Dear All,

I wonder if anyone have any recommendations/advice in relation to the following:

we have an ongoing trial that started on ICH GCP (R1), the trial will go on for another year or so and since we have the R2 coming into effect in June? there are more details in R2 related to investigator responsibilities and sponsor's responsibilities in addition to other amendments and we want to ensure that we do things correctly, please can you provide any guidance or thoughts on how to manage this situation?

Thank you