CTIS & CTR: Sponsor Questions & Answers

Recommendation

4-6 June 2024
Munich, Germany

Qualified Person Education Course Module A PLUS IMP Pre-Course Session
Understand the Implications of becoming a QP

EMA's Query Management Working Group (QMWG) prepared a document to address the main questions received from sponsors about CTIS and the Clinical Trials Regulation. The EMA published this document in February 2023.

The questions related to CTIS and the CTR, received from different stakeholders, were collected and categorized by themes. Each category is presented in a table along with the questions and answers (Q&As) provided by the QMWG. The following 11 categories with corresponding Q&As are provided:

• Assessment (e.g. How can the sponsor monitor messages and information that have been submitted to the sponsor if there is no
  e-mailing functionality?)
• Clinical Trial Application under the CTR (e.g. Should the documents be uploaded with signature?)
• CTIS Implementation (e.g. What are the character limits for the different free text structured data fields and the document titles in CTIS?)
• GDPR (see also the Questions and Answers on Data Protection)
• Master Data Sources (e.g. What is the link between xEVMPD and SPOR? Which organizations in CTIS need to have an OMS ID?)
• Non-EEA 3rd countries ( e.g. Can one inspection report be associated to multiple studies, or does it need to be submitted for each study individually?)
• Safety (e.g. Is it required to submit the ASR directly to the Ethics Committee and can it be done via the EV database?)
• Training & Support (e.g. Is there any technical support available on CTIS, e.g. online helpdesk or live chat? Are there any templates available for the different types of documents that need to be uploaded in CTIS?)
• Transition Period (e.g. How can the sponsor get ready for CTIS during the transition period?)
• Transparency (e.g. If an information/document is made public by mistake, what’s the process to get it removed from public view?)
• User Management (Is there any guideline for sponsors on user management in CTIS? E.g. how to use the user management functionalities; how to manage user permissions and understand the user roles better?) (see also the Sponsor Handbook and the Quick guide for Sponsors)

For more information please see the Questions and answers – Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR) published at EMA´s Clinical Trials Regulation website.