This course provides a practical understanding of data technologies used in clinical trials and is intended to provide attendees with the latest regulations, guidelines and requirements for using electronic data in clinical trials. With the recent widening of the guidelines and regulations to encompass electronic data, it is essential that all persons involved in any aspects of clinical trial data understand the principles and intent of the regulations. Companies must ensure that the QMS processes used in the management of clinical trials fully cover all areas of the regulations in relation to the management and integrity of clinical trial data.