January 2023: Quick Guide for Sponsors – Regulation 536/2014

On January 30, 2023, European Union (EU) uploaded a document ‘Quick guide for sponsors – Regulation 536/2014 in practice (Eudralex vol. 10)‘ on its official site European Commission.

Sponsors and investigators can refer to this guidance document for understanding the rules and procedures of the Clinical Trials Regulation (EU) No 536/2014 with a view to its implementation. Below are the topics that are covered in this document:

  1. Key principles of CTR
  2. Transition period of CTR
  3. Steps to be taken before the start of a clinical trial
  4. Steps to be taken during the conduct of the clinical trial
  5. Steps to be taken once the clinical trial has ended
  6. Protection of commercially confidential information and personal data
  7. Composition of the clinical trial application in CTIS
  8. Calendar for the initial authorization of a clinical trial
  9. Overview of the notifications in CTR