Version 10 of the Glossary of ICH Terms and Definitions, compiled by CIOMS (Council for International Organizations of Medical Sciences), was published on 15 June 2026. The reference assembles approximately 1,479 definitions from 159 ICH guidelines in alphabetical order — the de facto common language of the clinical research world. And the headline of V10 is this: with E6(R3) Annex 2 (Step 4 final, 3 June 2026), the foundational terms of decentralised clinical trials are now in the official ICH glossary. This post summarises what changed in V10 and which terms to watch.
What exactly changed in V10?
The glossary's version note names three new sources:
Version Date ICH documents added V10 15 June 2026 E6(R3) Annex 2 (Step 4 final, 3 June 2026) · M15 General Principles for Model-Informed Drug Development (Step 4 final, 29 January 2026, 22 definitions) · Q14 (error-corrected version) V9 9 December 2025 E20 draft (adaptive designs), E22 draft (patient preference), E2D(R1), the M11 CeSHarP family, M14, Q3E draft V8 5 June 2025 E6(R3) main guideline (Step 4 final, 6 January 2025) and the Annex 2 draftIn other words, V10 mirrors 2026 — the year the E6(R3) modernisation completed: the new generation framework of good clinical practice (GCP) and its decentralised-elements annex have now met in the glossary in final form.
Headline: E6(R3) Annex 2 — the official vocabulary of decentralised elements
Annex 2 reaching Step 4 (final) means a binding language set for the entire ICH region, not just Europe. The core of the 11 definitions that entered the glossary is these three:
Decentralised elements: "For the purposes of Annex 2, decentralised elements in a clinical trial are those trial-related activities conducted outside the investigator's location. These may include trial visits and/or protocol-related procedures conducted at the trial participant's home, local healthcare centres or mobile medical units. They also encompass remote interactions, such as video calls or the use of digital health technologies (DHTs) to conduct visits, perform procedures and collect data."
Digital health technologies (DHTs): "...a broad term to reflect the wide range of technologies supporting healthcare used to collect, measure, or monitor health-related data from participants or patients (e.g., mobile applications, wearables, and sensors)..."
Pragmatic elements: "...those that integrate aspects of usual clinical practice into the design and conduct of the trial."
Annex 2 also brings an assessment framework for the entry of real-world data (RWD) into interventional trials: the fitness for purpose of RWD is defined through reliability and relevance, and the definition of source records now explicitly covers wearable/sensor data and relevant metadata.
The Türkiye context: translated into field practice, these definitions look familiar — home visits, mobile medical units, remote monitoring and digital data collection are tools TİTCK legislation already recognises. For models in Türkiye that reduce trial burden through home-based visits, see our patient-centred solutions page; for the established regulatory framework of decentralised research, see our regulatory hub.
Other definitions to watch in the main glossary
Highlights from the term world of the E6(R3) main guideline (66 definitions) and the CeSHarP/M11 protocol template:
- Sponsor: the E6(R3) definition directly addresses the reality of multi-sponsor trials for the first time: "An individual, company, institution or organisation that takes responsibility for the initiation, management and arrangement of the financing of a clinical trial. A clinical trial may have one or several sponsors where permitted under regulatory requirements... Where the documented agreement does not specify to which sponsor a given responsibility is attributed, that responsibility lies with all sponsors." Abandoning the classic single-sponsor assumption directly affects how protocol contracts should be written.
- Informed consent: the E6(R3) definition describes the process with examples such as "providing text in different formats, images and videos and using telephone or video conferencing with investigator site staff", and the phrase "obtaining consent remotely may be considered when appropriate". It is consistent with the informed consent form (ICF) practice under Turkish legislation — but the door to electronic and remote consent is explicitly opened.
- Monitoring: "The act of overseeing the progress of a clinical trial and of ensuring that the clinical trial is conducted, recorded and reported in accordance with the protocol, SOPs, GCP and the applicable regulatory requirement(s)" — and in E6(R3), the monitoring report explicitly follows "site and/or centralised monitoring activities". Risk-based and centralised monitoring strategies are now embedded at the vocabulary level.
- SUSAR: "An adverse reaction that meets three criteria: suspected, unexpected and serious" — with each of the three criteria defined individually. The structure matches the Turkish regulation one-to-one; it is the common language of safety reporting processes.
- Investigational product: "A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial..." — the ICH-language counterpart of the IMP (investigational medicinal product) concept in Turkish legislation.
- Trial oversight and data governance (M11 CeSHarP): trial oversight describes the planned processes to govern and conduct a clinical trial in order to protect the rights, safety and welfare of trial participants; data governance covers the key processes ensuring data integrity, traceability and security. The new vocabulary for everyone writing Section 11 of a protocol.
M15 and model-informed development
The second major addition in V10 is the 22 definitions from M15, finalised in January 2026: the vocabulary of model-informed drug development (MIDD) evidence, model outcomes and validation. The growing place of modelling in clinical development plans means statistics and clinical pharmacology teams will build their common language on these terms. The next version's agenda holds the final forms of the E20 (adaptive design) and E22 (patient preference) drafts.
What is still absent from the glossary is also informative
An interesting negative finding: the term "diversity" still does not appear in V10. While diversity action plans grow on the clinical research agenda, the fact that the ICH glossary has not yet defined the concept suggests it is one of the most likely additions in coming versions. Worth tracking.
Reflections for Türkiye and practical recommendations
This term world produces three practical consequences for teams in Türkiye preparing protocols, GCP compliance documents and templates: (1) get used to protocols written in E6(R3) Annex 2 terminology — the definition of decentralised elements now lives in one place; (2) align the contract language of multi-sponsor structures with the E6(R3) Sponsor definition; (3) in designs involving electronic/remote consent, centralised monitoring and DHT data, write the new scope of the source records definition into data management plans.
For Türkiye's ICH E6(R3) process and its legislative counterparts, use our regulatory hub; for the full text of the published Good Clinical Practice guideline, our legislation library; and for the established Turkish equivalents of regulatory terminology, our regulatory glossary.
Frequently asked questions
What is the CIOMS/ICH glossary and who is it for? A reference document in which CIOMS compiles the terms and definitions of ICH guidelines into a single PDF (V10: ~1,479 definitions from 159 guidelines). It provides a common language for anyone writing protocols, contracts and training materials.
What is the most important innovation in V10? E6(R3) Annex 2 (the decentralised elements annex) reaching Step 4 final on 3 June 2026 and bringing 11 new definitions to the glossary: decentralised elements, DHTs, pragmatic elements and the fitness-for-purpose terms for RWD.
Can I use the definitions in my own documents? The definitions are quoted from ICH guidelines; the sound approach is to use them with attribution (guideline name + CIOMS glossary V10, DOI: 10.56759/eftb6868) and in excerpt — the glossary carries no explicit reuse licence.
Where can the glossary be accessed? It is published free of charge by CIOMS under a DOI (doi.org/10.56759/eftb6868); the full texts of the source ICH guidelines are open to everyone at database.ich.org.
Source: CIOMS, Glossary of ICH Terms and Definitions, Version 10 (15 June 2026), DOI: 10.56759/eftb6868; ICH E6(R3) and E6(R3) Annex 2 (Step 4, 3 June 2026), database.ich.org. Quoted definitions are taken from the ICH guideline texts.