CTIS New Sponsors’ FAQ

Written By Elisabethann Wright

‍The EMA has published a new Frequently Asked Question (FAQ) document concerning the Clinical Trials Information System (CTIS) document. The purpose of the FAQ document is to help clinical trial sponsors use the CTIS more effectively by providing responses to the most frequently asked questions that trial sponsors may have when creating and submitting clinical trial applications through the CTIS. The document is divided into five sections:

  • Pre-submission steps

  • Apply for a CT authorisation

  • Evaluation Phase

  • Conduct a clinical trial

  • End the clinical trial and submit results

‍The FAQ document is intended to complement the Sponsor Handbook, which is the main operational guidance for sponsors when using the CTIS.

Elisabethann Wright
Next

Commission Publishes Updated List of Notified Bodies’ Standard Fees