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
-
29 September 2023 – 02 October 2024SCDM (Society of Clinical Data Management)United States
-
10 – 11 April 2024The Society for Clinical Research Sites (SCRS)United States
-
16 – 18 April 2024InformaUnited States
-
17 – 19 April 2024SCDM (Society of Clinical Data Management)Poland
-
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
-
Universidad Complutense de MadridOsteology Foundation모병
-
Rhode Island HospitalBrown University아직 모집하지 않음
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Institutes of Health (NIH)아직 모집하지 않음
-
McGill University Health Centre/Research Institute...아직 모집하지 않음건강한 과목 | 1형 당뇨병(T1D)
-
UCB Biopharma SRL아직 모집하지 않음유년기 결석 간질 | 청소년 부재 간질
-
North Jersey AIDS Alliance dba North Jersey Community...City University of New York, School of Public Health아직 모집하지 않음HIV 감염 | 과다 복용 | HCV