• eResearch Regulatory Management Update

    eResearch Regulatory Management version 4.3 has been released. Many of the changes in RM 4.3 are meant to support the U-M Office of Research Flexibility Initiative which seeks to leverage burden...
    Posted On: June 11, 2018
  • Study Teams: What to Know and How to Prepare

    The effective date for the 2018 Federal Policy for the Protection of Human Subjects ("2018 Common Rule") will likely be further delayed until January 21, 2019. This delay gives the U-M IRBs time to:
    Posted On: May 22, 2018
  • Dr. Anna Lok Receives 2018 EASL International Recognition Award

    Congratulations to Dr. Anna Lok, Assistant Dean for Clinical Research, on receiving the 2018 European Association for the Study of the Liver (EASL) International Recognition Award.
    Posted On: May 1, 2018
  • IRBMED New Statement of Practice: Agenda Management Timeline

    Beginning in May 2018, IRBMED committees will implement an Agenda Management Timeline that includes deadlines for submissions that require review at a convened Full Board meeting. The primary goals...
    Posted On: April 27, 2018
  • Revised Specialty Informed Consent Templates

    IRBMED has revised two of its specialty informed consent templates—the template for one-time blood draw and the template for survey-only studies—to reflect some of the new language in the revised...
    Posted On: April 18, 2018
  • CTSO and OnCore Staff Showcase Accomplishments at Onsemble Conference

    Several of members of the Clinical Trials Support Office and our Strategic Partners attended the 25th Annual Forte Onsemble Conference, a biannual event that brings the research community together...
    Posted On: April 10, 2018
  • OnCore Phase II Implementation Pilot at Success!

    The U-M Medical School has made a long-term commitment to improving clinical trials research and the research patient experience. Our clinical trials community identified the need for an integrated...
    Posted On: March 9, 2018
  • Revised Standard Informed Consent Template

    Effective March 9, 2018, IRBMED has revised its standard informed consent template.  The working version containing blue and orange text boxes has been updated with additional instructions and...
    Posted On: March 9, 2018
  • Recap: "Experiencing the Clinical Trials Transformation"

    "Overall, we found that it really HAS made things a lot more transparent!" was one of the first observations made by Peter Higgins, M.D., Ph.D. at a recent Clinical Trials Support Office event. "I...
    Posted On: March 6, 2018
  • Preparing the Next Generation of Clinical Investigators

    A new six-month program at Michigan Medicine, the Clinical Trials Academy, recently kicked off with its first learning session in January.
    Posted On: February 12, 2018