February 2023: Questions and Answers on CTIS and the CTR

On February 10, 2023, European Medicines Agency uploaded the document ‘Questions and answers by the Query Management Working Group on CTIS and the CTR‘ over the What’s new section.

A Q&A document is uploaded to answer questions related to the CTIS and the CTR by the Query received from the different stakeholders and answered by the Query Management Working Group. Question number 60 to 78 answers questions related to transparency. These questions are divided into below categories:

  • Assessment
  • Clinical Trial Application under the CTR
  • CTIS Implementation
  • GDPR
  • Master Data Sources (SPOR/xEVMPD)
  • Non-EEA 3rd countries
  • Safety/ASR
  • Training & Support
  • Transition Period
  • Transparency
  • User Management