Standard Operating Procedures (SOPs) Development and Implementation

The goal will be accomplished through lectures, discussions and activities. This workshop will be facilitated by clinical research professionals with experience in clinical research as well as experience and expertise in the development and implementation of SOPs. Information will be presented and discussed on what SOPs are, why we need such documents, how to develop SOPs, how to prioritize the implementation of the various SOPs required at the investigational site, and how to implement and use SOPs. Discussion will consider issues related to the use of, and impact of SOPs. Additionally, discussion will continue regarding the importance of strategies for addressing the approval process, development of a training program, and tracking of training and implementation results.