The responsibilities for the Medicine CRU are to:
- Ensure that costs for clinical research activities are understood and covered
- Ensure that the targeted population is understood and monitored
- Ensure that faculty and staff involved in clinical research are appropriately identified, trained and qualified
To this end, the Medicine CRU will:
- Develop and maintain standard operating procedures for good clinical practice;
- Develop and monitor standard operating procedures for the financial management of clinical research awards involving human subjects;
- Build a sense of community among PI’s, clinical research coordinators, research and financial practice managers, and grant administrators with the goal of elevating individual and collective expertise;
- Develop and monitor quality assurance programs;
- Develop and maintain on-boarding programs for faculty and staff, resources in print and on-line that provide guidance and aid research activities.
The Medicine CRU will provide oversight related to:
- The safety and welfare of research participants
- Study feasibility: both clinical and financial
- Budget preparation and negotiation
- Study-specific financial management to include pre- and post-award administrative and financial oversight; budget preparation, reporting, and invoicing that ensures proper invoicing, and reconciliation of payments;
The Medicine CRU will provide resources to assist the divisions to:
- Prepare and participate in internal and external audits
- Facilitate interactions with the Institutional Review Board
- Facilitate interactions with the SOM Research Support Offices (Duke Office of Clinical Research, Office of Research Administration and Office of Research Contracts, etc.)
- Provide accurate reporting of research data to both the DoM and SoM
- Avoid clinical trials that would create real or perceived conflicts of interest