CRU Responsibilities

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