Screening and Enrollment of Subjects Standard Practice Guideline


It is essential for research teams to understand the importance of appropriately recruiting, screening, and enrolling study subjects for clinical trial research. To effectively manage these processes, the following recommendations should be considered:

  • Develop defined tracking mechanisms for identification of clinical trial subjects which limit the possibility of repeat requests for screening (this can also state the number of attempts made to recruit a subject)

  • Utilize documentation flow sheets or source to support appropriately enrolled, eligible subjects

  • Obtain IRB approval for advertisements and other necessary recruitment materials that will be provided to potential study subjects

  • Maintain IRB and FDA language tracking, as necessary

In addition, some research teams recommend categorizing the reasons that an individual chooses not to participate or is ineligible. This information could help the research team evaluate how enrollment is progressing and whether there are any issues or disincentives for participation.




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