It is expected that any UL1 award PD(s)/PI(s) will be an established clinician/scientist who reports directly to an official with broad trans-institutional authority, and who personally has the authority and influence necessary to successfully promote translational and clinical research locally, to partner with internal and external stakeholders, support the CTSA Program activities as described below, and fully integrate the hub into the CTSA Program nationally. This may include authority, perhaps shared with other high level institutional officials, over requisite space, protected time, promotions, institutional review boards, contracting, budgeting for clinical research, and staff qualification and certification. In loosely coupled organizations that consist of university and hospital units, the CTSA Program PDs/PIs should have the authority or influence, personally or on their leadership team, to integrate these independent parts of the organization toward CTSA Program goals. If the PD/PI oversees the institution's business office, a plan on how potential conflicts of interest will be managed must be developed.
The CTSA Program PDs/PIs are expected to commit at least two person months and preferably three to six person months effort on the UL1 award annually. For CTSA Programs with multiple PD/PIs, each PD/PI must contribute at least two person months effort. The UL1 PD(s)/PI(s) may not be a PD/PI on a KL2 or TL1 award. Those with designated responsibility for defined areas of the CTSA Program should, in general, possess the knowledge, leadership, and administrative skills and capabilities necessary to direct those programs locally and to speak for the CTSA Program hub in national forums.