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Human subjects enrollment in eResearch

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 . Human subjects enrollment in eResearch. maximum number of subjects to be enrolled. Enrollment.

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Human subjects enrollment in eResearch

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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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