Protecting Human Research Participants : Legal, Ethical, and Practical Considerations

SOCRA is proud to announce this conference on Protecting Human Research Participants. The conference is designed to aid the Clinical Research Professional's understanding of the legal, ethical, and 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 record keeping, 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: safety reporting, data monitoring, communication, education, and the informed consent process.