Single XML Submission File
Ectd 4.0 Moves From A Web-Based, Multiple XML File Structure To A Data-Driven
Format With A Single XML Submission File (Submissionunit.Xml). This Reduces
Structural Updates And Software Release Cycles.
Document Lifecycle Management
Ectd 4.0 Enables Easier Document Lifecycle Operations Like Replacing One Document
With Multiple Documents Or Vice Versa Within The Same Group. Each Document Has A
Universally Unique Identifier (UUID) For Referencing Across Submissions
Bi-directional Communication
Unlike Previous One-Way Submission Models, Ectd 4.0 Enables Bi-Directional
Communication Between Sponsors And Regulators, Facilitating Collaboration And
Feedback
Controlled Vocabularies
Ectd 4.0 Introduces Standardized Terminology And Data Formats Through Controlled
Vocabularies Managed By ICH, Regional Authorities, And Third Parties. This Enhances Consistency And Information Transfer
Flat Submission Structure
The Hierarchical Table Of Contents Is Replaced By A Flat Structure Using Context Of Use Terminology, Keywords, And Sender-Defined Listings To Sort And Display
Submissions
