1. How To Impact Your Research: An Overview of Research Support Services Quincy J. Byrdsong, Terri Hagan, and Alice Owens-Gatlin Research Services Consultants

2. Objectives To communicate the vision of a dynamic research enterprise at Vanderbilt To discuss the overall purpose of Research Support Services and its position in the schematic of the Office of Research To outline the educational and support mechanisms of Research Support Services To discuss the goals and functions of Project IMPACTT

3. The Vision Create a full-service oriented organization designed to improve the research process and ultimately, the quality and safety of human and basic research at Vanderbilt. Eliminate research administrative processes as a barrier to conducting research Become a critical value added service for the institution by supporting growth of the research enterprise through initiatives of importance Feedback Educate Evaluate Feedback Educate…

4. Purpose of Research Support Services To provide access to personnel with the expertise to guide investigators through the human subjects research process, and provide support in navigating the Vanderbilt system To serve as a liaison between the investigator or study personnel and the entities which comprise the VU research enterprise

5. Office of Research Gordon Bernard, M.D. Assistant Vice Chancellor for Research Institutional Review Board Research Support Services Jill Pulley, Director Quincy J. ByrdsongTerri HaganAlice Owens-Gatlin Grants and Contracts

6. Education Afternoon Delights Town Hall Meetings GCRC Research Skills Workshop Department Rounds Committee Meetings

7. Individualized Support IRB Forms Grant Submission Funding Opportunities Communication with Sponsors IND/IDE guidance Study Design

8. Study Team Support Building the research team Creating committees Guiding study design Navigating study team through the research process from idea to implementation

9. Current Projects Supporting the organization of the Clinical Research Staff Council Creating the Orientation Manual for clinical research staff Developing an review program to educate regarding percent effort of faculty and key study personnel Troubleshooting survey of key study personnel to assess research needs

10. History of IMPACTT NIH/OHRP offered grants to Institutions in an effort to improve Human Subjects protection VUMC awarded funds for Project PROTECT (enhanced IRB application) Follow-up award for Project IMPACTT which was based on OHRPs QA/QI program

11. Specific Aims Grounded in the principles of continuous quality improvement, this program will provide: –e–e–e–educational resources, –s–s–s–self-assessment tools, and –t–t–t–technological support to investigators and staff.

12. IMPACTT Process Request by, or randomly select an Investigator to visit Initial pre-assessment interview to communicate the goals of the IMPACTT program On-site assessment on a single protocol utilizing a comprehensive assessment tool developed to examine the necessary elements involved in managing a research study

13. IMPACTT – Goals of the Visit Assist the research team in identifying strengths and weaknesses Provide education Make recommendations for improvement in the Investigators research program

14. IMPACTT - Measures of the Assessment Tool Regulatory Documents IRB Documentation Participant Records/Consent/ Selection Criteria/Adverse Events Record Keeping Responsibilities

15. IMPACTT - Outcomes An exit interview is conducted at the conclusion of the on-site assessment A final report which includes the findings and recommendations is then issued by the IMPACTT team –The report includes an assessment of each area A return visit will be scheduled based the needs identified –The return visit will be designed to re-assess the focus areas to measure improvement An evaluation is obtained from the Investigators and coordinators to assess the response to the IMPACTT initiative

16. BENEFITS Its informative Its free It provides an open forum for questions and answers Its comprehensive Its confidential Its quick and relatively painless It gives a fresh set of eyes to assess your research study/program

17. How Do I Sign Up? Complete a IMPACTT Program Request on-line Complete a IMPACTT Program Request on-line Send an email to: Research.Support.Services@vanderbilt.edu Send an email to: Research.Support.Services@vanderbilt.edu Research.Support.Services@vanderbilt.edu Give us a call on the hotline *322-7343* Give us a call on the hotline *322-7343*

18. Questions?