Subject Enrollment Policy Reminder: For Clinical Researchers and Study Teams

This is a reminder of the University’s policy for clinical research subject enrollment. We track all subjects involved in clinical research protocols that test a drug, device or biologic and/or involve procedures, lab tests, and/or interventions on a patient. According to the policy, a principal investigator (or their designee) must submit a research subject enrollment/disenrollment form within 24 hours of subject consent or disenrollment from a study (for any reason other than the end of the study). You can submit the form on the Clinical Research Initiation Services (CRIS) website or by entering the subject’s enrollment status in Velos. For more information, visit the enrollment policy or browse the FAQs.

Notification of the CRIS office or the Jackson Health System Clinical Trials Office (JHS-CTO) of subject enrollment at UM or JHS does not relieve investigators of their responsibility to notify the Institutional Review Board (IRB) of subject enrollment at the time of the protocol’s continuing report submission per IRB policy. If subjects are enrolled at or participate in studies at a JHS facility, investigators are also responsible for notifying the JHS-CTO within 24 hours, as required per JHS policy.

More information:

· CRIS subject enrollment policy: http://velostest.med.miami.edu/ORIM/html/Training/documents/ClinResSubjectEnrollmentPolicy11%2008.pdf

· Velos login: http://velos.miami.edu/

· FAQs on the CRIS subject enrollment policy: http://www.med.miami.edu/cris/documents/Enrollment%20Policy%20FAQs%20final.pdf

· IRB policy: https://eprost.med.miami.edu/Eprost/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5BOID%5B46762A4B6B546A479CEF47FA0B39395B%5D%5D

· JHS policy: http://www.med.miami.edu/cris/documents%5CJackson%20Subject%20Enrollment%20Notification%20Policy.pdf