The TrialMaster, First in Functionality, EDC solution offers so much more than traditional electronic data capture. The breadth of functionality that is inherent in the product coupled with the ability to perform tasks typically seen in multiple clinical applications, is unrivaled by any other EDC solution in the industry. This unique product is ideally suited for electronic data capture in Phase I trials. The archive feature presents your data (post lock) in TrialMaster browser view (tree configuration) delivered to you via CD in read only format with the ability to export to study specific formats. The FDA Submission Module creates a Casebook containing PDF formatted copies of all Case Report Forms (CRFs) in FDA submission format. TrialMaster Safety provides for the coding and storing of SAE information either in a manually entered mode directly into a web-based form or automatically from event-driven information from a clinical study EDC system such as TrialMaster.