Bioequivalence and Bioavailability Forum

Dear all,

Thanks for the reply. Just one more clarification. We have got our inhouse Diagnostics and we run the internal quality standards on the day the samples are analised. Do we still require a Pathologist to countersign the reports? Is it absolutely necessary or our our technician's signature in the reports (after taking printout from the instruments) is sufficient?
Similarly who can certify the ECG and X-ray reports? Can the Physician/Investigator (medicine graduate only) can certify or it has to be certified by a relevant specialist? What is the regulatory requirement?

Thanking you in advance.

drgopal