Enhancing quality in clinical trials after implementation of new ICH E6 R2 addendum

Based on the experience from working in the industry, with the industry and experiences from inspecting clinical trials (sponsor, investigator and CRO site inspections), the risk-based concepts and the black box of electronics including the eTMF seems to be challenging.
Traditionally, monitoring has been set to be 100 % source data verification and everything else was also checked 100 %. Over the past decade this has gradually changed and the concept of having a risk-based approach developed within the world of clinical trials and the industry.
The ICH GCP from 1996 (R1 version) already include an option for the sponsor to have risk-based monitoring. “The sponsor should determine the appropriate extent and nature of monitoring.” The revised ICH GCP (R2) highlighted the risk-based concept and built it into virtually all aspects of the guideline. The ICH GCP (R2) also specifies a lot more clearly the expectations for electronic systems and the transformation from paper to electronics. A transformation that causes a lot of new challenges and questions.
When it comes to the Trial Master File, the new Clinical Trials Regulation 536/2014 defines it to be the key for supervision of the trial for all parties (monitoring by the sponsor and inspection by Member States).

During the course we will try to go through how to read the guidelines and legislation and how to interpret authority and regulators expectations. Each individual trial, company and environment does not fit into one size, but we will bring you knowledge that should enable you to develop trial setup and procedures relevant for your tasks. The course will enable you to ask questions and discuss. The course will also allow you to put forward your question anonymously, if you prefer this. The training leaders will try to include questions asked before the course and discuss them during the relevant sessions (anonymously).