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
-
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
Aankomende klinische onderzoeken
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Nog niet aan het wervenGeavanceerde niet-kleincellige longkanker
-
Roswell Park Cancer InstituteNog niet aan het wervenAnatomische fase III borstkanker AJCC v8 | Anatomische stadium IV borstkanker AJCC v8 | Gemetastaseerd triple-negatief borstcarcinoom | Lokaal gevorderd, niet-reseceerbaar drievoudig-negatief borstcarcinoomVerenigde Staten
-
Istanbul Medipol University HospitalWerving
-
ID3 MedicalAbbott; Vascular Science LP GmbHNog niet aan het werven
-
HealthPartners InstituteUnited States Department of Defense; Uniformed Services University of the Health...Nog niet aan het werven
-
Postgraduate Institute of Dental Sciences RohtakNog niet aan het wervenParodontitis | Parodontale aandoeningen | Bruxisme | Nood, emotioneelIndië
-
Cerevel Therapeutics, LLCNog niet aan het werven
-
Achieve Life SciencesNog niet aan het wervenStoppen met roken | Stoppen met vapenVerenigde Staten
-
GlaxoSmithKlineNog niet aan het werven
-
CellinCellsNog niet aan het werven
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Werving
-
Peking University Third HospitalBayerNog niet aan het werven