We are delighted to announce a major revision to our course on Good Clinical Practice. The course CT03, ICH E6(R3) Good Clinical Practice is fully up to date with the third revision of guideline E6 from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This guideline is of crucial importance to all those who undertake clinical research, whether they work in the pharmaceutical or biotechnology industry or as healthcare professionals. For the latest revision, the guideline has been radically restructured and updated.

Good Clinical Practice (GCP) is an international ethical, scientific and quality standard for the conduct of clinical research. The ICH’s guideline E6, often referred to as ICH GCP, specifies Good Clinical Practice. Compliance with ICH GCP is expected by regulatory authorities for the authorisation of clinical trials and the acceptance of their data in applications for marketing authorisation. In many countries, compliance with GCP principles is a legal requirement. 

Zenosis course CT03 discusses the role and goals of the ICH and presents the principles of GCP as set out in the third revision of its guideline E6. It describes the essential records that are to be created and maintained and the expectations for data governance. It specifies the responsibilities of trial sponsors and investigators. It explains the rationale and execution of the informed consent process, and discusses issues that arise in practice.

To view all the details and purchase the course please click here CT03: ICH E6(R3) Good Clinical Practice