Auditing is a systematic, independent examination conducted to ensure compliance with regulations and standards at a given moment in the clinical trial. The focus of the audit is process based and involves corrective and preventative actions to ensure ongoing compliance.
Monitoring, on the other hand, involves ongoing continuous oversight of study activities and data to ensure adherence to the protocol and identify issues in real-time.
Request an Audit
Please complete the ORQA Audit Request Form. An ORQA member will contact you shortly.
Request a Quality Initiation Meeting with ORQA
The goals of our Quality Initiation (QI) meetings are to review the team’s quality management plan and discuss strategies to proactively build quality into research processes and study conduct before enrollment. Following the study’s initial enrollment, our team will conduct an educational review of the study’s processes and provide feedback to the team.
Please complete the Quality Initiation Meeting request Form to request a Quality Initiation (QI) meeting. An ORQA team member will contact you shortly.