Current Edition

Tipping Point of Risk-Based Site Monitoring – Is it Within Reach?

With the recent 2011 release of the FDA’s draft guidance on risk-based approaches to monitoring, the agency has sought to correct a long-standing misconception that 100 per cent source document verification (SDV) is a regulatory requirement. Additionally, in issuing this draft guidance, the FDA took the further step of encouraging alternate, risk-based monitoring approaches while reaffirming that 100 per cent SDV is not a regulatory mandate. Sean Cheng at Medidata Solutions discusses that there are more efficient strategies to ensure the safety and integrity of patients and data.