ICH harmonised guideline integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2)
INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)
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
Source: European Medicines Agency, 2018
Clinical Research News
Aankomende klinische onderzoeken
-
Magnus MedicalCongressionally Directed Medical Research ProgramsWerving
-
Nicholas ButowskiSiren BiotechnologyNog niet aan het wervenGlioom | Hersenen neoplasma | Terugkerende hooggradige gliomenVerenigde Staten
-
State University of New York at BuffaloNog niet aan het wervenBetrokkenheid van de patiëntVerenigde Staten
-
Poitiers University HospitalNog niet aan het werven
-
Assistance Publique - Hôpitaux de ParisNog niet aan het wervenSikkelcelziekte | Vaso-occlusieve crisis
-
University of California, IrvineWervingHersenkanker | Kanker van het CZS | Kanker van het zenuwstelsel | Hersenkanker UitgezaaidVerenigde Staten
-
Qualia Life SciencesWerving
-
Guangdong Raynovent Biotech Co., LtdNog niet aan het wervenFundamentele wetenschap
-
The Hong Kong Polytechnic UniversityWu Jieh Yee Charitable FoundationWervingVolwassenen | Digitale assistentie voor slechtzienden | Visuele beperkingenHongkong
-
Shanghai General Hospital, Shanghai Jiao Tong University...Nog niet aan het wervenDuctaal adenocarcinoom van de alvleesklier (PDAC)
-
Sun Yat-sen UniversityNog niet aan het wervenStoppen met roken | AI-agent | Early-Stage Cancer
-
Affiliated Hospital of Nantong UniversityNog niet aan het werven
Clinical Research Jobs
-
Poland - Warsaw
-
Spain - BarcelonaSpain - Sant Feliu De Llobregat
-
Australia
-
Romania - Bucharest
-
Philippines - Manila
-
India - Bengaluru
-
United States - North Carolina - Morrisville
-
China
