Bioequivalence and Bioavailability Forum

Hi vivekanand,

❝ Please suggest me that Quality assurance unit of CRO has the right to audit Institutional ethics committee of the same CRO.

❝ However QA (quality assurance) and Ethics committee operates independently.

I think this is a very interesting issue, and there are no clear answers. One thing is what is written in the contracts, another how the GCP guidance is being interpreted and by whom. You will meet different opinions about it, even among regulatory inspectors.

If I were you I would specify in the contract that the IEC can be audited by sponsor, just like the CRO can be audited. In the US some IRBs interpret their responsibility proactively and actually have their own auditors, meaning that in such cases the IRB audits the CRO.

My personal opinion is that auditing of the IEC/IRB in some cases may be a good idea. Some innovator companies do it routinely but I think it is quite rare for generic companies to do it.
Also, in my experience (which isn't a lot in this case) questions around who has the right to audit who quickly end up being resolved by means of lawyers and legal threats rather than by calm, ethical, grown-up discussions that favour the patient/volunteers.

I would be very, very interested in hearing other people's opinions here.