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Mayo Clinic Center for Translational Science Activities Regulatory Affairs Update

Mayo Clinic Center for Translational Science Activities Regulatory Affairs Update. Mayo Clinic CTSA Service Center. Previously established consulting center to assist Mayo Clinic investigators with research needs (study design, Biostats, etc)

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Mayo Clinic Center for Translational Science Activities Regulatory Affairs Update

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  1. Mayo Clinic Center for Translational Science Activities Regulatory Affairs Update

  2. Mayo Clinic CTSA Service Center • Previously established consulting center to assist Mayo Clinic investigators with research needs (study design, Biostats, etc) • Additional support areas added or integrated with the CTSA award (ethics, research subject advocacy, regulatory affairs)

  3. Regulatory Affairs Office • Office established in Summer 2007 under the Mayo Clinic CTSA Service Center Model • Current staff • Medical Director • Mike Joyner, MD • Manager • Karen Hartman, RN, MSN

  4. Regulatory Affairs Office • Primary aims of the office: • Creating centralized office for monitoring and tracking sponsor-investigator INDs and IDEs • Assisting investigators with IND or IDE applications, reports, and other FDA correspondence • Establishing electronic IND/IDE database system

  5. Implementation Barriers • Large institution • Departments/centers have their own in-house systems and procedures • Communication • Change – difficult for some to accept • Other operational support

  6. Implementation Success • Regulatory Affairs office concept well received thus far • Increased collaboration with research staff in multiple departments • Decreased duplication of efforts and procedures in multiple areas

  7. Future Considerations • Novel Methods of Consent • DNA Issues

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