Welcome to the Homepage for the Clinical Research Initiation Services Office (CRIS)

Regarding ALL New projects, amendments and extensions
September 02, 2009 - For all new projects, amendments and extensions submitted to CRIS, the study team will be required to include a completed Financial/Proprietary Interest Declaration Form (“FID”) signed by the Principal Investigator. If a Financial or Proprietary Interest that exceeds the threshold is disclosed in the FID, the project will be referred to the Office of Research to determine if a management plan will be required. The Office of Research review must be conducted prior to CRIS approving the project and signing any contract related to the project. CRIS will not assign the project to a team member for review until it receives the signed FID.

The FID may be found at: https://www6.miami.edu/research/coi/fid.pdf. More information on Conflict of Interest may be found at: http://www6.miami.edu/UMH/CDA/UMH_Main/1,1770,2425-1;66337-3,00.html

Attention Clinical Researchers and Study Teams: Revised Subject Enrollment and Tracking Policy in Effect
February 04, 2009 - The Clinical Research Subject Enrollment policy ensures that the University tracks all clinical research 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.  This is a reminder that the University recently revised this policy.  The principal investigator (or designee) is required to notify the office of Clinical Research Revenue Cycle (CRRC) within 24 hours of consenting a patient to participate and upon dis-enrollment (for any reason) from a study that meets this criterion.

What do I need to do?
Within 24 hours of subject consent or subject dis-enrollment from a study (for any reason other than end of study treatment), principal investigator or designee will submit the Research Subject Enrollment/Dis-Enrollment Form to the CRRC by either (i) submitting a Research Subject Enrollment/Dis-Enrollment form available at www.med.miami.edu/cris or (ii) entering Subject Enrollment/Dis-Enrollment and maintaining patient status information in Velos at https://velos.med.miami.edu if the study is built in Velos.

Links to Policy Language and FAQs:
Enrollment Policy
FAQs

  Clinical Research Revenue Cycle (CRRC) and Clinical Research Initiation Services (CRIS) Consolidate
November 10, 2008 - In an effort to better serve the research community and conserve resources, the Office of Research, led by Dr. Richard Bookman, has consolidated the Clinical Research Revenue Cycle (CRRC) into the Clinical Research Initiation Services (CRIS) group. The expanded service-oriented office, led by Suzanne Liv Page, JD now provides all of the central administrative functions that support clinical research involving human subjects, including budgeting,contracting, research billing compliance, and enhanced revenue recognition. The CRIS group is separate from the HSRO, which handles issues germane to human subjects protection, and enables IRB review.

All researchers conducting studies with human subjects are required to coordinate each project with CRIS. Please note that investigators must submit subject enrollment forms to the office within 24 hours of enrolling a subject.

For more information, visit www.med.miami.edu/cris or contact Suzanne Liv Page, JD at spage3@med.mami.edu , 305.243.7704.

Update Session on Velos eResearch Deployment with Demonstration
May 09, 2008 - Late last year UM acquired the Velos eResearch clinical research management system as a central resource for clinical research studies. This deployment is part of three major initiatives in the Office of Research to improve our ability to initiate and manage clinical research efforts and simplify as many of the supporting processes as possible. On May 21st, the Office of Research Information Management will host an information session.This session will give an update on Velos deployment status and rollout, process transformation, overview of functionality with a brief demonstration, and make the project team available to answer questions. This is a great opportunity for investigators, departments and study coordinators to learn more about Velos and how it is and will be used. More information on Velos can be found at: http://med.miami.edu/orim.

CRIS office has moved to a new location
April 23, 2008– The CRIS office has moved from the Sewell Building on the UM Medical Campus to the Dominion Towers (10th Floor). Their mailing address is 1400 NW 10th Ave., Miami, FL. 33136. If you have any questions please contact their general phone number (305-243-7704)

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