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Effective Enrollment Strategies in Research Management

This presentation covers key enrollment strategies in research management, including regulatory compliance, subject eligibility, and study protocols. Learn how to navigate enrollment challenges effectively.

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Effective Enrollment Strategies in Research Management

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  1. To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC

  2. Human subjects enrollmentin eResearch Developed by: U-MIC University of Michigan IRB Collaborative

  3. maximum number of subjects to be enrolled Enrollment eResearch Regulatory ManagementSection 08 * * Section 03-2 for Cancer Center studies Developed by: U-MIC

  4. scheduled continuing review (SCR) application Enrollment eResearch Regulatory ManagementSection 02-2 (SCR) Developed by: U-MIC

  5. over-enrollment • violation of IRB-approved protocol • particularly concerning with research that presents more than minimal risk • under-enrollment • may result in insufficient data Enrollment Developed by: U-MIC

  6. U-M standard definition of enrolled Enrollment consented and screened,with eligibility verified • main application: section 08 (section 03-2 for Cancer Center studies) • SCR application: section 02-2 • subjects enrolled = number of subjects expectedto complete the study • includes dropouts (withdrawals) • does not include screen failures Developed by: U-MIC

  7. enrollment • applies to studies involving intervention or interaction with individual subjects • does not apply to secondary use of samples and/or data Enrollment Developed by: U-MIC

  8. inclusion and exclusion criteria • age / other demographics • health • characteristics • screening • may or may not involve interaction or intervention • may take place before informed consent(waiver of consent for recruitment) • may take place after informed consent Enrollment Developed by: U-MIC

  9. At SCR, report individuals determined ineligible as screen failures in eResearch section 02-2.2. Enrollment Developed by: U-MIC

  10. protocol-specific definitions of enrolled • common in multi-site trials with outside sponsorship • may differ from U-M’s standard definition Enrollment Developed by: U-MIC

  11. MBECT(Michigan Budget Enrollment Calendar Tool) • clinical trials • separate from eResearch • MBECT subject enrollment record for each consented participant • Contact CRAO (the Calendar Review and Analysis Office) for clinical research billing help. Enrollment Developed by: U-MIC

  12. Enrollment • eResearch Release Notes Version 3.2 • http://www.umich.edu/~eresinfo/errm/rnotes/releasenote_v3.2.html • Enrolledfor human subjects studies in eResearch • http://medicine.umich.edu/medschool/sites/medicine.umich.edu.medschool/files/res_irbmed_EnrollmentDefinition_AdditionalHelp.pdf • CRAO • http://medicine.umich.edu/medschool/research/office-research/calendar-review-analysis-office/mbect Developed by: U-MIC

  13. Lark Speyer IRBMED thank you. Developed by: U-MIC

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