Oversight of DSMP conduct will include informal and formal elements.

1. The informal elements include attendance of Clinical Research Support Office staff at:
1. Weekly staff multidisciplinary rounds,
2. Weekly research team rounds,
3. Weekly nursing rounds,
4. 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.

2. Formal monitoring of the conduct of the DSMPs includes:
1. Annual review of Progress Reports submitted as part of IRB continuing review, (IRB Procedures, section 13;)
2. Quarterly review of all adverse events (AEs),
3. 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.
4. For-cause audits
5. Not-for-cause audits
6. Comprehensive and routine monitoring and auditing activities meeting the standards of GCP-International Conference of Harmonization (ICH GCP).