Medical Center + Community = Clinical Research

1. Medical Center + Community = Clinical Research • Participant and Clinical Interactions Resources • Form 1572 Obligations • Budgeting for clinical trials • CRC and other facilities • Resource tools: guidelines for developing SOP, lapel buttons for recruiting PI lifeline • Community Research Advisory Board

2. 1572 and You Obligations of the PI

3. Contract • Agreement between sponsor and PI • Meets requirements of Food and Drug Administration regarding evaluation of drug.

4. Responsibility • All aspects of the investigation: • Protocol • Personnel • Protection of subjects • Procedure and data integrity • Proof: Documentation

5. Commitments • I agree to conduct the study(ies) in accordance with the relevant, current protocol(s) and will only make changes in a protocol after notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subjects.

6. Commitments • I agree to personally conduct or supervise the described investigation(s).

7. Commitments • I agree to inform any patients, or any persons used as controls, that the drugs are being used for investigational purposes and I will ensure that the requirements relating to obtaining informed consent in 21 CFR Part 50 and the institutional review board (IRB) review and approval in 21 CFR Part 50 are met.

8. FDA Documents www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.htm www.fda.gov/OHRMA/DOCKETS/98fr/FDA-2008-D-0406gd1.pdf

9. Code of Federal RegulationsTitle 21 • Codification of general and permanent rules published in the Federal Register by Executive departments and agencies of the Federal Government. • Title 21 is reserved for rules of the Food and Drug Administration

10. Part 50 • Protection of Human Subjects • General requirements for Informed Consent • Exception from general requirements • Elements of Informed Consent

11. Part 56 • Institutional Review Boards (IRB) • General provisions • Organization and Personnel • IRB Functions and Operations • Records and Reports • Administrative Actions for Noncompliance

12. Commitments • I agree to report to the sponsor adverse experiences that occur in the course of the investigation(s) in accordance with 21 CFR 312.64. • I have read and understand the information in the investigator’s brochure, including potential risks and side effects of the drug.

13. 21 CFR 312 • Investigational New Drug Application • General Provisions • Investigational New Drug Application (IND) • Administrative Actions • Responsibilities of Sponsors and Investigators • Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses

14. Commitments • I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study(ies) are informed about their obligations in meeting the above requirements. • I agree to maintain adequate and accurate records in accordance with 21 CFR 312.62 and to make those records available for inspection in accordance with 21 CFR 312.68.

15. Commitments • I will ensure that an IRB that complies with the requirements of 21 CFR Part 56 will be responsible for the initial and continuing review and approval of the clinical investigation. I also agree to promptly report to the IRB all changes in the research activity and all unanticipated problems involving risks to human subjects or others. Additionally, I will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.

16. Commitments • I agree to comply with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements in 21 CFR Part 312.

17. Support Services To Help You • HSPPO • IRB • OCRSS • HSCRO • CTSI

18. Owensboro Jewish Hospital Center For Advanced Medicine Anesthesia Research UofL CRC AHEC UofL Outpatient Clinics KCPCRU UofL Body Composition Laboratory Kindred UofL Children’s Obesity Clinic OCRSS Brown Cancer Center ICR VA Neurosciences (KSCIRC, NeuroRecovery, Movement Disorders) Sickle Cell Project JCPS Environmental Health (NIEHS P30, mobile van) Trover Clinic

19. CTSI • CRC and other facilities • Resource tools: guidelines for developing SOP, lapel buttons for recruiting PI lifeline • Community Research Advisory Board

20. UL Clinical Research Center University of Louisville Hospital 6S http://louisville.edu/research/clinicaltrials/about/university-clinical-research-center-services.html

21. UL Clinical Research Center • Inpatient Room • Outpatient Area • 2 exam rooms • 1 monitored bed (can be used for 23 hr admit) • Lab • Phlebotomy station • Specimen freezers (-20, -80) • Refrigerated centrifuge

22. UL Clinical Research Center • Hospital location allows access to ancillary services (radiology, dietary, pharmacy, etc) • Staff are research certified RN’s

23. UL Clinical Research Center Purpose: assist UL Investigators with the clinical aspects of conducting study visits • Use of facility • Use of staff for off-site visits • Use of staff and facility

24. UL Clinical Research Center • Draw, process, store or transfer specimens • Serve as unblinded coordinator • Serve as primary or secondary coordinator • Conduct PK portion of Phase I trials • Serve as infusionists • Provide extended observation periods post-procedure

25. UL Clinical Research Center To utilize our services: Contact Karen Beatty 562-4797 or karen.beatty@lousiville.edu Submit protocol for review to ensure resource availability

26. UL Clinical Research Center http://louisville.edu/research/clinicaltrials/about/university-clinical-research-center-services.html

27. CRC Facilities. Three bed outpatient evaluation area

29. Resources • Guidelines for developing SOP http://louisville.edu/research/clinicaltrials/investigators • PI lifeline • Lapel buttons for recruiting

30. Owensboro Jewish Hospital Center For Advanced Medicine Anesthesia Research UofL CRC AHEC UofL Outpatient Clinics KCPCRU UofL Body Composition Laboratory Kindred UofL Children’s Obesity Clinic OCRSS Brown Cancer Center ICR VA Neurosciences (KSCIRC, NeuroRecovery, Movement Disorders) Sickle Cell Project JCPS Environmental Health (NIEHS P30, mobile van) Trover Clinic

32. Community Research Advisory Board • Composed of lay representatives from rural (AHEC), mountain (Prestonburg), ethnic and under-represented minorities (African American, Hispanic), workers (UAW Ford) and support groups (cancer, heart disease, diabetes, mental health); bench and clinical investigators; and community physicians.

33. Community & Research Engagement Advisory Board Luther L. Brown, Jr. The Strothers Association Eboni Cochran West End Martha Neal Cooke Healthcare Jay P. Davidson The Healing Place Rudy Davidson West End Randa Deaton Ford Brenda Fitzpatrick Northwest AHEC Anne Hagan Park DuValle Health Center Diane Hague, LCSW Seven Counties JADAC Dr. John Huggins Kentucky African Americans Against Cancer G. Henry Hunt Dataseam

34. Community & Research Engagement Advisory Board Pam Temple Jennings Kentucky Cancer Program Alfred B. Jenson , MD Basic Scientist, UofL Mary C. Lyle Ford Jean Marshall AA, Stroke Rep. Reginald Meeks Kentucky Legislature    Patrick McKiernan CADC, KY Dept for V. Affairs Kathy Renbarger American Heart Association, Great Rivers Affiliate Norma Mason Sikes Faith Based Flora Ponder Geriatrics Stephanoe Poynter, DMD Family Health Center Portland Charles Woods, MD Clinical Investigator, UofL

35. CareRAB objectives • Evaluate therapeutic modalities such as drugs and biomarkers candidates for Phase II-IV clinical trials in the communities they represent. Their evaluation and input will start at the preclinical phase. Set priorities for the CTSI/UofL that involve participants/patients in community/clinical based research. • Advise investigators on social, education, and research needs of the community. Bring and facilitate others to bring research projects to the Board or through the CTSI Web Portal, “Starting Gate”. • Facilitate the participation of their constituents in clinical research. Lay members will be advisors for education and clinical trial information distributed to their constituents. • Participate in all specific aims and evaluation of the CSTI CARE Core.

36. Clinical Research • Introduction of new clinical research investigators/staff. • Questions/challenges?