Clinical Research Support Office/CRSO

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ii) Support in Achieving Patient Safety and Regulatory Management and Compliance

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.

  1. 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).