3 things you need to do to prepare for the EU Clinical Trials Regulation

At the time of writing the application date for the Clinical Trials Regulation is going to be the end of January 2022. It’s been a long time coming – the original anticipated date was in 2016 – and so we’ve been talking about this for the last 6 years. The danger now is that many people will not be ready for implementing the requirements because we are so used to the date being postponed. There are therefore some key things I recommend that we need to start doing now (if you haven’t already) so we can be ready for the implementation.


1. Get ready for the CTIS


The European Medicines Agency (EMA) is working with various groups to provide training and support for use of the Clinical Trials Information System (CTIS). This is the database which will replace EUDraCT and will be the central portal for all applications and reports for clinical trials in the EU. There will be a number of user roles for the system and so your organisation needs to identify who will take on these roles and they can then access training and support for their role. There is an information and training page on the EMA website where you can find out more about how the system will work and the training that’s available. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation/clinical-trials-information-system-ctis-training-programme


2. Legislative changes Gap Analysis


The Regulation will introduce various new requirements. Some of these are major changes, for example the Clinical Trials Authorisation procedure, and some are minor, for example the change in terminology from Amendment to Modification. These changes will mean that significant updates will be needed to Standard Operating Procedures, processes and policies. We need to be working on this now so that our documents are ready to go for the Regulation implementation in January 2022.

My advice would be to set up a cross functional task force to review the legislation, identify the changes and the documents and processes that will be impacted, and then to create an action plan to address the changes needed. Make sure to include all the departments and functions impacted by the changes so that they can discuss overlaps and develop a cohesive approach to implementation.


3. Training for everyone!


We need to set up and roll out an internal training strategy to ensure that everyone in the organisation knows how this impacts their role. We often see a “one size fits all” approach to GCP training, but that WILL NOT WORK in this situation. Training needs to be role specific and address the changes that each department and function will need to implement, otherwise the content will be overwhelming.


I’d love to hear your ideas and experiences so please do comment below if you have anything to share.

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