Clinical Research Development and Consultation

Clinical research is a complex undertaking. Projects must be thoughtfully designed and are subject to any number of reporting and oversight requirements.  OCTRI is here to help investigators develop their research projects and navigate the appropriate approvals and reporting requirements. 

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Clinical Research Development Team

Meet with experienced investigators to identify best practices and overcome barriers for your research project

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OCTRI Design Studio

Maximize the success of your career development grant proposal or first R grant proposal with expert feedback from a Design Studio session

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OCTRI Research Navigator

Your one stop shop for questions about OCTRI services, study implementation, and research operations at OHSU

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Clinical Research Development Team

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The Clinical Research Development Team is available to meet with investigators to discuss projects that are in development, ready to implement, or that are experiencing difficulties and need assistance to identify strategies to overcome barriers.

This meeting involves experienced clinical research staff and faculty who can help investigators identify operational best practices, find tools, and connections that may help to streamline their project and who can provide overall advice to help guide the project.

Check out the video for a quick overview of what it’s like to work with the Clinical Research Development Team. Email the OCTRI Navigator to schedule a meeting: 

Regulatory consults

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Conducting research involving human subjects requires review and approval by the Institutional Review Board and potentially other review committees, including sometimes the U.S. Food and Drug Administration.  Investigators do not need 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.

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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.  

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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.

Trial Innovation Network

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The Trial Innovation Network assists investigators in planning and conducting multi-site research. This network provides resources and infrastructure to address 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.

  • 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  

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.

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.