CTIS - Update of Important Sponsor Documents

The EMA regularly updates the essential documents for sponsors regarding the CTIS (Clinical Trials Information Services). Both the Sponsor Handbook and the summary of the CTIS FAQs have been published by the EMA in updated versions:

• Sponsor Handbook (Version 6.2)
• Sponsor Frequently Asked Questions (FAQ) (Version 1.0).

The CTIS Sponsor Handbook is the reference document that sponsors of clinical trials should use when applying for clinical trial authorization via CTIS. They should also use the handbook when entering additional information into CTIS.

The Handbook is intended for:

• Pharmaceutical companies
• Contract Research Organizations (CROs)
• Small and medium-sized enterprises (SMEs)
• Academic sponsors
• Other organizations involved in clinical trials.

The new CTIS Sponsor Frequently Asked Questions (FAQ) is based on questions frequently asked by sponsors during CTIS events such as walk-in clinics, bite-size presentations, and via the EMA CTIS Service Desk. It serves as a supplementary document to the revised Sponsor Handbook, the primary guide for sponsors on CTIS-using. The mentioned documents are available at EMA`s Clinical Trials Information System (CTIS): training and support website.