Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)

Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)

An integrated amendment of the ICH E6; Guideline for Good Clinical Practice, has now been released and became effective in the EU on 14 June 2017

The amended version of the international guidelines for GCP, ICH-GCP E6(R2) has been modernised for the first time in twenty years. The updated guideline attempts to reflect significant technological advancements in clinical trials such as the use of electronic data recording and reporting and the adoption of risk-based approaches to quality management. This is to encourage more streamlined approaches to clinical trial design, conduct, oversight, recording and reporting.

Whilst most of the changes are in respect to Sponsor responsibilities and risk-based monitoring, there are some Investigator/Institutional changes.

The full version of the ICH-GCP E6(R2) can be found here.