Quality Management assists in ensuring clincial trials are conducted properly, in accordance with Sylvester protocols. The office reviews all institutional protocols for completeness prior to submission to the Protocol Review Committee (PRC). This ensures protocols contain all the required elements of research protocol design. In addition, the office provides administrative support for the PRC and Data and Safety Monitoring Committee (DSMC).
The office’s other key responsibilities include:
- Coordination of protocol submission to the PRC and other required pre-IRB regulatory committees
- Review of patient eligibility prior to enrollment in institutional protocols
- Oversight of cooperative group patient registration, randomization, and data submission
- Maintenance of investigator credentials, research patient files, and CRS’ standard operating procedures
Please contact CRS at 305-243-4903 for more information.