Internal awareness and training
You may have been trained or read the Regulation back in 2014 when it was issued, but a lot has happened since then, be it the Clinical Trials Information System (CTIS) or several implementation guidance texts.
Beyond these documents, the framework of the implementation is now clearer, requiring companies to evaluate their gap with current practices and decide on their implementation strategy. From Management to Operations, the first step is to raise internal awareness around all these aspects.
We have developed several training modules to address the various needs of our clients (see the list below). They can be delivered in-house by one of our EU CTR experts, and they include quizzes, Q&A sessions and use cases.
Special needs can also be evaluated, and presentations can be tailored for you. Do not hesitate to reach out to ObelysQ to discuss how we can help you train your staff for the EU CTR.
- Module 1: Overview of the CTR 536/2014
- Module 2: Focus on CTA submissions
- Module 3: Focus on new concepts of the CTR
- Module 4: Focus on Transparency
- Module 5: Focus on CTIS
- Module 6: Focus on CTR implementation strategy and related organizational changes
Why not start with an e-learning session? We have created a shorter version of Module 1 in that format to facilitate deployment to a larger or geographically spread-out group. With our e-learning “Overview of the CTR 536/2014” you can establish a baseline of knowledge for all relevant stakeholders.