Clinical Research Development and Consultation

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Clinical research is a complex undertaking. Projects must be designed and planned accordingly, with a thoughtful approach and plenty of input from experienced researchers. In addition, studies are subject to any number of reporting and oversight requirements, including registration and multi-site Institutional Review Board approvals.  We are here to help investigators develop their research projects and navigate the appropriate approvals and reporting requirements.  

The Clinical Research Development Team is available to discuss projects that are in development, ready to implement, or experiencing challenges. For early-career investigators, OCTRI Design Studios are a great place to get feedback as you develop grant proposals. If your study needs a data and safety monitoring plan, OCTRI staff can help. And if you’re confronting barriers in getting a multi-site clinical trial or research project off the ground, the Trial Innovation Network can be an invaluable resource. 

Learn more about these resources below.  

The Clinical Research Development Team is available to meet with investigators to discuss projects that are in development, ready to implement or are experiencing difficulties and need assistance to identify strategies to overcome barriers. This meeting involves experienced clinical research staff and faculty and can help investigators identify operational best practices, find tools and connections that may help to streamline their project and provide overall advice to help guide the project. 

The Research Navigator can give you more information about working — and scheduling a meeting—with this team. Check out the video below for a quick overview of what it’s like to work with the Clinical Research Development Team.

OCTRI Design Studios are set up to maximize the success of OHSU’s early-career investigators by providing feedback on career development grant proposals or on first R grant proposals as they are being developed. Design Studios invite members of the senior OHSU research community, mentors, multidisciplinary faculty and interested partners to listen to a short presentation of your proposal, ask questions, and provide feedback on your specific aims, research methodology and career development plans.  

To schedule a Design Studio or to learn more about this opportunity, please contact Melissa Mudd

Conducting research involving human subjects requires review and approval by the Institutional Review Board and/or other review committees, including sometimes the U.S. Food & Drug Administration, as mandated by Federal regulations and OHSU policies and procedures.  Investigators do not have to become regulatory experts to successfully fulfill compliance requirements necessary to get their study started.  OCTRI has resources available to guide investigators through the process.

Data and safety monitoring

A data and safety monitoring plan describes how the study will be overseen for subject safety and data integrity. Specific activities in a data and safety monitoring plan are determined by the complexity and risk of the study. OCTRI staff can draft or review these plans for grants. 

A data and safety monitoring board is a group of individuals charged with oversight of the safety of subjects and data integrity in a study. OCTRI staff members can help investigators determine if their study needs a data and safety monitoring board and assist in development of a charter.  

Investigational New Drug and Investigational Device Exemption consultations

When studies involve drugs or devices not approved by the U.S. Food & Drug Administration (FDA), or drugs or devices used for purposes not approved by the FDA which pose an increased risk, investigators are required to get clearance from the FDA prior to enrolling subjects in their study. OCTRI compliance experts have experience in determining whether a drug or device requires an Investigational New Drug (IND) or Investigational Device Exemption (IDE) and can consult on the application process. 

OCTRI can help investigators determine if they need an I Investigational New Drug exemption and advise you in requesting a determination from the Institutional Review Board or the FDA. If an exemption is required, OCTRI can advise investigators on what information is required. 

OCTRI staff will help investigators determine if they need to apply for an investigational device exemption from the FDA and, if so, can advise on what information is required for the application.

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The Clinical and Translational Science Award program has established the Trial Innovation Network to assist investigators planning and conducting multi-site research. This network provides resources and infrastructure, addresses barriers faced by multi-site clinical trials and research projects, and helps investigators conduct trials faster and with greater cost-efficiency. In addition, the network serves as a national laboratory to help understand and innovate the process of conducting clinical trials.

Primary Components of the Trial Innovation Network 

  • Single IRB review using SMART IRB platform 

  • Master contracting agreements 

  • Expert consultation on study design 

  • Expert consultation on feasibility 

  • Recruitment planning and tools 

  • Patient engagement  

  • Identification of ideal sites  

  • Harmonization of processes across sites  

OCTRI's role in the Trial Innovation Network

All Clinical and Translational Science Award sites, including OCTRI, are designated as local “hubs” of the Trial Innovation Network. As a hub, OCTRI's research team helps OHSU investigators design multi-center research and advises investigators on potential national resources available through the network. Furthermore, we guide investigators in the application process, leveraging our experience and knowledge of the local environment to coordinate any network activities at OHSU as appropriate.

OCTRI's Clinical Research Development Team for the Trial Innovation Network is led by Cynthia Morris, Ph.D., M.P.H. If you have questions or would like to set up a time to discuss your research project, please contact OCTRI's Trial Innovation Network project manager, Kitt Swartz.    

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