Protocol Development

The Translational Research Institute (TRI) assists in developing high quality research protocols. Study documents are reviewed to ensure the presence of basic elements and the coherence of objectives, design and methodology. Depending on the scope and complexity of the research, a project team comprised of relevant subject matter experts (biostatistician, research pharmacist, regulatory affairs professionals, etc.) may be formed to evaluate the study and provide constructive feedback on moving the project forward. A variety of tools and customizable templates are provided below to help investigators get started.

Services

  • Reviewing and editing protocols and supporting documents prior to submission to Institutional Review Board (IRB) and other regulatory oversight bodies
  • Provision of custom templates for research protocols, informed consent forms and other study documents
  • Coordinating efforts of multi-disciplinary project teams during protocol development

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Protocol Development Tools and Templates