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
다가오는 임상 시험
-
Beijing Tiantan HospitalBeijing University of Chemical Technology; Beijing Healthunion Cardio-Cerebrovascular Disease...아직 모집하지 않음
-
Seattle Institute for Biomedical and Clinical ResearchPatient-Centered Outcomes Research Institute아직 모집하지 않음
-
Brigham and Women's HospitalIntegrum; Massachusetts Institute of Technology (MIT)아직 모집하지 않음
-
University of PittsburghNational Institute on Alcohol Abuse and Alcoholism (NIAAA)모병
-
Guangdong Provincial People's Hospital아직 모집하지 않음
-
The University of Texas Health Science Center,...Brighter Bites and Humana Foundation아직 모집하지 않음
-
Lebanese University모병
-
University of Wisconsin, Madison아직 모집하지 않음