Dear UM Research Community,
On February 15, 2023 we communicated the Enrollment Tracking Using REDCap policy to the UM community. Since the launch date, and through subsequent dialogue with human subject researchers from across the University of Miami, we have streamlined our implementation strategy to be responsive to feedback.
If a protocol meets the REDCap criteria, study teams will now be required to report aggregate accruals data for participants, including race, ethnicity, biological sex, and age. It is the responsibility of UM faculty and research personnel to report their accruals on either a quarterly or an annual basis, depending on the type of research project.
- For research projects requiring informed consent, the REDCap Aggregate Accruals of Study Participants Template must be used to report quarterly accruals.
- For research projects with an informed consent exemption or that are IRB-exempt, the REDCap Aggregate Accruals of Study Participants Template must be used to report annual accruals.
The data collection form (Aggregate Accruals of Study Participants Template) was modeled on the enrollment reporting forms utilized in federally funded human subject research.
Workflow for Studies Requiring REDCap
As of Monday, March 20, 2023, when an IRB protocol is approved, a notification will be sent to the Principal Investigator, PI Proxies, Primary Contact, and Research Coordinators/Assistants for protocols identified as needing to use REDCap to report aggregate participant accruals. The notification will include a link to a new REDCap Accruals Reporting project with the Aggregate Accruals of Study Participants Template. If you already have a project in REDCap, a new project will be automatically created specifically for aggregate accruals reporting. This will prevent disruptions to your existing REDCap project(s).
Reminder notifications will be sent when reporting of aggregate participant accruals is due. Protocols requiring informed consent will receive quarterly reminder notifications starting three months after IRB approval. Protocols with an informed consent exemption or that are IRB-exempt will receive annual reminder notifications starting one year after IRB approval. These reminder notifications will continue until the protocol is closed.
A step-by-step video overview of this process will be shared with the research community next week. In the meantime, you can review this decision tree to determine which requirements apply to your protocol and which notifications will be received.
Informational Sessions and Training
There will be 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:
