A Road Map to Clinical Research at Jefferson

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

CITI Training:Collaborative Institutional Training Initiative at the University of Miamihttp://www.jefferson.edu/content/dam/tju/human_research/irb/CITIIRBTrainingInstructionsDec2011.pdf

1.Basic Human Subject Protection (HIPPA incl.)2.Good Clinical Practice (GCP)

-Full compliment required only once-Refresher course every two years

3. Research Coordinator Course*

http://www.citiprogram.org

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

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

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 behaviorExamples 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

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

Disclosure of COI:Done annually, via an online system

• Jefferson Faculty and Employees: https://jefferson.coi-smart.com• sign in with your campus key and password

• Students or non-TJU employee: JeffCOISmart@jefferson.edu via email• 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 LingoPhone: (215)503-0758Email: JeffCOISmart@jefferson.edu

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 planhttp://tjuh.jeffersonhospital.org/policy/index.cfm/universitypnp/view/id/11603

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 CounselContact information: Janyce LingoPhone: (215)503-0758

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

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