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CCTS Regulatory Knowledge and Support

Summary:

Navigating the federal and local regulatory landscape can be time consuming and confusing. The goal of the regulatory knowledge and support services is to advise research studies in navigating the requirements for federal and local regulations. In order to make that goal a possibility, research teams are encouraged to request regulatory consultation early in the planning and design stages of their studies.
The CCTS Regulatory Knowledge and Support Service provides expertise in revealing and resolving such issues that are particular to any one study. The result is to create a robust environment for human subject research that not only meets the applicable rules and regulations, but promotes the conscientious conduct of these endeavors.

Affiliations:

People:

    Resources:

    Services

    • Consent Document Preparation ( Service )

      In addition to providing consent process and document support, a library of template language for various study procedures and their respective risks has been created for access and use by the research community.

    • Data & Safety Monitoring ( Service )

      Data and safety monitoring plans help outline processes that promote safe study conduct.

      Consultation for developing and drafting Data Safety and Monitoring Plans (DSMP), as well as establishing and operating Data and Safety Monitoring Boards (DSMB), is available through CCTS Regulatory Knowledge & Support Service.

      DSM templates may be accessed and modified to develop a study specific plan and/or a DSMB Charter.

    • Data and Safety Monitoring Boards (DSMB) ( Support service )

      Data and Safety Monitoring Boards (DSMB), assistance with establishing and operating DSMBs. Consultation is available for risk assessment and setup.

    • Data Safety Monitoring Plans (DSMP) ( Support service )

      Data Safety Monitoring Plans (DSMP) DSMP help outline processes that promote safe study conduct. Consultation is available for developing and drafting DSMPs.

    • IND/IDE submission support ( Support service )

      IND/IDE submission support in collaboration with the OSU Drug Development Institute and Nationwide Children’s Hospital’s Drug and Device Development Services, can help research teams navigate these potentially complex processes.

    • Independent Study Safety Monitoring ( Support service )

      The independent study safety monitoring is routinely used for moderate to high risk procedures/trials or trials involving vulnerable populations charged with reviewing study data for data quality and integrity, adherence to the protocol, adherence to the DSMP, participant safety, study conduct and progress.

    • Informed Consent ( Support service )

      Informed Consent: Support for drafting, revising, and finalizing consent/electronic consent documents. In addition to providing consent/electronic consent process and document support, a library of template language for various study procedures and their respective risks can be found at: go.osu.edu/ccts-consent

    • Investigational new Drug or Device Exemption Support ( Service )

      Clinical Trials for drugs being developed for initial use in humans as well as for FDA approved drugs but being investigated for additional use(s) require an Investigational New Drug Approval (IND) from the FDA prior to commencing, and which is required for IRB submission and approval for Ohio State and for Nationwide Children’s Hospital .

      For clinical trials involving marketed drug(s) for alternative use an IND Exemption may be an acceptable alternative. The CCTS, in collaboration with the OSU Drug Development Institute and Nationwide Children’s Hospital’s Drug and Device Development Services, can help research teams navigate these potentially complex processes.

    • IRB submission review ( Support service )

      IRB submission review (single and multi-center trials) Regulatory Knowledge and Support consultation may be able to shorten the time to approval with its experience and particular regulatory and ethics perspective. Clinical research coordinators and investigators can request a consult for BUCK-IRB submission training and associated concerns. This service is complementary to the assistance provided by the University’s Office of Responsible Research Practices (ORRP) and to the University’s overall Human Research Protection Program.

    • IRB/Grant Submission Support ( Service )

      The Institutional Review Board (IRB) review process is often times perceived as the primary rate-limiting step to conducting clinical and translational research. Regulatory Knowledge and Support (RKS) consultation may be able to shorten the time to approval with its experience and particular regulatory and ethics perspective.

      This service is complementary to the assistance provided by the University’s Office of Responsible Research Practices (ORRP) and to the University’s overall Human Research Protection Program.

    • MultiCenter IRB Review ( Service )

      The Ohio State University has an agreement with Western IRB for review of industry initiated and sponsored clinical trials. Additionally, an Institutional Review Board (IRB) reciprocity agreement exists between the University and Nationwide Children’s Hospital.

      The CCTS, in collaboration with the OSU ORRP and the eight institutions that compose the three CTSA sites in Ohio, has executed an agreement to allow one IRB to serve as the IRB of Record for multi-center clinical research studies involving these CTSA-affiliated institutions. The participating institutions include The Ohio State University, Nationwide Children's Hospital, University of Cincinnati, Cincinnati Children's Hospital Medical Center, Case Western Reserve University, University Hospitals- Cleveland, MetroHealth, and the Cleveland Clinic Foundation.

      The “Reliant IRB” model is being pursued by the CCTS in collaboration with ORRP and other CTSA site partners to expand this model to other collaborative research networks; both regionally and nationally. The goal is to improve efficiencies in the IRB review and study implementation processes without compromising the regulatory and ethical environments that exist within any institution.

    • Protocol Consultation ( Support service )

      Protocol Consultation: Beyond the scientific background and procedures of a protocol, there are regulatory and ethical issues to be aware. These domains are the expertise and the primary perspective provided by Regulatory Knowledge and Support, and may have operational implications that pertain to inclusion/exclusion criteria, identification and recruitment of human subjects, the consent process and document, and study monitoring.

    • Protocol Review/Consultation ( Service )

      A Principal Investigator may be the primary expert in knowing the scientific background and procedures of a protocol; however, there are also regulatory and ethical issues to be aware.

      These domains are the expertise and the primary perspective provided by Regulatory Knowledge and Support, and may have operational implications that pertain to inclusion/exclusion criteria, identification and recruitment of human subjects, the consent process and document, and study monitoring.

    • Regulatory Knowledge and Support Education ( Training service )

      Regulatory Knowledge and Support Education
      o Regulatory Knowledge and Support Seminar Series
      o NIH Bioethics seminar series
      o FDA conference

    • Research Subject Advocate ( Service )

      In 2001 the National Institutes of Health (NIH) formally implemented a Research Subject Advocacy (RSA) program through its network of general clinical research centers.

      The RSA program at Ohio State exists for all studies that utilize the services of the Clinical Research Center. Research Subject Advocates are also available upon request for consultation or to serve in such capacity at the discretion of either an OSU IRB, the study sponsor, or the Principal Investigator of a study.

      The Senate Advisory Committee for Human Research Protection recommends the use of an independent party (e.g. RSA) during the process of consent for high risk studies, such as those that involve gene transfer.


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    Last updated: 2021-03-22T12:56:01.567-04:00

    Copyright © 2016 by the President and Fellows of Harvard College
    The eagle-i Consortium is supported by NIH Grant #5U24RR029825-02 / Copyright 2016