I would be interested in knowing what are the expectations in terms of PI's responsability, if say, a PI is dead or removed from his responsabilities and there are patients still ongoing at the site.
is it appropriate to wait for the EC to approve the new one and not perform any study related activities in the meantime, or would a current SUB-investigator be entitled to keep assessing the patients' safety as per protocol?
Expecially if it takes 4-5 months to the EC to approve the new PI, I guess there are GCP /legal/insurance implications in not assessing the patients as per protocol in the meantime, even if the patients are seen as per normal practices (and therefore their safety is not at stake, strictly speaking)?
thanks
Federica