July 2021: CTIS Updates

European Medicines Agency published a few documents related to the Clinical Trial Information System, on July 29, 2021.

The Clinical Trial Information System (CTIS) – Sponsor Handbook provides detailed information regarding the use of the new system including user management, documents submissions throughout the life-cycle of a clinical trial and directions for users during the 3-year transition period. Section 9 explains data transparency. The data and documents submitted to the CTIS for the trial will be made available to the public. Personal and commercial confidential information are exempted from publication. Thus, the system will accommodate for two versions of the trial documents, one ”for publication” (redacted) and one ”not for publication” (not redacted). Provisions for deferrals will be applicable for redacted documents.

Additionally, the below templates were also made available on the same day. All these templates provide an overview of the system covering screenshots of the different sections associated with each type of application:

CTIS Structured data form Instructions – initial application, additional MSC, substantial and non-substantial modifications: Provides guidance on the data fields sponsors will fill in CTIS when creating an initial application (IN), an additional member state concerned application (AMSC), a substantial modification (SM) and a non-substantial modification (non-SM). It also covers the document types involved in each form and the availability of publication and deferrals for these.

CTIS Structured data form Instructions – multi-trial substantial modification: Provides guidance on the data fields sponsors will fill in CTIS when creating a multi-trial substantial modification. This application differs from the above-mentioned ones in the way that i) it has all fields that are editable in the Form section ii) there is no MSCs section and iii) Part I and II are not editable; are pre-populated. It also covers document type, publication and deferral related details.

CTIS Structured data form – Notifications: Provides guidance on the data fields sponsors will fill in the ‘Notifications’ sections in CTIS. The different notifications include start, end and restart of both trial and recruitment, temporary halt, global end of trial, unexpected event, serious breach, urgent safety measure, inspection and updating results date.

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