Clinical Research Steps

Clinical Research Steps

Help for New Clinical Researchers Navigating the Process

Clinical research – like the practice of internal medicine in general – requires an orderly and systematic approach to increase the likelihood of success. However, such an approach may not be intuitive, resulting in unnecessary roadblocks. Most successful researchers either had intense mentorship while navigating the research pathway OR they succeeded only after numerous failures. 

As such, this resource serves to help medical students, residents, fellows and junior faculty who can benefit from guidance on becoming clinical researchers.

Steps in the Clinical Research Pathway

  1. Enroll in IRBNet, complete CITI training requirements, and upload your CV to IRBNet.
  2. Ascertain whether your project is QI or clinical research with this quiz.
  3. Formulate a written research project, with assistance from one or more of the following resources:
    1. Health Science Library
    2. Clinical Research Office
    3. Research Compliance Policies
  4. Search Creighton’s Master Project Database to ensure that your proposed project does not duplicate a prior or ongoing project.
  5. Consider potential funding sources.
    1. Sponsored Programs Administration can help identify funding sources.
    2. Clinical Research Office (CRO) can help manage funds. Email Caroline Nubel.
  6. Is project design: (1) randomized-controlled or prospective; (2) retrospective; or (3) case report or case series?
    1. If (1) or (2) → complete the Study Proposal Form (.docx) and return to Ryan Walters.
      1. CRO will critique all projects regardless of who is doing statistical analysis.
      2. CRO comments must be satisfactorily resolved before proceeding.
      3. Obtain mentor’s written approval of resulting changes.
    2. If (1) → contact CRO for feasibility assessment, coordinator support, informed consent support, additional steps: email Caroline Nubel or Sandy Byers.
    3. If (2) → determine where data is located and if it is obtainable. May require data request form at CHI website. CRO can help: email Marge Cox.
    4. If (3) and using ≥3 patients → you must submit to the IRB. CRO can help: contact Caroline Nubel.
  7. Present proposal to the appropriate department/division research committee.
    1. Make required changes based on committee’s comments.
  8. Once approved, submit proposed project to IRBNet. If you have problems with IRBNet, email Caroline Nubel.
  9. Register your project in the Master Project Database by emailing Marge Cox.
  10. Collect data per protocol.
  11. If previously agreed upon – submit data to CRO (Ryan Walters) or Sponsored Programs for analysis.
  12. Present at a national meeting and/or publish results in a peer-reviewed journal.
    1. If English is not your native language, consider input from the medical editor.