Selecting and Implementing Electronic Data Capture (EDC1)
February 13 – March 12
The course will address evaluation of systems, user requirements, and process change and implementation of systems, as well as training. A sample protocol will provide application of learning to real world situations.
Over four weeks, this course will address general principles, best practice and issues to consider for choosing and implementing an EDC platform. The focus will be on the choices required to meet the business needs of an organization, whether using EDC as a sponsor directly with an EDC vendor or a sponsor partnered with a CRO.
Topics will include designing the application to interface with other data components such as ePRO, IVRS and Central Labs. Participants will gain insightful examples of how to perform and document UAT; set up EDC users, roles and permissions; and to comply with regulations that affect data collection in an electronic format. Collaboration and communication with appropriate team members during all phases of clinical trials will be highlighted.