CTIS has two main workspaces:

• Sponsor Workspace: Used by sponsors, CROs, or legal representatives to prepare and manage applications.
• Authority Workspace: Used by regulatory and ethics authorities in EU Member States.

Users within the Sponsor Workspace are assigned roles such as:

• High-Level Administrator (HLA): Manages user access within the organization
• Submitter: Can create, edit, and submit applications
• Viewer: Read-only access
• Preparer: Drafts the application but cannot submit

Proper role assignment and access delegation are essential for maintaining control and regulatory compliance.

Step 1: Registering in CTIS

Before accessing CTIS, the sponsor’s organization must be registered in EMA’s Organisation Management Service (OMS). Individual users must also register via EMA’s Identity Access Management (IAM) portal.

Key registration steps include:

• Organization registers with OMS
• Users create EMA IAM accounts
• Appoint High-Level Administrator (HLA) in CTIS
• HLA assigns roles to other users

Once configured, users can log in to the Sponsor Workspace to begin preparing trial applications.

Submission, Tracking, and Tips for Effective Use

Step 2: Preparing a CTA in CTIS

A clinical trial application (CTA) in CTIS is composed of two parts:

• Part I: Common scientific data (protocol, IMPD, IB, safety info)
• Part II: Country-specific information (ethics, consent, investigator CVs)

CTIS allows simultaneous submission to multiple Member States. Documents are uploaded per section in structured PDF format. CTIS includes built-in validation tools to identify missing sections.

Sample Table: Required Documents for CTIS Submission

Section	Document	Applicable Part
Protocol	Trial protocol and synopsis	Part I
Investigational Product	IMPD (Quality, Non-clinical, Clinical)	Part I
Ethics & Consent	ICF, PIS, recruitment materials	Part II
Investigator Info	CVs, Good Clinical Practice certificates	Part II

Step 3: Submitting and Managing the CTA

Once the application is prepared, a user with Submitter rights can submit it to CTIS. Member States have 10 days for validation, followed by coordinated assessment (Part I) and individual assessment (Part II).

• Part I Assessment: Coordinated by one Reporting Member State (RMS)
• Part II Assessment: Performed by each Concerned Member State

CTIS allows tracking of each step and supports clock-stops, queries, and amendment responses.

Step 4: Responding to Requests for Information (RFIs)

During review, regulators may raise RFIs. Sponsors receive notifications in CTIS and must respond within the deadline (typically 12 calendar days).

Tips for managing RFIs:

• Use the “History” and “Messages” sections to view communications
• Maintain version control of resubmitted documents
• Assign RFIs to team members based on expertise (e.g., CMC vs clinical)

Managing Amendments and Substantial Modifications

Any substantial changes to protocol, IMPD, or consent forms must be submitted as amendments in CTIS. These follow the same workflow as initial applications.

• Create a new amendment application
• Link to previous CTA ID
• Justify changes and provide tracked versions
• Await approval before implementation

Post-Authorization Activities in CTIS

Sponsors must maintain trial transparency through regular updates in CTIS, including:

• Start and end of recruitment
• Trial status changes (e.g., early termination)
• Summary of trial results within 12 months of trial end

CTIS also generates public summaries accessible to patients and the public.

Best Practices for Using CTIS Effectively

• Schedule internal user training on CTIS roles and interface
• Use EMA’s published CTIS FAQs and webinars
• Set up alerts for regulatory deadlines within the system
• Engage with EMA’s CTIS Helpdesk for technical issues

Sponsors running multi-country trials should maintain a centralized CTIS submission log to monitor timelines, submissions, and responses.

Conclusion: CTIS as a Pillar of EU Trial Harmonization

CTIS is a transformative tool for clinical trial governance in the EU. With its structured interface, unified communication, and role-based controls, it simplifies regulatory workflows while improving trial transparency and compliance.

Mastering CTIS is essential for sponsors conducting EU clinical trials. Through proper training, robust internal processes, and active system use, sponsors can leverage CTIS to optimize trial approvals and stakeholder engagement.