New functionalities in the CTIS-module Non-substantial modification

It is now possible to submit non-substantial modifications, where it earlier required submission of a non-substantial modification. It includes amongst others the prolongation of the clinical trial duration. See the full list of functionalities on our homepage and below. 

Tab MSCs:

• Trial subject numbers

Tab Part I:

• Trial information - following sections can be edited;
  • Medical condition
  • Trial duration
  • Source of monetary support or material support
  • Age range (minors cannot be added)
  • Clinical trial group (Healthy, patients, vulnerable)
     
• Protocol
  • All sections can be edited, new documents can be uploadet, existing documents can be opdated
     
• SA and PIP
  • SA can be added/updated 
  • PIP can be updated, if there is an existing PIP, but no new PIP can be added
     
• Associated CTs
  • Associated CTs can be added/deleted
  • Document agreement from another sponsor, can be added/updated
     
• Sponsor
  • Sponsorinformationer can be changed, as long as it in not ORG-ID
  • Co-sponsor can be deleted, but not added
  • Responsibilities can be changed
  • Contact points can be added/changed