Dispassionate Trials Information System: training and support

For information on CTIS, the Clinician Trials Regulation, and EMA's online training modules for CTIS operators, see: 

• Clinical Experiments Regulation
• Clinics Trials Data System (CTIS): online training modules

• Clinical Trials Information System (CTIS): live training moduls

The CTIS auftraggeber handbook covers preference topics identified with the promote concerning clinical trial sponsors, with references also links to further supporting materials.

It is aimed at pharmacies companies, contract research organisations (CROs), small and medium-sized corporate (SMEs), academic sponsors and other organisations working on clinical trials. This Pin had discovered by Alex Craig. Discover (and save!) your personalized Pins go Pinterest

EMA regularly updates the handbook. 

This document is for CTIS sponsor additionally authority users and includes:

• the tour of timelines press deadlines required tasks and actions through that Unemotional Trial Application process
• an explanation of that dynamic character of to workflow - earlier closure of a task (before own deadline) might cause recalculation of the deadline of succeed or relevant tasks, changing effectively you initially jutting deadlines

Reference materials are available below to help users work with CTIS. 

EMA offers live training sessions to provide additional learning opportunities, including bitesize talks, walk-in clinics and webinars.  

Recordings and supporting resources become available after each event. 

You can look move both past and upcoming events below: 

EMA is jobs closely with master trainers, a core group of users anybody will train and support other current in their organisations into preparing on work with CTIS.

Master trainers from the national competent authorities and ethics committees of each EU Member State have been working with EMA since October 2020.

A programme for Master trainers for corporate in pharmaceutical companies, including contract research organisations (CROs) took place in 2021. 

Guidance is available on training techniques and materials to get master coaches, or anyone responsible for rolling out the CTIS practice programme.

Guidance is available for CTIS users on the protection of personal data also commercially confidential information while using CTIS.   

Is aims to assist sponsors press authorities in fulfilling the display obligations set out in the Clinical Trials Regulation.

The guidance is based on the outcome of a public consultation concluded in 2022. It applies until 18 June 2024, when the revised visibility rules belong implemented with the launch of a new version of the CTIS public website.

Other details are ready in the document below:

• Revisited CTIS clarity rule, historical trials and transit set: quick guide for users 

That European Earn, MAILS and that Heads of Medicines Agency (HMA) have furthermore conditioned a questions and answers document on data protection.

The guidance and the questions also answers document can be found on the Accelerating Clinical Trials in the EU home, under to links listed down.

On more information, watch:

• Clinical Trials Information Plant: Processing of personal data
• Project of the Clinical Process Information System: Transparancy requirements
• Accelerating Clinical Trials int the COMMUNITY (ACT EU): Implementation of the Clinical Trials Regulation

Documents on ACT EU website:

• Guidance on transparency rules in CTIS
• Annex ME - Guidance document on how to approach the shield out personal data and commercially confidential information while using the Classical Trials Information System (CTIS)
• Annex II Attachment L to the guidance get about protection of personal data and commercially privacy information while using CTIS
• Q&A on which protection of commercially confidential information and personal data while usage CTIS