India’s Central Drugs Standard Control Organization (CDSCO) has drawn up guidelines for regulators and sponsors to help tighten up clinical trial inspection procedures. The stricter guidelines aim to increase the credibility and integrity of clinical trial data, helping increase compliance with drugs and cosmetics regulations. The CDSCO claims a tighter framework will provide direction for inspectors and CDSCO officers when conducting inspections of sponsors, CROs (contract research organisations) and clinical trial sites.
CDSCO headquarters say “inspection of clinical trial sites would generally be pre-announced,” but insist that spot-checks may occur “under some specific circumstances”. Inspection of the CRO or trial sponsor can still be conducted without prior notice.
Posted by Bruce Lehr November 18th 2010.