eCTDXPress 103: Assembling Submissions

Course Description
This four-hour course takes users through building and compiling submissions with eCTDXPress. In this course, students will learn how to create applications and sequences, add files and hyperlinks, work with STFs and node extensions, set locking statuses, and compile an eCTD. Students will also learn how to import and clone submissions for other regions.

Who Should Attend
This class is designed for users and managers who will be involved in building eCTDs.

Prerequisites

• The basic operation and function of Microsoft Windows and Adobe Acrobat
• Use of a mouse, standard menus and commands
• Basic understanding of electronic submissions and granularity

Course Length
Four hours.

Topics Covered

• Creating Applications in eCTDXPress and FirstDoc
• Adding and Modifying Submission Metadata
• Customizing a Workspace for Submission Assembly
• Navigating and Viewing the Application
• Adding Files from a file share and DMS
• Adding Hyperlinks with Virtual Link Manager
• Working with Study Tagging Files and Node Extensions
• Setting Locking Statuses
• Compiling and Validating Submissions
• Creating New Sequences in eCTDXPress and FirstDoc
• Lifecycle Management
• Working with Comments
• Importing Submissions
• Cloning Submissions for Other Regions