|Event Name||BayBio 2012 Development of Clinical Standard Operating Procedures - UCSC Extension
Tuesday, June 26, 2012
Tuesday, March 27, 2012
UCSC Extension in Silicon Valley, 2505 Augustine Drive, Suite 100
|Description||The U.S. federal regulations and ICH guidelines for good clinical practice require that all institutions and entities involved in research with human subjects develop and maintain written standard operating procedures (SOPs). However, many companies do not develop policies and SOPs until after human clinical trials are well underway. This course, aimed at clinical research associates, clinical research managers, and clinical operations directors and associate directors, examines the regulatory requirements and the differences between regulations, guidelines, policies and SOPs, and evaluates the components of a well-constructed SOP. Participants develop SOPs for critical clinical functions, such as safety reporting and data handling.
|Host Company||BayBio (Bay Area Bioscience Association)