Consortium) will lead a collaborative group of industry stakeholders to focus on the Critical Path Opportunity to enable standardized collection of clinical research data at investigative sites.

Dr. Woodcock said, “The industry needs consensus on the definition of high quality data and that standardization is the best tool for ensuring quality. CDISC has done excellent work so far on the data standards we all use.” FDA/HHS have endorsed the CDISC standard for eSubmission data—SDTM (Study Data Tabulation Model), and listed it as a specification in FDA Guidance. Based on CDISC’s role enabling consensus around clinical data standards, CDISC leadership will now be used to bring together a collaborative group to develop standards for data collection.

Earlier this year, CDISC was asked to assume this leadership role from the Association of Clinical Research Organizations (ACRO), which initiated the project last year. ACRO has agreed to continue its involvement and currently there are ten organizations involved with the collaborative group, including: American Medical Informatics Association (AMIA), National Clinical Research Resources (NCRR), National Institutes of Health (NIH), and Pharmaceutical Research Manufacturers Association (PhRMA). CDISC is currently seeking funding for this project.

“CDISC will bring its standards-development process and global approach to this initiative,” said CDISC board chairperson and SAIC vice president, Dr. David Hardison. “We feel this is a critical aspect of the overall CDISC mission to facilitate protocol-based biomedical research, from the protocol authoring and generation of data collection tools through results reporting, making the process easier for investigative sites and all stakeholders.”