The ICH GCP E6 (R1) guideline had been around since 1996. With the world changing at a very fast pace with increases in globalization, study complexity and technologic capabilities an update was long due. The ICH GCP E6 Addendum took effect in November 2016, offering an improved and more efficient approach to clinical trial design, oversight, conduct, recording and reporting to even better ensure human subject protection, quality of data and efficiency of industry. More specific recommendations are made to facilitate innovative clinical trial approaches including quality risk management and quality-by-design processes which emphasize upfront assessment of risks specific to a study design and protocol.
This TRIUM Session provides a to the point update on what exactly changed compared to the ICH GCP E6 R1 version. But most importantly it will cover the impact on the sponsor- and investigator’s responsibilities and the overall daily research reality of both. A refresher of the IRB/EC responsibilities will be covered as well to complete the full story.
At the end, you will receive a certificate for attendance and handy hand-outs for use in the field.
By the end of this TRIUM Training you should be able to:
- Describe the investigator, sponsor and IRB/EC responsibilities
- Describe what changed in ICH GCP E6 R2 and why
- Critically assess the impact for sponsors and investigators of these changes
- List actions to be taken in the daily research environment to ensure compliance with ICH GCP E6 R2
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.