The Case Report Form Process

This course focuses on the data flow process for both paper and electronic Case Report Forms (CRFs). It outlines the responsibilities of the different parties involved, including sponsors designing CRFs and monitors training site personnel, and also looks into the key factors of data handling, including completion, data management, and query processing. Both the use of paper and electronic case report form processes are covered.  Examples of frequently found data entry errors will help monitors to develop the necessary reviewing skills.