Clinical Research Support Office/CRSO
ii) Support in Achieving Patient Safety and Regulatory Management and Compliance
Oversight of DSMP conduct will include informal and formal elements.
- The informal elements include attendance of Clinical Research Support Office staff at:
- Weekly staff multidisciplinary rounds,
- Weekly research team rounds,
- Weekly nursing rounds,
- Monthly coordinator rounds.
Informal oversight allows the CRSO to provide real-time assistance, identifying areas for educational intervention and compliance focus prospectively, and making on-the-spot corrections to practice, and knowledge.
- Formal monitoring of the conduct of the DSMPs includes:
- Annual review of Progress Reports submitted as part of IRB continuing review, (IRB Procedures, section 13;)
- Quarterly review of all adverse events (AEs),
- 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.
- For-cause audits
- Not-for-cause audits
- Comprehensive and routine monitoring and auditing activities meeting the standards of GCP-International Conference of Harmonization (ICH GCP).