Accreditation of Clinical Trial(Ethics Committees) : Introduction
National Accreditation board for hospitals and Healthcare Providers (NABH), Quality council of India has developed a system of accreditation for Ethics Committee (EC).
Applicant is ethics committee and accreditation shall be granted to them as per details and scope provided in the application form.
Ethics Committee Accreditation is a public recognition by a National Healthcare Accreditation body, of the achievement of accreditation standards demonstrated by an Independent external peer assessment of ethics committee’s level of
performance in relation to the confirmed standards.
It is important that all pharmaceutical products go through a standard quality, safety and efficacy study, both during the pre-marketing evaluation and also during the post-marketing review.
For that purpose, clinical trials are conducted.
Accreditation is an incentive to improve quality as well as capacity of registered Ethics Committee to confirm an ethical research on new drugs.
Confidence in accreditation is obtained by a transparent system of monitoring over the accredited ethics committee and an assurance is given by the accreditation body that ethics committee constantly fulfills the accreditation criteria.