Clinical Research Steps

Help for New Clinical Researchers Navigating the Process

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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. Complete CITI training requirements and upload your CV and professional license (if appropriate) to InfoEd.
2. Formulate a written research project with assistance from one or more of the following resources:
   1. Health Science Library 
   2. researchacademic@creighton.edu (Clinical Research Office) 
3. Search Creighton’s Master Project Database (coming soon) to ensure that your proposed project does not duplicate a prior or ongoing project.
4. Consider potential funding sources.
   1. Sponsored Programs Administration can help identify funding sources.
   2. Clinical Research Office (CRO) can help manage funds. Email researchacademic@creighton.edu.
5. 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 and return to researchacademic@creighton.edu.
      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 researchacademic@creighton.edu.
   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 researchacademic@creighton.edu.
   4. If (3) and using ≥3 patients → you must submit to the IRB. CRO can help: contact researchacademic@creighton.edu.
6. Present proposal to the appropriate department/division research committee.
   1. Make required changes based on committee’s comments.
7. Send revised proposal to the researchacademic@creighton.edu and the CRO will complete the IRB submission in InfoEd.
8. All data should be collected and stored in the Creighton DFS. A folder will be created for each individual project, and all personnel associated with this study will have access to this folder.
9. Once IRB approval is received, begin collecting data per protocol.
10. Notify the statistician of completion of data collection.
11. Plan to 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 in Sponsored Programs Barb Bittner – BarbBittner@creighton.edu.