EMA’s CTIS Framework: Decoding the EMA Clinical Trial Information System-A Practical Guide for Sponsors

In an era of data-driven drug development, the European Medicines Agency (EMA) has launched a transformative regulatory framework: the Clinical Trial Information System (CTIS). This centralized digital platform, established under Regulation (EU) No 536/2014 (the EU Clinical Trials Regulation or CTR), is designed to simplify and harmonize the clinical trial application and management process across the European Union (EU) and European Economic Area (EEA).

EMA updated and released the below documents to to help sponsors effectively use CTIS.

1. CTIS Sponsor Handbook

2. CTIS Training Material Catalogue

3. CTIS Structured Data Forms – Initial & Modification

4. CTIS Structured Data Forms – Notifications, ASRs & Results

The Clinical Trial Information System (CTIS) is a web-based platform that serves as a single-entry portal for clinical trial submission, assessment, and supervision within the EU/EEA.

It supports:

• Submission of initial clinical trial applications

• Substantial and non-substantial modifications

• Safety reporting and trial result publication

• Real-time interaction between sponsors and national authorities

• Public transparency of trial-related information

CTIS is built on a dual-access model:

• Sponsor Workspace – for trial sponsors to submit and manage trials

• Authority Workspace – for national regulatory and ethics bodies

Key EMA Resources and Insights

1. CTIS Sponsor Handbook: Practical Navigation Tool

The Sponsor Handbook is a go-to manual that explains CTIS functionalities in detail, providing real-life use cases, workflows, and screenshots.

• Explains how sponsors can create, submit, and manage clinical trials

• Describes role-based user management and access control

• Highlights communication protocols (e.g., RFIs – Requests for Information)

• Breaks down the submission workflow for mono- and multi-member state trials

• Emphasizes the importance of internal coordination to meet CTR deadlines

2. CTIS Training Material Catalogue: Structured Learning Support

This catalogue outlines all available training modules and learning aids that support users of CTIS, categorized by role and system activity.

• Lists more than 50+ resources: e-learnings, webinars, job aids, simulations

• Covers essential operations like:

  • Creating an initial application

  • Responding to RFIs

  • Uploading trial results

• Structured by user roles: Sponsor Admin, Clinical Trial Submitter, Viewer, etc.

• Provides a navigation matrix to match training materials to user needs

3. CTIS Structured Data Forms – Initial Application & Modifications

This structured Excel-based template is designed for:

• Initial trial applications

• Adding additional Member States

• Making substantial or non-substantial modifications to a trial

• Captures critical trial data such as:

  • Study phase

  • Therapeutic area

  • Inclusion/exclusion criteria

  • Trial population and endpoints

• Ensures data consistency and alignment with CTR Article 25 requirements

4. CTIS Structured Data Forms – Notifications, ASRs, and Results

This template facilitates ongoing trial communications such as:

• Start and end of trial notifications

• Temporary halts or resumptions

• Submission of Annual Safety Reports (ASRs)

• Uploading clinical trial results for public access

• Data is organized in logical sections to guide:

  • Timely reporting of safety signals

  • Regulatory updates across trial Member States

  • Result disclosures post-trial completion

• Includes flags for public disclosure vs confidential data

Sponsors now have the tools to navigate complex regulatory requirements with improved clarity, collaboration, and accountability. For pharmaceutical sponsors, embracing CTIS is no longer optional—it's essential for compliant, high-quality clinical trial operations in the EU.