ICH E6 (R3) Guideline on good clinical practice (GCP)
International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use
GOOD CLINICAL PRACTICE (GCP) E6(R3) Step 5
23 January 2025. Date for coming into effect 23 July 2025
ICH E6(R3) introduces innovative provisions designed to apply across various types and settings of clinical trials, ensuring continued relevance in the face of ongoing technological and methodological advancements. This guideline provides a new language to facilitate innovations in clinical trial design, technology, and operational approaches. It encourages a risk-based and proportionate approach to conducting clinical trials, promoting fit-for-purpose solutions. It fosters transparency through clinical trial registration and result reporting and offers additional guidance to enhance the informed consent process.
The overarching principles and Annex 1, adopted by ICH and CHMP, came into effect on 23 July 2025.
With the public consultation now concluded, the Annex 2 is expected to be finalised later in 2025.
I. INTRODUCTION
II. PRINCIPLES OF ICH GCP
III. ANNEX 1
1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
2. INVESTIGATOR
3. SPONSOR
4. DATA GOVERNANCE – INVESTIGATOR AND SPONSOR
Appendix A. INVESTIGATOR’S BROCHURE
Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL
GLOSSARY
© European Medicines Agency, 2025. Reproduction is authorised provided the source is acknowledged.
Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us
Send a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000
Clinical Research News
다가오는 임상 시험
-
Wake Forest University Health Sciences아직 모집하지 않음
-
West China Second University Hospital아직 모집하지 않음잠 | 위 선암종 | 위식도 접합부 선암종 | 병리학적 반응
-
M.D. Anderson Cancer Center모병줄기세포 이식 | 젬시타빈 | 도세탁셀 | 카보플라틴 | 소아 재발 | 전향적 관찰 연구 | Melphalan | Refractory Germ미국
-
Washington University School of MedicineCompass Therapeutics아직 모집하지 않음
-
AstraZeneca아직 모집하지 않음제2형 당뇨병미국, 스페인, 덴마크, 헝가리, 중국, 대만, 남아프리카, 그리스, 아르헨티나, 일본, 대한민국, 터키 (Türkiye)
-
Arcus Biosciences, Inc.아직 모집하지 않음
-
West China Second University Hospital아직 모집하지 않음위 선암종 | 정신적 고통 | 위식도 접합부 선암종 | 병리학적 반응
-
West Virginia University아직 모집하지 않음
-
Arrowhead Pharmaceuticals아직 모집하지 않음
-
AstraZeneca아직 모집하지 않음제2형 당뇨병미국, 덴마크, 영국, 헝가리, 브라질, 베트남, 말레이시아, 대만, 중국, 독일, 그리스, 폴란드, 우크라이나, 체코, 일본, 푸에르토 리코, 아르헨티나, 대한민국
-
Boehringer Ingelheim아직 모집하지 않음비만 | 초과 중량미국, 호주, 영국, 캐나다, 중국, 뉴질랜드, 대한민국
Clinical Research Jobs
-
Japan - Tokyo
-
United Kingdom - London
-
France - Evreux
-
Bulgaria - Sofia
-
Poland - Krakow
-
India - Bengaluru
-
United States - North Carolina - Morrisville
-
China
