ICH harmonised guideline integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2)
International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve participation of human subjects to ensure that the rights, safety and wellbeing of the trial subjects are protected. Ensure the credibility of clinical trial data.
TABLE OF CONTENTS
1. GLOSSARY
3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
4. INVESTIGATOR
5. SPONSOR
6. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
8. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL
© European Medicines Agency, 2018
Clinical Research News
Upcoming Clinical Research Training and Conferences
-
on demandACROSS Global Training AcademyOnline
-
29 September 2023 – 02 October 2024SCDM (Society of Clinical Data Management)United States
-
21 – 23 May 2024InformaBelgium
-
03 – 04 June 2024The Society for Clinical Research Sites (SCRS)United States
-
16 – 17 July 2024The Society for Clinical Research Sites (SCRS)Australia
-
27 September – 29 October 2024The Society for Clinical Research Sites (SCRS)United States
今後の臨床試験
-
Université du Québec a MontréalCiusss de L'Est de l'Île de Montréal; PhysioExtra; Energir募集適応障害 | うつ病不安障害 | 不安気分を伴う適応障害 | 抑うつ気分を伴う適応障害カナダ
-
Institute of Cancer Research, United KingdomCase45 Ltdまだ募集していません
-
Milton S. Hershey Medical CenterNational Institute on Aging (NIA)まだ募集していません
-
Fundació Sant Joan de DéuUniversity Ramon Llull; Spanish Society of Pediatric Gastroenterology, Hepatology and Nutrition と他の協力者募集
-
Ohio State University Comprehensive Cancer CenterNational Comprehensive Cancer Network募集
-
University Hospital, Clermont-Ferrandまだ募集していません
-
Diakonhjemmet HospitalVestre Viken Hospital Trust; Hormone Laboratory, Aker University Hospital, Oslo, Norwayまだ募集していません骨粗鬆症 | 炎症性リウマチ | 骨粗鬆症、ステロイド誘発性
-
Western Michigan University School of MedicineBronson Methodist Hospitalまだ募集していません背中の痛み | 慢性の痛み
-
Insel Gruppe AG, University Hospital BernaiEndsoscopicまだ募集していません