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
Clinical Research News
- Jan 16
- Jan 11
- Jan 10
- Dec 16
- Dec 13
- Dec 06
- Dec 06
- Dec 05
- Dec 05
- Nov 23
Aankomende klinische onderzoeken
-
NCT05052216WervingObstructieve slaapapneu bij kinderen
-
NCT05710536WervingGezond Vagina Laxity
-
NCT05709327Nog niet aan het werven
-
NCT01604512Werving
-
NCT03328078WervingRefractaire hematologische maligniteit Recidiverende hematologische maligniteit
-
NCT05711251Nog niet aan het wervenLichamelijke inactiviteit
-
NCT05711056Nog niet aan het wervenOpioïde gebruik Opioïde misbruik
-
NCT05710887Nog niet aan het wervenSuïcidale gedachten Ernstige depressieve stoornis Behandelingsresistente depressie
-
NCT05710380Nog niet aan het wervenProstaatkanker Prostaat Adenocarcinoom Prostaat Neoplasma
Clinical Research Jobs
-
Senior/ Clinical Research Associate - South West England (Joining bonus £10000)
-
Senior CRA/Principal CRA - US Central Region - Oncology
-
Clinical Research Associate - FSP
-
Project Manager, Site Consultancy Services Specialist, APJ
-
Sr Optimization Specialist
-
Sr CDM Programmer II
-
Financial Analyst II
-
Drug Safety Associate ( All levels )
-
Senior Clinical Operations Leader
-
Manager, Regulatory Affairs