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System-Wide IRB Compliance Training and Assessment Initiative

IU Health system aims to complete training for identified sites and establish streamlined clinical trials research approach. Current and next steps outlined for achieving compliance. Contact Edye Taylor for further information.

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System-Wide IRB Compliance Training and Assessment Initiative

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  1. IU Health System-wide IRB Edye Taylor, JD, MA, CIP Senior Compliance Project Manager Clinical Research Compliance OfficeIU Office of Research Compliance

  2. Goals of System-wide IRB: • Short-term • Complete the final phase (training) for the first four identified sites, and the assessment process of the fifth and final identified site • Long-term • Establish a streamlined approach to recruit and perform clinical trials research at IU Health facilities in coordination with IU Health Physicians and Indiana University.

  3. Current Status • Completed for all IUH Bloomington, Ball, Arnett and Goshen: • Site visit followed by full evaluation of site by CRCO • Prepare report of findings and recommendations for each location based on evaluation at each location • Determine individualized needs/requirements for training at each location • In Progress at these sites (examples of Training): • Executing IRB Authorization Agreements • Instituting/Revising COI Policies • Creating CITI accounts • Revisions of SOPs and forms • IND/IDE and vulnerable population training

  4. Next Steps • Completing the Assessment Process: • La Porte – special case • Continuing proposed plan for each site to move forward (Phases): • V -Training • VI –Maintenance • Looking Ahead: • Only one application and approval would be needed to conduct multi-site research within IU and IU Health locations • First protocol has been approved – Cook Trial

  5. Current Process:New Studies • Complete IRB Authorization Agreement with IU IRB • Outside institution defers to IU IRB review and approval • IU Health Ball, Bloomington, Goshen and Arnett have this in place • Ensure all co-investigators from outside sites are listed on IRB application • Co-investigators required to: • Complete IU Conflict of Interest Disclosure Form • Complete CITI modules or provide verification of education completion via the outside institution

  6. Current Process:Existing Studies • Add co-investigators to existing IU-IRB/IUH Statewide approved study • Co-Investigator Update • Complete IU Conflict of Interest Disclosure Form • Co-investigator(s) complete CITI modules • For Key Personnel: • Submit update via Amendment or Continuing Review form, and an Investigator List form for approval • For Non-Key Personnel: • Submit update via Investigator List form and no need for approval • Defining Personnel: • http://www.researchadmin.iu.edu/HumanSubjects/hsdocs/IRB_Updates_February_2012_PPT.pdf

  7. Current Process:Existing Studies • Add co-investigators and site to existing IU-IRB/IUH Statewide study • Minor Amendment • Complete Amendment Form to indicate minor amendment and co-investigator addition(s) • Complete IU Conflict of Interest Disclosure Form • Co-investigator(s) complete CITI modules

  8. Questions? Contact: Edye Taylor tayloret@iu.edu 278.5926

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