Bioequivalence and Bioavailability Forum

Hi Norah,

there are no well-defined rules. But I assure you that you don't want to be in a situation where you haven't done it and it then causes issue downstream. It is going to be your problem and the sponsor's problem regardless of IEC+regulatory approval.
Section 3 of ICH E6 in a way gives the IEC/IRB some "responsibility" for rights, well-being, safety of trial participants. In practice though this is a bit messy and does not mean the CROs/Sponsor's responsibility is offloaded on a bureaucratic parallel universe if something happens.

Chest Xray and ECG are a bit in the same category. They are not done routinely in certain parts of Asia.

I don't know where the limit is. You can die from infection from an in-grown toe nail, yet I never saw any source or CRF mentioning a specific check for this condition was done.