\u27Hot Topics\u27 and Practical Considerations for Protecting Human Research Participants

This conference is designed to aid the Clinical Research Professional’s understanding of current ‘Hot Topics’ as well as the practical considerations in human subjects research. This two-day conference for Clinical Research Professionals will study, explain and discuss how ICH GCP and the Code of Federal regulations guide and direct investigator responsibilities, IRB management issues, audits, the informed consent process, and administrative activities. The attendee will understand and be able to convey the responsibilities of these very important functions and the complementary role of the clinical researcher as a fundamental contributor to successful clinical research and the protection of research subjects. The program will focus on the relationships among clinical trial staff, investigators, IRBs the FDA, CROs and sponsors. The conference will highlight areas that present challenges to sponsors and investigational sites: writing informed consent documents, the informed consent process, use of genomic data, future use of stored bio-specimens, communication, and research fraud. The program will identify best practices and strategies to provide potential solutions for these challenges