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# ICH Clinical Practice Guide Annex
- URL: https://www.fdaweb.com/ich-clinical-practice-guide-annex/
- Published: 2025-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:49:30.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5158399

FDA has published the International Council for Harmonization’s draft Good Clinical Practice (GCP) E6(R3) guidance Annex 2\. The document [says](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-annex-2?ref=fdaweb.com) Annex 2 provides additional GCP considerations, focusing on examples of trials that incorporate decentralized elements, pragmatic elements, and/or real-world data.

“Annex 2 is not meant to be comprehensive of all design elements since clinical trial ecosystems may continue to evolve, and the operational approaches and data sources utilized may expand,” the annex says. “However, considerations provided in this annex may apply in accordance with local regulatory requirements. This annex should not be read as an endorsement of any specific trial design elements or data sources and should be read in collaboration with the principles and Annex 1.”