The clinical research core team promotes excellence in clinical research for human subjects by supporting clinical investigators and their research staff in many activities throughout the protocol life cycle.
Regulatory support
Time can be purchased from a regulatory coordinator on the team to assist with the following activities:
- Creation of master projects in the Rush research portal
- Submission of protocols for coverage analysis, Institutional Review Board review, and/or contract negotiation
- Development of study budgets
- Other study start-up or regulatory matters
Study coordination
Time can be purchased from a regulatory coordinator on the team to assist with all aspects of trial conduct and data management, including but not limited to the following:
- Trial logistics assessment
- Eligibility verification
- Budget development
- Study coordination
- Data collection
- Record retention
- Data safety and monitoring reporting
- Audit and monitoring preparation
- Adverse event assessment and reporting
- Data summary completion for analysis
Training
The team trains and mentors research staff — new hires and established staff. Training sessions are in addition to mandatory requirements, such as the collaborative institutional training initiative and Health Insurance Portability and Accountability Act training.
Training sessions cover a wide range of topics, such as the following:
- Performance expectations
- Protocol interpretation
- Informed consent process
- Research ethics
- Data integrity