View source for Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.1.4

{{ReferenceData
|has_document=Document:ICH ICH E6 Guideline R3 (2025)
|module=4
|unit=4.2.2
|scope=G
|doc_part=III. Annex 1
3.1.4
|language=EN
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00017-Spo-die ++ TAG-00033-Pro-oto ++ TAG-00128-Dat-rkz ++ TAG-00076-Fea-ung
|tags_display=[[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00128-Dat-rkz|Data capture tool]], [[Glossary:TAG-00076-Fea-ung|Feasibility]]
|comment=Operational feasibility and avoiding unnecessary complexity
|content=The sponsor should ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures and data collection. Protocols, data acquisition tools and other operational documents should be fit for purpose, clear, concise and consistent. The sponsor should not place unnecessary burden on participants and investigators.
}}