The purpose of this course is to provide an orientation for novice personnel working in the cancer clinical trials enterprise and a review of the basics of cancer clinical trials quality for research professionals. Objectives -List key elements of cancer development and growth -Define the role of clinical trials in quality cancer care -Examine the elements of good clinical practices in research with human subjects -Evaluate comprehensiveness of site standard operating procedures (SOPs) for clinical trials -Describe procedures for protecting human subjects in clinical trials -Define the role of the Institutional Review Board and CIRB in cancer research -List procedures required for submission of a research protocol to the IRB/CIRB for review and approval -Discuss key elements of a clinical trial protocol -Discuss role of genomics in cancer research -Define critical components of regulatory accountability for clinical trials -Discuss the process of accountability of drugs used in clinical trials -Describe procedures for an internal and/or external monitoring activity -Describe components of developing a budget for conduct of a clinical trial -List four resources to improve access and enrollment of patients to cancer clinical trials in Georgia Contact Hour Credits This activity has been submitted to Montana Nurses Association for approval to award contact hours. Montana Nurses Association is accredited as an approver of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. Registration Fee: $25.00 The registration fee includes lunch each day, snacks, and a course syllabus.

Contact

Jane Clark, PhD, RN (404) 421-6041