RCMU services can be utilized to perform project management, assist with specific study components, or fill in for regular research staff as needed.
See below for a list of commonly requested services.
- Feasibility assessment (e.g., review recruitment plan, methods, implementation, timeline, etc.)
- Prepare/submit regulatory documents to the IRB and/or study sponsor
- Develop consent forms and/or study materials
- Develop data collection materials (e.g., case report forms, documentation forms, questionnaires, etc.)
- Train existing research staff
- Establish workflows in an existing environment (e.g., in clinic)
- Screen for and/or recruit study participants
- Enroll study participants and obtain informed consent
- Schedule and conduct study visits with participants
- Collect study data (in-person, by phone, or via chart review)
- Collect and/or process study specimens (may include phlebotomy)
- Distribute study participant payments
- Assist with study reporting (eg. progress reports)
- Complete and organize study records for appropriate storage
- Manage data queries
- Regulatory close out (e.g., IRB application closure)
Because RCMU staff are integrated within TraCS they are able to work closely with other NC TraCS services, such as Biomedical Informatics, Community Engagement, Proposal Development, Recruitment, and Regulatory, leveraging this broad expertise to improve our methods and outcomes.
[RCMU staff has] the concept of running a clinical trial and coordinating within UNC. This makes training the specific protocol or therapeutic area much easier and minimizes training time to start a trial.
— RCMU customer