Frequently Asked Questions
Why are CRAUs needed?
CRAUs are needed to enable the SOM to accurately account for the portfolio of clinical research projects and personnel across the School. CRAUs will also promote efficiency and compliance through effective communication and standardization of processes.
What is the role of the CRAU?
The CRAUs will function primarily to aid in communication: to ensure information is appropriately disseminated to study teams and personnel and to communicate challenges faced by study teams to the CRSO. CRAUs will also verify metrics and data related to personnel and studies under its purview and promote adoption of standards and best practices. Specific activities that CRAUs will manage include reviewing study feasibility assessments, aggregating monitoring and audit review findings, and tracking staff allocations and competencies.
I already have a wonderful team that manages my portfolio of clinical research projects. Can we set up our own CRAU?
No, CRAUs are not synonymous with or meant to replace existing operational teams. Your team may continue to function as the primary direct support for your portfolio of clinical research projects but will fit into the broader infrastructure of a CRAU as well. However, a departmental CRAU may designate your team as a functional sub-CRAU.
I do research in a few different therapeutic areas, sometimes working with centers. How do I know which CRAU I will work with?
Except for IGHID and LCCC, CRAUs will have accountability for the studies led by PIs whose primary appointment is in that department. This means your research will typically be accounted for by the same CRAU (your home department), regardless of where your study is being conducted. Independent of the CRAU structure and affiliation, centers and other units may have additional required processes specific to administering or managing clinical research projects with their units.
If you are conducting a study in collaboration with IGHID or LCCC, those CRAUs will communicate to you any specific processes required for working with their CRAU.
Will CRAUs offer direct support and personnel to manage research projects?
CRAUs are not required to provide direct support and/or personnel to manage research projects, but some may choose to do so. Each CRAU will choose how to establish their operations and that information will be available in the CRAU charter descriptions included on this webpage.
Is this an effort to centralize all research support across the SOM?
No, CRAUs are not intended to centralize research support or activities. Rather, CRAUs are being created to establish a standardized organization for clinical research across the SOM. This standardized organization will support effective communication across the dynamic research units and teams of the SOM and help to accurately account for all studies and personnel.
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