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
Kommende kliniske forsøg
-
Baptist Health South FloridaBaptist Health FoundationIkke rekrutterer endnuMavekræft | BækkenkræftForenede Stater
-
Chonnam National University HospitalRekrutteringKoronararteriesygdom | KoronararteriestenoseKorea, Republikken
-
University of AlcalaIkke rekrutterer endnu
-
The First Hospital of Jilin UniversityRekruttering
-
National Cancer Institute (NCI)Ikke rekrutterer endnuGliom | Astrocytom | Tilbagevendende glioblastomForenede Stater
-
National Heart, Lung, and Blood Institute (NHLBI)Ikke rekrutterer endnu
-
National Institute on Alcohol Abuse and Alcoholism...Ikke rekrutterer endnuAlkoholbrugsforstyrrelseForenede Stater
-
National Cancer Institute (NCI)RekrutteringBrystkræft | Kolorektal cancer | Livmoderhalskræft | Ikke-småcellet lungekræft | Gastrointestinal kræft | Genitourinær kræft | Metastatiske faste kræftformerForenede Stater
-
National Institute of Arthritis and Musculoskeletal...Ikke rekrutterer endnuSystemisk lupus erythematosusForenede Stater
-
National Institute of Allergy and Infectious Diseases...Ikke rekrutterer endnuEksem | Atopisk dermatitisForenede Stater
-
National Center for Complementary and Integrative...Ikke rekrutterer endnu
-
AbbVieRekrutteringRheumatoid arthritisForenede Stater, Japan, Det Forenede Kongerige, Canada, Korea, Republikken, Puerto Rico, Sydafrika, Ungarn, Bulgarien, Spanien, Portugal, Chile, Kroatien, Frankrig, Belgien, Tyskland, Grækenland, Rumænien, Brasilien, Italien, Ser... og mere