Sunday, July 12, 2009

Draft rules for Registration of Clinical Research Organisation

The Drug Controller General of India (DCGI) has released draft rules for registration of clinical research organisations (CROs) mandating strict adherence of standard operating procedures by the individuals, institutions or organisations conducting clinical trials in the country.

The guidelines cover all organisations, individuals, institutions and companies that take the responsibility of the initiation or management or coordination of a clinical trial even as the clinical trial sites are exempted from registration.

Click here to read the draft