Today’s the day the EU CTR comes into effect. This new legislation will majorly impact organizations involved in the design and implementation of clinical trials.
Our previous blog covered the fundamentals of this new regulation and what made it different from the previous Clinical Trials Directive that it replaced. EU CTR brings harmony between member states and makes cooperation on clinical trials more straightforward while improving transparency to the public. It also brings improved safety standards while facilitating practical and improved submission and assessment procedures between member states.
But the question we’re asking is are you ready to implement the EU CTR in your team?
Here are some factors you might need to consider.
Internally, you may need to analyze the EU CTR’s impact on your processes and SOP’s. There may also impact your organizational structure, systems, and how documents are managed. It’s also important to check your current trials that may align with the CTD and transition from this to the EU CTR.
Are all your documents updated and compliant? Are your deferral strategy and request procedures in place? Is everything ready for public presentation in the name of transparency?
And most importantly, are your staff trained in their new responsibilities?
We’ve developed a checklist to help you get EU CTR ready – click here to get your copy.
GCP Central can help you be EU CTR Ready
We’ll be at the EUCROF 6th European Conference on Clinical Research, where you can pick up a physical copy of our checklist, and discuss all your training needs to get your team EU CTR compliant.
Marieke will be there in person, so stop by and talk about options with her (or book an online meeting), or if you’re attending virtually, stop by our online booth and check out our range of EU CTR courses. Get EU CTR ready with GCP Central’s training solutions, tailor-made to fit the needs of busy research professionals.
Visit our webshop and between January 31st and February 6th, use the code CTRLIVE to take 10% off a purchase of 5 or more training licenses