In the near future, data submitted to the FDA in support of applications for drug approvals must be in CDISC format, as outlined in a draft binding guidance issued in February 2014. If data do not conform, the FDA may “refuse to file” a submission.
CDISC standards are vendor-neutral, platform-independent standards that support the acquisition, exchange, submission and archival of clinical research data and metadata. SDTM and ADaM are the most frequently used models.
Before implementing, consider the team’s size and diversity, available resources and current level of CDISC adoption.
1) Start planning now—about two years remain until CDISC standards are required.
2) Integrate CDISC into overall product development. The FDA will require INDs and IDEs to include data standards plans.
3) Implementation of CDISC will affect work streams, work flows and work processes—which will affect timelines, budgets and resources.
4) Workload will increase in the short term; therefore, more resources and coordination are necessary to meet project timelines.
5) Programmers and statisticians must develop expertise beyond SAS and other statistical packages, such as knowledge of SDTM, ADaM and ISO standards. Creating the documentation file—define. XML—so it works reliably requires knowledge of XML, XML Schema and XSL.
6) Implement a training program to address CDISC’s broad impact on activities within a clinical trial and how it will affect work flow among many functions.
Integrating CDISC will present both challenges and benefits. A case study by Gartner found implementing standards early can save sponsors up to 60% of non-subject participation time and cost.
CDISC standards have an impact throughout the lifecycle of a product. ADaM and SDTM introduce changes in processes that may require costly and time-consuming allocation of resources. If you’re in the drug development business, you’re in the data standards business, too.
Written by Guest Writer Jeff Abolafia, MA. Abolafia is the chief strategist, data standards for CRO Rho. In this role, he directs data standards teams and develops processes, software and documentation to ensure company compliance with applicable FDA regulations. He also is responsible for company-wide CDISC planning and implementation. Abolafia joined Rho in 2003. www.rhoworld.com
This article was reprinted from Volume 22, Issue 02, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>
