Discussing practical issues in regulatory compliance and current regulations that guide clinical trials as well as issues related to cooperative group research (ie: NCI sponsored).

Describing the various types of audits and monitoring visits, how to prepare for an announced visit, and how to respond to a request for an audit from the federal government.

Discussing eligibility, patient safety and practical issues of conducting clinical trials in oncology and cardiology outpatient settings and describe data management requirements for clinical trials.

Discussing  financial components of clinical trials and compliant research billing.

Describing best practices in investigational agent and device management.

Discussing the role of the investigator, the institution, and the need for standard operating procedure when engaged in human subjects research.

Describing important ethical and regulatory aspects of conducting research and the relationship to informed consent requirements

Describing the history and purpose of clinical trials