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1Developed by:U-MICTo 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 enrollmentin eResearchDeveloped by:U-MICUniversity of Michigan IRB Collaborative

Enrollment

3Developed by:U-MICmaximum number of subjects to be enrolled

eResearch Regulatory ManagementSection 08 ** Section 03-2 for Cancer Center studiesEnrollment

4Developed by:U-MICscheduled continuing review (SCR) application

eResearch Regulatory ManagementSection 02-2 (SCR)Enrollment

5Developed by:U-MICover-enrollmentviolation of IRB-approved protocolparticularly concerning with research that presents more than minimal risk

under-enrollmentmay result in insufficient dataEnrollment

6Developed by:U-MICU-M standard definition of enrolledconsented and screened,with eligibility verifiedmain application: section 08 (section 03-2 for Cancer Center studies)SCR application: section 02-2

subjects enrolled = number of subjects expectedto complete the studyincludes dropouts (withdrawals)does not include screen failuresEnrollment

7Developed by:U-MICenrollment

applies to studies involving intervention or interaction with individual subjectsdoes not apply to secondary use of samples and/or dataEnrollment

8Developed by:U-MICinclusion and exclusion criteriaage / other demographicshealthcharacteristics

screeningmay or may not involve interaction or interventionmay take place before informed consent(waiver of consent for recruitment)may take place after informed consentEnrollment

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

Enrollment

10Developed by:U-MICprotocol-specific definitions of enrolled

common in multi-site trials with outside sponsorshipmay differ from U-Ms standard definitionEnrollment

11Developed by:U-MICMBECT(Michigan Budget Enrollment Calendar Tool)clinical trialsseparate from eResearchMBECT subject enrollment record for each consented participant

Contact CRAO (the Calendar Review and Analysis Office) for clinical research billing help.Enrollment

12Developed by:U-MICeResearch Release Notes Version 3.2http://www.umich.edu/~eresinfo/errm/rnotes/releasenote_v3.2.html

Enrolled for human subjects studies in eResearchhttp://medicine.umich.edu/medschool/sites/medicine.umich.edu.medschool/files/res_irbmed_EnrollmentDefinition_AdditionalHelp.pdf

CRAOhttp://medicine.umich.edu/medschool/research/office-research/calendar-review-analysis-office/mbectthank you.Lark SpeyerIRBMED13Developed by:U-MIC