Internal and external review of research conduct
During the oversight stage, internal and external representatives review the conduct of the research to ensure adherence to the protocol, SOPs, and applicable federal law and international guidance. This stage may overlap with the Activation, Conduct, and Publication stages. Prospective studies undergo routine internal monitoring via the Regulatory Affairs / Quality Assurance Unit of the CTRO, with opportunities taken for re-education / training on Clinical/Translational Research SOPs, as needed.
External monitors or auditors from Sponsors or Sponsor-representatives may also come onsite or conduct remote monitoring during this stage.
During this stage the following centralized support groups / shared services may be engaged:
- Research Operations
- Clinical Research Unit (CRU)
- Investigational Drug Services (IDS)
- Research & Grants Administration
- Post Award Activities
- CTRO RA-QA Monitoring Plan