Description
CRC For Beginners :
This course will provide practical strategies for experienced CRCs to orient, train and supervise new CRCs, RAs, and MAs. During the course you will learn the strategies of development of standardized orientation programs that cover essential topics. We will discuss continued training and professional development for experienced CRCs.
During the course of training students will participate in many simulation exercises that will expose you to actual trial situations with the Sponsors, PIs, CRAs, other clinical research professionals, and participants.
Course Outline
- Introduction to Clinical Research. Main principles, history, and future perspectives.
- Clinical Research Team
- Good Clinical Practice
- GDP
- HIPAA
- Phases of clinical trials
- Investigational Product (IP) Development.
- The Clinical Study Protocol and Study Feasibility
- Site Selection, and Study Initiation
- A consent form, IRB, and HIPAA
- Safety Reporting
- IP Accountability, Essential Documents, and Routine Monitoring Visits
- Source Document Verification, Data Management, and the Trial Close-out Visit
- Mock study review
- Mock Audits & Inspections
