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
Aankomende klinische onderzoeken
-
Northwestern UniversityJohns Hopkins University; University of Iowa; Indiana UniversityNog niet aan het wervenEpilepsie | Hersentumor Volwassene
-
Europainclinics z.ú.East Slovak Institute for Cardiovascular DiseasesWerving
-
Spark Biomedical, Inc.Battelle Memorial InstituteNog niet aan het wervenCognitieve prestaties | Acute stressreactieVerenigde Staten
-
Beni-Suef UniversityWervingBehandeling van vagniale cabdudasisEgypte
-
University of ExeterWervingSpirulina-suppletie bij herstel na inspanningVerenigd Koninkrijk
-
Dong-A ST Co., Ltd.Nog niet aan het werven
-
Northwestern UniversityUniversity of Michigan; Ohio State UniversityNog niet aan het werven
-
University Medical Centre LjubljanaUniversity of Ljubljana, Faculty of MedicineNog niet aan het wervenPolyneuropathieën
-
mAbxience Research S.L.Werving
-
Sunshine Guojian Pharmaceutical (Shanghai) Co.,...WervingLokaal gevorderde, recidiverende of gemetastaseerde maligniteitenChina
-
Firat UniversityWerving