The Compliance Office provides regulatory guidance in the conduct of clinical research at Vanderbilt-Ingram Cancer Center and oversight over the following entities:
Internal and External Audits
NCI Clinical Trials Reporting Program (CTRP) registration, updates and patient accrual
Continuing medical education (CME) credit is available through the quarterly Research Compliance Educational presentations sponsored by the Compliance Office. This series is offered to Cancer Center investigators and clinical research staff on compliance related topics such as Informed Consent, Unanticipated Adverse Event Reporting, HIPAA, Clinical Trials 101 and Investigator Responsibilities.
In addition, the office distributes monthly research related compliance tips to the Cancer Center research community to educate investigators and research staff on Federal guidelines, Good Clinical Practices, institutional policies and departmental standards of operating procedures (SOPs) pertaining to clinical research. The Compliance team supports the CTSR management team in SOP development.
In accordance with the Cancer Center's Data and Safety Monitoring Plan (DSMP), internal compliance audits of interventional cancer trials are performed by the audit staff to ensure the conduct and integrity of the study are of the highest quality and that all trials adhere to regulatory requirements. Exit interviews are scheduled after the internal audit to provide a review of the findings and an opportunity for education and training. The Compliance Office provides guidance and support for investigators and clinical research staff in the preparation and conduct of external audits such as industry-sponsored trials, government sponsored such as NCI/NIH trials and FDA inspections.
For more information, contact:
Assistant Director, Compliance