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
-
Peking University Third HospitalPeking University; The First Affiliated Hospital of Anhui Medical University og andre samarbejdspartnereRekrutteringPræeklampsi | Høj risiko graviditet | Tvillinggraviditet, førfødselstilstand eller komplikation | Forudgående | Twin Dichorion Diamniotic Placenta | Tvilling til tvilling transfusion som førfødselstilstand | Tvilling placenta | Twin monokorionisk diamniotisk placentaKina
-
Theodor Bilharz Research InstituteRekruttering
-
Sormland County Council, SwedenEskilstuna municipalityIkke rekrutterer endnuDepression | Depressive symptomer
-
Shandong Suncadia Medicine Co., Ltd.Ikke rekrutterer endnuType 2 diabetisk nyresygdom
-
University of California, San FranciscoIkke rekrutterer endnuSeksuelt overførte sygdomme, bakterielForenede Stater
-
Royal Marsden NHS Foundation TrustIkke rekrutterer endnu
-
Zhejiang UniversityNewislet Biotechnology (Shanghai) Ltd.Rekruttering
-
Natera, Inc.Ikke rekrutterer endnuHjertetransplantationssvigt og afvisning
-
University Hospital, Clermont-FerrandUniversité d'Auvergne; Effik; AUDIPOGIkke rekrutterer endnu
-
M.D. Anderson Cancer CenterIkke rekrutterer endnuSpiserørskræftForenede Stater
-
Seoul National University HospitalMedtronicRekrutteringType 1 diabetesKorea, Republikken