临床研究步骤

Help for New 临床研究ers 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. 

像这样, this resource serves to help medical students, 居民, fellows and junior faculty who can benefit from guidance on becoming clinical researchers.

Steps in the 临床研究 Pathway

1. 完整的 CITI training requirements and upload your CV and professional license (if appropriate) to InfoEd.
2. Formulate a written research project (please contact researchacademic@aangny.com for the most current study proposal form) with assistance from one or more of the following resources:
   1. 健康科学图书馆 
   2. researchacademic@aangny.com (Department of 临床研究 and Public Health) 
3. 搜索Creighton’s Master Project Database (coming soon) to ensure that your proposed project does not duplicate a prior or ongoing project.
4. Sponsored Program Administrators, 临床研究 Office within the Department of 临床研究 and Public Health can help identify funding sources, 创建预算, 帮助管理资金. 伸出手去 ResearchAcademic@aangny.com
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 (please contact researchacademic@aangny.com for the most current study proposal form) and return to researchacademic@aangny.com.
      1. Department of 临床研究 and Public Health will critique all projects regardless of who is doing statistical analysis.
      2. Department of 临床研究 and Public Health comments must be satisfactorily resolved before proceeding.
      3. Obtain mentor’s written approval of resulting changes.
   2. If (1) → contact the Department of 临床研究 and Public Health  for feasibility assessment, 协调支持, 知情同意支持, 其他步骤:电子邮件 researchacademic@aangny.com.
   3. If (2) → determine where data is located and if it is obtainable. May require data request form at CHI website. The Department of 临床研究 and Public Health can help: email researchacademic@aangny.com.
   4. If (3) and using ≥3 patients → you must submit to the IRB. Department of 临床研究 and Public Health can help: contact researchacademic@aangny.com.
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@aangny.com and the Department of 临床研究 and Public Health 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 – barbarabittner@aangny.com.