• Review Process

    The Clinical Translational Research Center project coordinator reviews the protocol for completeness and schedules it for review in the next monthly CTRC Scientific Advisory Committee meeting at Cincinnati Children’s Hospital Medical Center.

    All members of the committee are expected to review each protocol, but two members are appointed by the SAC chairman to serve as scientific reviewers, who make a detailed scientific assessment and specific recommendations with respect to approval, disapproval or modifications. In addition, there is a biostatistical reviewer and a safety reviewer. The needs for special resources (such as nursing, dietary and the core services) are considered in terms of overall center resource capabilities.

    The biostatistician on the CTRC Scientific Advisory Committee reviews the protocol to assess the appropriateness of the statistical analysis, including sample size calculations and methods of data analysis; and evaluates adequacy of the data management plan in collaboration with the informatics manager. The RSA or designee reviews the protocol, consent documents, and data safety and monitoring plan for safe, ethical conduct and regulatory compliance. If serious criticisms are encountered, the protocol is returned to the investigator for modification before re-review by the full committee.

    Each approved protocol is scored on scientific merit and priority for resource use.
    Once the protocol is approved, the investigator is directed in the approval letter to contact the CTRC research nurses to begin the implementation process.

    Meeting Dates And Deadlines

    Submission Dates

    Meeting Dates

    December 26, 2013January 16, 2014
    January 28, 2014February 20, 2014
    February 25, 2014March 20, 2014
    March 25, 2014April 17, 2014
    April 22, 2014May 15, 2014
    May 27, 2014June 19, 2014
    June 24, 2014July 17, 2014
    July 29, 2014August 21, 2014
    August 26, 2014September 18, 2014
    September 23, 2014October 16, 2014
    October 28, 2014November 20, 2014
    November 25, 2014December 18, 2014

    Administrative approval (prior to the meeting) will only be administered in special circumstances.

    How to Reach Us

    For more information, contact Amy Hartkemeyer, business director, 513-636-4273, amy.hartkemeyer@cchmc.org.