Sponsor Oversight of CRO SOP Compliance
Sponsor Oversight of CRO SOP Compliance How Sponsors Can Monitor CRO SOP Compliance Effectively Introduction: Why Sponsor Oversight of CRO SOPs Is Critical Outsourcing clinical trial activities to Contract Research Organizations (CROs) has become the norm. However, outsourcing does not absolve the sponsor from responsibility. As per ICH E6(R2) and FDA regulations, sponsors are accountable…