This presentation is for a new coordinator or for coordinators who would like a refresher. The presentation will address the creation of comprehensive source documents and how to incorporate source documents within the electronic medical record system without creating more work. Source documentation is critical for obtaining accurate data. The number one cause of FDA 483s reported is that sites are not following the protocol. Therefore, developing well written source documents will provide detailed instructions on the information that must be collected. The presentation will also discuss utilizing the electronic case report form manual to identify additional data points to include in their documentation. Source documents should be organized in such a way that anyone is able to complete a visit without missing essential data points.
Jennifer Kennedy, MSHS, CCRC, MA, Research Coordinator, Sentara Neurology Specialists