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ForwardAn Introduction to Clinical Research-June 12, 2018
June 12, 2018 to June 13, 2018
The purpose of this course is to provide the nurse/physician/pharmacist/coordinator/administrator an overview and understanding of clinical research in oncology and cardiology with an emphasis on patient safety, adherence to relevant regulations, and quality data collection.
Target Audience
Physician-investigators, research nurses, coordinators and other research staff, administrators with oversight of research programs, pharmacists
Learning Objectives
Describe the history and purpose of clinical trials.
Describe important ethical and regulatory aspects of conducting research and the relationship to informed consent requirements.
Discuss the role of the investigator, the institution, and the need for standard operating procedures when engaged in human subjects research.
Describe best practices in investigational agent and device management.
Discuss financial components of clinical trials and compliant billing practices.
Discuss practical issues of conducting clinical trials in the oncology and cardiology outpatient setting.
Describe data management requirements for clinical trials.
Discuss eligibility and patient safety once on study.
Describe the various types of audits and monitoring visits.
Describe how to prepare for an announced audit.
Describe best practice for responding to a request for audit from the federal government.
Discuss practical issues in regulatory compliance.
Describe current regulations that guide clinical trials.
Discuss regulatory issues related to cooperative group research (NCI-sponsored).
Durham, NC
United States
Available Credit
- 12.50 ACPE - Pharmacist
- 12.50 AMA PRA Category 1 Credit(s)™
- 12.50 ANCC