Clinical Trials Pilot Project Program
Abstract: (250 words)
- Provide succinct summary of your pilot clinical project
Specific Aims (1 page)
- Follow the NIH R01 guideline for the Specific Aims section; include a brief narrative and a breakdown of the proposal’s aims
Significance (1 page)
- Include the significance your pilot project will generate to human health, UT Health San Antonio’s clinical operations, and to LSOM clinician researchers and learners
Potential for therapeutic impact/drug development (1-2 pages)
- Briefly describe the therapeutic impact on patient care at a local level in South Texas and throughout country. Describe how your project contributes to drug discovery and development at UTHSCSA
Team Roster, Roles, and Required Activities (1 page)
- Provide a brief description of the team roster to include (click here for an example diagram). Team members should include a Primary investigator: Senior clinician and/or basic science researcher; Co-investigator(s): Junior clinical and/or basic science faculty; Advanced UT Health Learners (minimum 1 member) such as a resident, fellow, or medical/graduate student to promote comprehensive mentorship; Optional: Collaborators from other San Antonio Institutes. A team representative will take part in the Office for Research’s Grant Development Program, led by Dr. David Gius, to draft the final clinical trials grant, and a member will attend quarterly luncheons to discuss project status
Letter of Support from Department Chairs or Division Chief
Budget and Justification (1 page)
- Itemize requested funding. Facilities and Administrative (F&A, indirect cost) expenses are not reimbursable. Funds are not applicable to support the salary of the PI(s), faculty-level collaborators, or graduate students. While the candidate will list themselves as the PI in the personnel section of the summary page, there is no minimum effort requirement. Candidates may list salary (plus associated fringe benefits) for non-faculty support staff, including post-doctoral fellows. Other allowable expenses include: equipment essential for the project (maximum $10,000, including computer hardware); PI or Co-PI travel to relevant scientific meetings (maximum $1,500); consumable laboratory supplies; animal purchase and per diem; IIMS, CTRC, GCCRI, UTSA, or other core facility fees; consultation fees (maximum $5,000); computer time; software; publication/ presentation expenses; costs related to human subject enrollment and management (listed as “Patient Care Costs” on budget page). Other expenditures require justification as being essential for the completion of the project. LSOM will centralize all account management.
- All review committee members are tenure track, and have a long-standing history of extramural funding, and peer-review experience. The committee reflects the diversity of LSOM research as members include basic and clinical departments.