This is my first post. I have a query regarding the new EU Clinical Trials Regulations that are coming into force next year. Does anyone know if there is a date agreed for implementation in the UK? I'm aware it should come into force over the summer but dates not yet confirmed.

Also is there a summary of changes available for reference? I have been through and marked out what the changes are just want to check if there is anything I may have missed.

Does anyone know if the 25 years for archiving would apply from when the regulation comes into force or if it would apply retrospectively to studies already archived?

Many thanks in advance for your help.