Dear All,

I was wondering if you can help/recommend with regards to the following:

we have an ongoing trial that started on ICH GCP R1 and is likely to carry on for a year or so, since we have R2 coming into effect in June this year. we are looking for any guidance on how we manage/assess this situation for the current trial to ensure that we are following the correct guidance and so any help and recommendation will be much appreciated

Thank you