Clinical Research Support Office/CRSO
ii) Support in Achieving Patient Safety and Regulatory Management and Compliance
Patient safety and research compliance are supported by all hospital and clinical research departments. Oversight of DSMP conduct will include informal and formal elements.
Informal oversight allows the CRSO to provide real-time assistance, identify areas for educational intervention and compliance focus prospectively, and make on-the-spot corrections to practice that enhance safety and regulatory compliance.
Informal elements include attendance of Clinical Research Support Office staff at:
- Weekly staff multidisciplinary rounds,
- Weekly research team rounds, when appropriate,
- Biweekly GCP Workgroup.
Formal monitoring of the conduct of the DSMPs includes:
- Annual review of Protocol Progress Reports submitted as part of IRB continuing review,
- Real-time review of all serious adverse events (SAEs) and unanticipated adverse events (UAEs), and DSMP protocol violations or deviations reported by the principal investigator (PI), Nursing, or the Nurse/Monitor,
- Early audits of new investigators or complex protocols,
- For-cause audits,
- Not-for-cause audits,
- Comprehensive and routine auditing activities meeting the standards of GCP-International Conference of Harmonization (ICH GCP).