List of Enhancements: Ennov InSight 7.1

Common

Issue Affected Area CHF/Hotfix build Description
26686 Application 6.2.0.7.0006 You can record comments for create/modify actions on Event Country, Sequence Status Date, and Task Status Dates.
  • Event Country Status Comments in Event Country Attributes > Add/Modify-Country Event Status.
  • Sequence-Status Comments in View Sequence > Add/Modify Status.
  • Task Status Comments in View Task > Add/Modify Status.
Comments on status level are modified/deleted by Admin in the discussion thread field.
26581 Application N/A To capture EU Clinical Trial data in Ennov InSight based on the EU 536/2014 regulation, the new EU Clinical Trial Regulation type of application is introduced and includes the ability:
  • To select new fields for Application Country Notifications.
  • To associate Member States Concerned to sequence.
  • To associate/disassociate multiple CT shared data to event.
  • To withdraw a country from application.

Publishing

Issue Affected Area CHF/Hotfix build Description
26747 Assembly 6.2.0.7.0006 Ennov InSight 7.1 now supports Taiwan eCTD Module 1 Version 1.1.
26700 Assembly 6.2.0.7.0006 US 3.3 assembly templates now support eCTD specification v.2.5 and include:
  • the updated xml generation to use https instead of http in dtd reference and stylesheet.
  • two additional folders with US Forms extension:
    • 1.1.10 Form FDA 3988: Transmittal of PMR/PMC Submissions for Drugs and Biologics
    • 1.1.11 Form FDA 3938: Drug Master File
  • fdaft10 and fdaft11 Application Form Type Values
  • REMS Supplement Filing Type with NDA, BLA and ANDA application types for Grouped Submissions.