DefinePDF^® is a one-step solution to automatically create the entire CRT section of an electronic submission, along with define.pdf, SAS transport files and table of content files with all of the necessary links and bookmarks. DefinePDF is a stand alone application that utilizes SAS in the background, with required user input such as: datasets, formats and metadata, and creates the entire CRT along with: SAS v5 transport files, define.pdf or define.xml following CDISC standards and latest FDA requirements.

Features:

• Supports entire CRT section creation for a given submission along with crttoc.pdf and datatoc.pdf
• Central Repository to store and manage the metadata. Also, metadata management within the DefinePDF application with in-line editing capability
• Multi-User access with security, using domain user-id and password
• 21 CFR Part 11 compliant audit-trail to keep track of change control
• Administrative features for application maintenance
• Capability to produce RTF, HTML & XML output in addition to PDF
• Supports multiple data sources and SAS dataset versions
• MDI feature to support multi-study operations within a session
• Allows user-defined table properties, font attributes and page orientation
• CDISC SDM (Submission Data Model) verification. Verifies and reports whether your datasets and variables are in compliance with SDM model
• CDISC SDTM and CRT-DDS standards compatible
• Centralized backbone and study setup feature to ease the client side maintenance (i.e. all necessary information can be managed on a shared network area so that multiple users can access it simultaneously)
• Ability to create links to annotated case report form (blankcrf.pdf) and to external documents