Dear UM Research Community,
In order to strategically enhance the University of Miami’s ability to meet increasing institutional reporting requirements for research, a new policy is being implemented, Enrollment Tracking Using REDCap. This policy, jointly sponsored by the University of Miami (UM) Vice Provost for Research and Scholarship (VPRS) and the Miller School of Medicine Executive Dean for Research, requires that study teams use an institutionally supported platform to track participant accruals to human subjects research. Implementation will occur in a phased approach with significant institutional support to ensure there is minimal burden on study team members.
Policy Summary
Effective February 1, 2023, all new human subject research protocols and/or protocol modifications must be registered and tracked in either:
- Velos – Required for protocols requiring items or services that could potentially generate a charge in our billing systems, no matter the funding source, or
- REDCap – Required for all interventional non-treatment studies lacking any services or protocol events that are capable of generating a clinical charge; and all non-interventional studies
By doing so, we maximize data safety, an ongoing priority for NIH and other funding agencies, as well as the ability to effectively capture the scope of clinical research occurring across UM.
Associated System Updates
New questions will be in the IRB10 system on February 16, 2023, to determine whether a study team needs to use Velos or REDCap to track participant accruals. In both instances, teams will be offered institutional support, including the automated creation of a Velos or REDCap project for the study to facilitate consistent enterprise-wide reporting.
Workflow for Studies Requiring REDCap
As of Monday, February 20, 2023, when an IRB protocol is submitted for IRB review, an automatic notification will be sent to the Principal Investigator, PI Proxies, Primary Contacts, and Research Coordinators/Assistants for protocols identified as needing to use REDCap to track participant accruals. Once the IRB Pre-Review is complete, the study team will receive a link to the REDCap project created specifically for their study. The project will facilitate tracking accruals of study participants, including basic socio-demographic characteristics, that are critical for accurately representing the breadth and diversity of the University’s human subjects research portfolio.
Overview Video of Step-by-Step Process
Informational Sessions and Training
There will a virtual town hall on Monday, March 13, 2023, from 5:00pm – 5:45pm to answer questions related to the policy and the plan for implementation. Please register in advance for the Enrollment Tracking Policy Town Hall meeting. Anyone needing additional support can: (1) email TrackingQuestions@miami.edu; (2) review the FAQs document; and (3) request a more focused training for their study team, Department/Division, and/or School/College.
