Society of Clinical Research Associates-Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance and Good Clinical Practice

摘要

The Food and Drug Administration (FDA) is announcing an educational conference cosponsored with the Society of Clinical Research Associates (SOCRA). The public conference regarding FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRBs). Individual FDA representatives will discuss the informed consent process including informed consent documents, regulations relating to drugs, devices, and biologics, as well as inspections of clinical investigators, IRBs, and research sponsors. Date and Time: The public conference will be held on May 13 and 14, 2015, from 8 a.m. to 5 p.m. Location: The conference will be held at The Westin Cincinnati, 21 East Fifth Street, Cincinnati, OH 45202; 513-621-7700. Attendees are responsible for their own accommodations. Please mention SOCRA to receive the hotel room rate of $169 plus applicable taxes (available until April 15, 2015, or until the SOCRA room block is fi