02 Jul ICH GCP Guideline (GCP Addendum) E6 (R2) became final in November 2016.
It encourages the implementation of more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.
The ICH GCP Addendum E6 (R2) from Nov.2016 provides a unified standard for the mutual accptability of clinical trials globally and supersedes the previous ICH E6 (R1) GCP guideline.
GCP addendum was developed to address the increased scale, complexity, and cost of clinical trials. It includes the advances that have been made in electronic data recording and reporting technologies, as well as the implementation of other approaches such as:
- Risk-based quality management
- Risk-based monitoring
- Requirement for oversight by investigators and sponsor when delegating and outsourcing respectively.
The changes have impact on sponsors and investigators, but greatest impact on sponsor.
It is estimated by the authority (e.g. FDA), that it will be a time-consuming process for sponsor to implement two key requirements of the revised guideline:
- Developing and implementing a quality management system
- Describing the quality management approach, while summarising any important deviations from predefined quality tolerance limits and any remedial actions in relevant clinical study reports.
PharmaGCP has prepared implementation guides for investigators and sponsors. They contains all the changes and overall recommendations on how to implement the changes.