NRSG 823. Research Clinical Trial Management: Pre-Study Activities. 3 Hours.

This course is designed as an introduction to the research clinical trial manager role and provides in-depth knowledge of Pre-Clinical Trials Study activities. Regulatory, administrative, and ethical issues will be presented as well as the daily operational requirements (study design, financial aspects, protocols, hiring of personnel, subject recruitment, etc.) to begin a study. Included is the development of training skills for the Clinical Trial manager for critiquing sample protocols and for assessing adequate resources for implementation of protocol. Prerequisite: RN Licensure, graduate level, or consent of instructor. LEC.