This page provides access to the official ICH-controlled terminologies developed to support ICH technical specifications and guidelines. CDISC is responsible for the curation, governance, and public review of these terminologies, ensuring they are:
- Developed through a transparent and inclusive process
- Freely available to the public
- Maintained in alignment with CDISC's rigorous terminology standards
ICH retains ownership of its specific terminologies, while CDISC ensures their ongoing publication and accessibility through this platform. This agreement supports global adoption of standardized, interoperable clinical research practices.
Browse the ICH Terminology Resources below or learn more about the CDISC-ICH agreement:
| ICH Guideline | Guidelines(s) Link | Terminology Download Link | Terminology OID Link |
|---|---|---|---|
| ICH M11 | The ICH M11 Template, Technical Specification, and companion document(s) are available here: https://ich.org/page/multidisciplinary-guidelines#11 | https://evs.nci.nih.gov/ftp1/ICH/M11/ | https://www.ich.org/page/electronic-standards-estri |
The Clinical Data Interchange Standards Consortium (CDISC) and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) have formalized a strategic partnership through a Memorandum of Understanding (MOU). This collaboration is designed to formalize a collaborative framework for the development, governance, maintenance, and public accessibility of controlled terminologies that support global clinical research and regulatory harmonization.
ICH is a global organization that brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical development with a goal of developing international guidelines and technical specifications.
ICH focuses on the development of guidance in the areas of safety, quality, and efficacy associated with the development, registration, and maintenance of human pharmaceutical products. Such guidance is published by ICH via the ICH website (www.ich.org) and by individual regulatory authorities within the ICH regions and beyond.
The agreement between CDISC and ICH supports the development, curation, governance, and maintenance of ICH controlled terminologies that are critical for the implementation of ICH technical specifications and guidelines. These terminologies are standardized, interoperable, and made publicly available through the NCI Thesaurus using CDISC’s established governance processes.
- Ensure Unified Governance: Create a consistent, transparent, and rigorous process for the creation and maintenance of ICH-controlled terminologies using CDISC’s terminology governance framework.
- Enable Public Accessibility: Ensure that all ICH-controlled terminologies are freely available to the public following review and publication through CDISC.
- Provide Transparency and Quality: Support a clear, well-documented public review process that encourages community feedback and ensures technical and scientific accuracy.
- Enable Long-Term Maintenance: Provide a sustainable mechanism for ongoing updates and stewardship of terminologies, ensuring their continued relevance and consistency with evolving global regulatory and research needs.
- Support ICH Projects (e.g., M11 CeSHarP): Apply the governance process specifically to projects like the ICH M11 Protocol Template, which requires harmonized and governed terminology for global implementation.
- ICH: Owns the controlled terminologies used in ICH guidelines, defines new terms and approves updates.
- CDISC: Facilitates governances processes, inclusive of public review, comment reconciliation, publication, and ongoing maintenance of terminologies.
- Joint Activities: Both organizations co-own and co-publish jointly developed metadata or standards ensuring consistency and shared stewardship.
The MOU aligns ICH’s regulatory leadership with CDISC’s data standards expertise to establish a transparent, sustainable, and unified approach to managing the language and terminology that underpin global pharmaceutical regulation and research.