1 Developed by: U-MIC 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 Developed by: U-MIC University of Michigan IRB Collaborative

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

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

Enrollment 5 Developed by: U-MIC 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 6 Developed by: U-MIC U-M standard definition of enrolled 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 expected to complete the study includes dropouts (withdrawals) does not include screen failures

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

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

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

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

Enrollment 11 Developed by: U-MIC 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 12 Developed by: U-MIC eResearch Release Notes Version Enrolled for human subjects studies in eResearch res_irbmed_EnrollmentDefinition_AdditionalHelp.pdf CRAO analysis-office/mbect

THANK YOU. Lark Speyer IRBMED 13 Developed by: U-MIC