CDISC employs a rigorous approach to developing data standards. Each standard is informed and shaped by experts, making them not just of the highest quality, but also attuned to the practicalities of their implementation. CDISC standards development is an open, consensus-based process. Broad participation and collaboration with multidisciplinary reviews ensure quality and fitness for use as well as encourage the widest adoption of our standards.
CDISC Operating Procedure 001 outlines the principles, process and deliverables for the development of CDISC standards. During the Standards Development Process, each standard goes through the following statuses:
- Draft Status – The proposed standard is in development by CDISC teams.
- Provisional Status – The standard has completed the CDISC Standards Development Process and can be published for use, but some of the Foundational Standards’ components (e.g., Controlled Terminology, new variables, biomedical concepts, draft domains) within it may not be Final.
- Final Status – The standard has completed the CDISC Standards Development Process and has been published for use.
The Draft and Final definitions seem cut and dry. But what about Provisional?
We recommend you implement Provisional standards, keeping in mind that certain components within these standards might never be Final. Provisional status usually applies to Therapeutic Area User Guides , which are based on various models and implementation guides of Foundational Standards . When working with a Provisional release, it’s important to check subsequent releases of models and implementation guides as draft domains and/or new variables may have become final and published as part of a Foundational Standard. Additionally, Controlled Terminology is released quarterly; it’s essential to check these release packages as the definitive source for all CDISC Controlled Terminology.