Wed 22 Mar 2017 @ 14:38
Zenosis, the leading provider of eLearning for the medicinal products industry, has announced the release of a substantially updated version of its course CT03: An Introduction to ICH Good Clinical Practice. Version 2.2 of the course is fully up to date with Revision 2 of Guideline E6 from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The revision takes account of the evolution of clinical research performance from a largely paper-based process to one embracing electronic data recording and reporting. It is intended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results. In a major development, sponsors are now required to implement quality management of their clinical trials using a risk-based approach. Other changes to the guidance affect the monitoring of clinical trials, oversight of activities delegated by sponsors and investigators, management of records, and much more.
It is essential that all clinical staff of pharma/biotech companies and contract research organisations, clinical research associates, and healthcare professionals involved in clinical trials are trained in the revised guidance. This course provides a cost-effective training tool.
The ICH E6 guideline, often referred to as ICH GCP, is the standard specification for Good Clinical Practice, a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials of new medicines. 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 approval to market the medicines.