Confimedis Platform v3.16.0

Features

• Documents: Extended Electronic Trial Master File (eTMF) Support
  • A new eTMF view in the documents module arranges all documents that are assigned to the TMF Reference Model by their zones, sections, and artifacts, where every artifact remains visible with the number of its documents, so that gaps in the trial master file stand out.
  • The TMF Artifact can now be assigned in addition to zone and section and covers all 250 artifacts of the CDISC TMF Reference Model.
  • Documents can be assigned to a Location to mark site-level documents, which is shown next to their version and can be used as a filter in both the list and the eTMF view.
  • An Expand menu opens the entire eTMF, only the artifacts that hold documents, or collapses everything at once.
  • The eTMF can be downloaded with all its documents into a folder structure by zone, section, and artifact (with a subfolder per location), while the list offers a Download action for selected documents and folders that keeps the folder structure. The workflow states to include are chosen beforehand, and documents written in the editor are saved as PDF.
  • An entire folder can be uploaded at once via Folder upload, which recreates its subfolders and adds every PDF file it contains as a document, while folders named like a downloaded eTMF (such as 01.01.01 – Trial Master File Plan) assign their artifact to the documents inside, so that a downloaded eTMF can be restored in both views.
• Documents: Document Sharing
  • Documents and folders now have a Share tab like reports and conversations, so that they can be shared with all team members or study participants, or restricted to specific locations, roles, and users, and collaborators can be invited to manage them together.
  • Sharing a folder applies to everything inside it, which is shown in the list as Shared via the respective folder and noted in the Share tab of its entries, where the audience can still be extended.
  • The permission View published documents has been renamed to View shared documents and only grants access to the documents module, while the sharing of each document or folder determines what a user sees. Existing documents were shared with everyone to keep their previous visibility.
  • Roles are available as a new restriction for conversations as well.

Improvements

• Documents: An uploaded PDF file now carries its file name as title instead of New document.
• Documents: The actions of the review workflow now carry a short explanation of what each step does and what becomes possible afterwards.
• Export: Exports that consist of multiple files now download a ZIP archive on browsers without access to the file system, such as Safari, Firefox, and every browser on iOS, instead of reporting an error.
• General: The title of a conversation that is shared with a role now shows the name of the role.
• General: Dropdown menus are now positioned more reliably, so that they appear cut off less often.