1. A Road Map to Clinical Research at Jefferson

2. Required Training; prior to research activities: CITI Training COI (Conflict of Interest) eMR systems TJU/TJUH required Health Stream Modules, clinical competencies and licensure Infectious materials shipping training SOPs

3. CITI Training: Collaborative Institutional Training Initiative at the University of Miami http://www.jefferson.edu/content/dam/tju/human_research/irb/CITIIRBTrainingInstructionsDec2011.pdf 1.Basic Human Subject Protection (HIPPA incl.) 2.Good Clinical Practice (GCP) http://www.jefferson.edu/content/dam/tju/human_research/irb/CITIIRBTrainingInstructionsDec2011.pdf -Full compliment required only once -Refresher course every two years 3. Research Coordinator Course* http://www.citiprogram.org

4. CITI Training: Record of training maintained with OHR(Office of Human Research) Kathleen Avender: 215-503-9820 Training for all study personnel named on the OHR-1 is confirmed, during IRB review process IRB approval letter and stamped materials will not be released until all research personnel have completed required training http://www.jefferson.edu/content/dam/tju/human_research/irb/documents/TrainingList/CurrentTrainingList.pdf

5. CITI Training: Helpful Hints: Use your Jefferson email as login First time training takes several hours; allow adequate time Create your own (e)folder with all completed training documents

6. COI (Conflict of Interest): A conflict of interest exists when someone has an interest that may compromise their ability to remain impartial and objective. Does not necessarily imply wrong doing The conflict lies in the situation, not necessarily in any behavior Examples of COI: Investigator has financial interest that is connected in some way to a clinical trail Investigator’s desire for authorship, based on high enrollment

7. COI (Conflict of Interest): Actual or perceived COI may threaten public support for the research mission of academic institutions Publically available information TJU is a nonprofit/tax-exempt organization: prohibited from engaging in any activity the primary purpose of which is to financially benefit any individual prohibits any corporate income to benefit any individual or group of individuals Federal regulations are in place that require all study personnel to disclose potential sources of conflict 21CFR 54

8. Disclosure of COI: Done annually, via an online system Jefferson Faculty and Employees: https://jefferson.coi-smart.comhttps://jefferson.coi-smart.com sign in with your campus key and password Students or non-TJU employee: JeffCOISmart@jefferson.edu via emailJeffCOISmart@jefferson.edu provide your name, (and campus key if you have one), email address, institution or school you are associated with You will receive an email from the COI-SMART System with instructions to gain access to submit your disclosure. Contact information: Janyce Lingo Phone: (215)503-0758 Email: JeffCOISmart@jefferson.eduJeffCOISmart@jefferson.edu

9. Breaking News! Recent TJU Policy change to ensure compliance with federal Regulations TJU Policy 107.03: research activities sponsored by the PHS (Public Health Service of the U.S. Dept. of Health and Human Services), including the NIH Training: “Investigators must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years” Also when… When the University’s COI policies change in a manner that affect Investigator requirements When an Investigator is new to TJU When the University discovers non-compliance with the COI policy or management plan http://tjuh.jeffersonhospital.org/policy/index.cfm/universitypnp/view/id/11603

10. COI Training: Now available through CITI Training http://www.citiprogram.org Complete the Responsible Conduct of Research (CRC) course Record of COI training maintained with Office of University Counsel Contact information: Janyce Lingo Phone: (215)503-0758

11. Ora.clinical Listserv: Listserv used to disseminate information from the Office of Human Research and Jefferson Clinical Research Institute https://lists.jefferson.edu/mailman/listinfo/ora.clinical

12. Standard Operating Procedures (SOPs) Policies and Procedures: Founded in federal regulations, GCPs and institutional policies General processes; common to all studies Ensure uniformity of performance Tools to manage compliance obligations ensures the entire team understands and meets their regulatory obligations Necessary to complete the circle of quality control Training/Audits/Investigations