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
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CITI Training:
Collaborative Institutional Training Initiative at the
University of Miami
http://www.jefferson.edu/content/dam/tju/human_research/irb/CITIIRBTrainingInstructionsDec2011.pdf
1.Human Subject Research (HIPPA incl.) [@ 8 modules]
2.Good Clinical Practice (GCP) [@ 13 modules]
-Full compliment required only once
-Refresher course every two years
3. COI
4. Optional Courses: Clinical Research Coordinator (CRC)
and Responsible Conduct of Research (Biomedical and
Administrators)
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 behavior
• Examples of COI:
• Investigator has financial interest that is connected in
some way to a clinical trial
• Effort /time required to perform research
responsibilities conflicts with ability to perform primary
job duties
COI (Conflict of Interest):
Federal regulations are in place that require all study
personnel to disclose potential sources of conflict
21CFR 54
TJU is a nonprofit/tax-exempt organization:
• prohibited from engaging in any activity that is designed to
financially benefit an individual
• prohibits any corporate income to benefit an individual or group
of individuals
Disclosed COI information is publically available
• Actual or perceived COI may threaten public support for the
research mission of academic institutions
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 Lingo
Phone: (215)503-0758
Email: JeffCOISmart@jefferson.edu
Recent TJU COI Policy change to ensure
compliance with federal Regulations:
TJU Policy 107.03:
“Investigators must complete training prior to engaging in
research… 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
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
Ora.clinical Email Listserv:
Email listserv used to disseminate information
and educational opportunities from the Office
of Human Research and Jefferson Clinical
Research Institute
https://lists.jefferson.edu/mailman/listinfo/ora.clinical
* You must sign yourself up and assign a password
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
Questions?