A webinar will introduce academia and small enterprises to the new Clinical Trials Information System (CTIS) and the incoming EU Clinical Trials Regulation.
CTIS will be launched at the end of January 2022, and will gradually replace the existing European EudraCT trial registry for drug trials. At the same time, the EU Clinical Trials Regulation will fully come into force, and national medicines regulators across Europe will get legal powers to fine institutions and comopanies that fail to make clinical trial results public.
Organised by the European Medicines Agency, the 29 November event (held online 09:00-13:15 CEST) will cover the following topics:
Overview of the Clinical Trials Regulation
Introduction to the new process for submitting clinical trial information
Functionalities of CTIS including transparency aspects and safety reporting requirements
Guidance and training material available for sponsors
OTHER USEFUL CTIS RESOURCES
To prepare for CTIS, trial sponsors can access the following resources:
The CTIS training and support page now contains guidance on the data fields that clinical trial sponsors will need to fill in CTIS when submitting a clinical trial application and managing a clinical trial.
In addition, EMA is seeking user feedback on the CTIS Sponsor Handbook. If you think that there are any additional questions that the handbook should address, or if you found some sections unclear or confusing, please fill out this survey so that EMA can improve it.
MORE CTIS TRAININGS AND SUPPORT COMING
Clinical trial sponsors can now apply for access to the “CTIS Sandbox” (CTIS training environment). Click here to apply.
The CTIS Highlights Newsletter provides updates on forthcoming training sessions and the CTIS rollout:
To subscribe to future issues of the newsletter, email email@example.com