EMEA have revised the Q&A document in chapter V of Eudralex Vol 10.

The changes are as follows:

New Question 3: Clarifies that a commercially available product used as a comparator in a clinical trial is considered to be IMP.

New question 4: Defines a non-interventional trial to clarify that these are not subject to GCP.

Revised question 8: Clarifies that the sponsor can delegate duties/tasks but remains RESPONSIBLE for the clinical trial.

Revised question 18: Annual safety reports can be aligned with PSURs and/or IND Annual Reports provided this results in a shortened reporting time and not a lengthened one.