Best Practice Guide for Transitional Clinical Trials

Clinical trials (CTs) will be allowed to transition from the Directive 2001/20/EC (CTD) to the EU Regulation 536/2014 (CTR) before the end of the 3 years following the date when the CTR applies, in accordance with the Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation. However, only clinical trials authorized under the CTD with at least one active site in the EU on 30 January 2025 need to be transitioned.

For transitioning multinational CTs with different protocol versions approved in different Member States under the CTD to the EU CTR sponsors will be required to have a harmonized (i.e., via substantial amendments) or consolidated protocol. A consolidated protocol does not require a substantial amendment if it properly reflects the scope and conditions of the authorizations of the CT in each of the Member States Concerned (MSCs) and complies with the CTR. It is the sponsor's responsibility to ensure that a consolidated protocol reflects what is authorized in each of the MSCs.

Moreover, it is required that all other documents common to all MSCs, i.e. those documents covered by the Part I assessment report, will be harmonized (e.g. Investigator’s Brochure, Investigational Medicinal Product Dossier, IMPD). Transition of multiple versions of a protocol or other Part I documents within one application under a single EudraCT number will not be possible. Therefore, sponsors should only upload one protocol document for each trial in the CTIS (Clinical Trials Information System).

To help sponsors during this process, the Clinical Trials Coordination Group (CTCG) has published a Best Practice Guidance and a template cover letter.

The following documents are available:

• A 3-page Best Practice Guide for sponsors of multinational clinical trials with different protocol versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014;
• A 2-page Annex with information that should be provided in the cover letter of applications for transitioning a Clinical Trial authorized under the Directive 2001/20/EC to the CTR.

More information is available at the CLINICAL TRIALS COORDINATION GROUP (CTCG) website under NEWLY ADOPTED DOCUMENTS.