Center for Professional Innovation & Education (CfPIE), King of Prussia, PA
Sep.10 & 11, 2012
This course will benefit all product development and clinical team members who touch some aspect of clinical documentation, and help them understand the importance of a robust clinical document management system that meets specific trial needs. By the end of this two-day session, attendees will understand the varied documentation requirements of global clinical trials and be able to assess documentation needs in the context of electronic, paper or hybrid systems. Additionally, participants will develop a firm understanding of the roles and responsibilities of sites, sponsors, CROs and other stakeholders in relation to clinical documentation. Development of Standard Operating Procedures (SOPs), the Trial Master File and conducting compliant audits will also be given significant attention.
|
|