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eCTDmanager Basic Training Course


Content
  • What's New in 24.02
  • What's New in 23.10
  • Harmonized Release Numbering 23.06
  • What's New in 23.06
  • What's New in 9.2
  • What's New in 9.1
  • What's New in 9.0: Creating a Companion Folder Structure for Working Documents
  • Section 1: Introduction and Background
  • eCTDmanager - EXTEDO's eCTD Management Software Solution
  • Background Information: Structure of an eCTD (1:30)
  • SECTION 2: GETTING FAMILIAR WITH ECTDMANAGER
  • Start the eCTDmanager (0:35)
  • The User Interface (0:40)
  • Window Handling and Menus (1:30)
  • Quit eCTDmanager (0:15)
  • Section 3: creating dossiers and submissions
  • Create a new Dossier (1:00)
  • Test: Creating a Dossier
  • Section 4: The M1 Regional Part
  • EU Module 1: Adding Documents (5:45)
  • EU Module 1: Envelope in version 3.0.3/3.0.4 (2:40)
  • Test: EU Module 1
  • Examples for other eCTD Regions, here GCC (1:40)
  • SECTION 5: SPECIFIC SECTIONS, NODE EXTENSIONS, Document operations
  • Create Specific Sections (1:15)
  • Managing Documents, the Interim Document (4:10)
  • Node Extensions (0:45)
  • Copy Branch (0:40)
  • Test: Specific sections, document handling, Interim Documents
  • Section 6: Hyperlinks
  • Create Hyperlinks manually (4:45)
  • Automatic resolution of Hyperlinks (1:45)
  • Hyperlinking for Experts: "Create Hyperlinks from Text" (5:20)
  • Test: Hyperlinks
  • Section 7: Pre-validation, task tracking. Finish and export a Submission
  • Pre-validation of a submission, task tracking and finish a submission (1:50)
  • Export a submission (1:50)
  • Validate Business Rules after Export (1:15)
  • Test: pre-validate, finish & export a Submission
  • Section 8: Submission- and Document Lifecycle
  • Submission Lifecycle (0:55)
  • Edit envelope in follow-up submissions (0:50)
  • Test: Submission Lifecycle
  • Document Lifecycle (3:35)
  • Test: Document Lifecycle
  • Section 9: Other document related features
  • MiniDMS: edit Documents (2:30)
  • MiniDMS: Check for New Version (1:00)
  • Edit Document Bookmarks (1:20)
  • Test: Edit Document Bookmarks
  • Section 10: WORKING WITH FOLLOW-UP SUBMISSIONS
  • Export Follow-Up submissions (0:55)
  • Lifecyle icons in follow-up submissions (0:15)
  • Test: Follow-up-Submissions
  • Section 11: Re-using Dossiers and Submissions
  • The Cumulative Submission, Replace the regional Part (1:35)
  • Test: Re-using Submissions
  • Section 12: Importing eCTD Submissions and Dossiers
  • Business Cases for Importing Submissions and Dossiers (1:00)
  • Importing single eCTD sequences (2:20)
  • Batch Import of Dossiers (2:20)
  • Test: Importing Submissions and Dossiers
  • Section 13: Submission Staging
  • Submission Staging: working on parallel submissions (5:40)
  • Test: Submission Staging
  • Section 14: EU multinational procedures - MRP and DCP
  • EU Multi-national procedures: MRP and DCP (7:20)
  • Test: MRP and DCP
  • Section 15: Additional Features
  • Full-text search (1:25)
  • Generate Reports (1:15)
  • Annotations, Highlights, Scratch Book (5:25)
  • Submission QC Export (1:10)
  • Test: Reviewing Tools
  • Section 16: Basic Administration and Maintenance
  • User Management (1:00)
  • Using the Audit Trail (1:00)
  • Maintenance: the Lock Manager (1:00)
  • Maintenance: Build Search Index (0:25)
  • Basic System Configuration: Edit Settings (0:55)
  • Section 17: System Infomation and Documentation
  • System Documentation: the Help System (0:50)
  • System Information: About eCTDmanager (0:40)
  • System Information: License Information and Status (0:55)
  • Section 18: eCTDmanager in the EXTEDO Suite
  • Submission Content Planning and Tracking with eCTDmanager and eSUBmanager
  • eCTDmanager and eDOCSmanager: Introduction and Overview
  • Training Feedback
  • Training Evaluation Form
Completion rules
  • You must complete the units "Test: Creating a Dossier, Test: EU Module 1, Test: Specific sections, document handling, Interim Documents, Test: Hyperlinks, Test: pre-validate, finish & export a Submission, Test: Submission Lifecycle, Test: Document Lifecycle, Test: Follow-up-Submissions, Test: Re-using Submissions, Test: Importing Submissions and Dossiers"
  • Leads to a certificate with a duration: 1 year
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