Mon 16 Dec 2013 @ 16:24
Zenosis, the leading provider of eLearning for the medicinal products industry, has announced the release of a new course: An Introduction to ICH Good Clinical Practice. The course has been completely redesigned, restructured and rewritten, and it features:
- A fresh new interface
- Audio support with animation
- Immersive activities throughout
Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data in applications for marketing approval. The International Conference on Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.
This module introduces GCP and sets it in the context of typical collaborative work in clinical research. The role and goals of the International Conference on Harmonisation and the principles of GCP are discussed. The roles of members of a team working on a clinical trial are described. The documentation that must be created and maintained is set out. The responsibilities of trial sponsors, clinical investigators and monitors are specified. The rationale and execution of the informed consent process is explained, and issues that arise in practice are discussed.