Training Course
Syllabus:
Protocol Deviations: Documenting, Managing and Reporting Webinar
Objectives of the Presentation
Define protocol deviations Review the requirements for reporting such events to regulatory authorities Review ICH guidelines and Good Clinical Practice (GCP) Discuss Department of Health and Human Services (DHHS) guidance Delve into Food and Drug Administration guidance
Why Should you Attend
Clinical investigators are required to conduct a clinical trial according to the research protocol. Most research protocols are written for an ideal world but the studies are carried out in the real world. This creates deviations, whether planned or unplanned. It is important to know what current expectations are regarding reporting to regulatory authorities to avoid non-compliance issues which can create delays in the conduct of research. Areas Covered
FDA Determination Letters regarding deviations Definition of a deviation What ICH, DHHS and FDA say about deviations Types of deviations Review of institutional guidance documents Examples References
Who will Benefit This webinar will provide valuable assistance to all personnel in: Human Subjects Research, Healthcare interested in exploring the field of Clinical Research, Clinical Research Coordinators, Associates, and Managers, Administration in charge of Clinical Research, Clinical Research Sites, Contract Research Organizations, Regulatory Coordinators, Principal Investigator positions, Sub-Investigators |