Clinical Research
The Clinical Trials Cluster is organized to provide a full spectrum of support services to CTSA investigators engaged in human subject Research. The Cluster’s overall goal is to facilitate clinical and translational research projects, from conception to completion of subject recruitment to achievement of research objectives, with attention to the ethical conduct of research, the protection of human subjects and the integrity of clinical trial data. Clinical research is a robust activity at the University of Chicago with more than 2000 IRB approved protocols representing the work of over 400 investigators.
Institutional Review Board (BSD)
- The Regulatory Knowledge and Support Component of our CTSA Program is administered through the Clinical Trial Cluster. Specific objectives include:
- Promote protection of human subjects and facilitate regulatory compliance in human subjects research
- Facilitate communication among CTSA investigators, Institutional Review Board, University Research Administration, and administrative and research staff in the initiation and conduct of clinical research studies
- Insure that clinical research studies comply with the applicable NIH, FDA, CMS and OHRP regulations and that they are conducted according to Good Clinical Practices
- Provide research subject advocates to work with University of Chicago and Community investigators, trainees and research teams to insure appropriate data and safety monitoring for all clinical research studies and to serve as independent sounding boards to potential research participants
- Facilitate the development and initiation of clinical trials by providing tools for protocol and informed consent authoring and assistance in submission of the regulatory documents
- Foster best practices for conducting clinical trials; designing source document templates and communicating Clinical Research Policies
- Provide an infrastructure for compliant clinical trial budgeting and billing
- Assure data integrity for investigator initiated studies by performing periodic internal reviews or audits for clinical trial data;
- Develop the appropriate informational technology platforms for clinical trial data management
- Provide comprehensive training and educational opportunities for CTSA investigators and research staff in clinical research methods, regulatory requirements, study conduct, team building and financial management for clinical research studies
- Coordinate implementation of conflict of interest management plans developed by the Provosts’s Office