Clinical Trials Regulation EU 536/2014

Scope of the CTR

CTR regulates all prospective, interventional clinical research where the aim is to study the safety and/or efficacy of a medicinal product. The requirements of the CTR apply to clinical trials of medicinal products for human use, regardless of whether or not they are conducted by commercial operators, and thus also include academically led clinical trials.

Non-interventional studies (observational studies), where patients are treated using medicinal products according to clinical practice, without additional intervention, diagnostics or surveillance, are not covered by the CTR.

Publicity and confidentiality

Clinical Trial Information System, CTIS, is the EU system for clinical trials where applications are submitted and assessed. In the open part of CTIS it is possible to search and read the public information.

Information and links to guidances regarding what information and documentation that subject to publication is found under the heading “Transparency”.

Corrective measures and inspections

Where a Member State concerned has justified grounds for considering that the requirements set out in CTR are no longer met, it may take the following measures: 

• revoke the authorisation of a clinical trial
• suspend a clinical trial
• require the sponsor to modify any aspect of the clinical trial.

Before any of the measures are taken, except where immediate action is required, the sponsor and/or the investigator should be asked for their opinion. That opinion shall be given within seven days.

Supervision of clinical trials is carried out mainly in the form of inspections. An inspection is an official review of, for example, documents, facilities, equipment, examinations, records, sponsor quality review and quality assurance, as well as other activities deemed to be related to the clinical trial.

Inspections are carried out by the national competent authority, which in Sweden is the Swedish Medical Products Agency (Swedish MPA). Inspections may be carried out at the trial site, at the sponsor or company contracted to conduct a trial, or at another location where all or part of the trial is being conducted.

Related information

More comprehensive information can be found on the EMA website.

The EMA publishes educational material on the CTR and CTIS on its website.

European Commission website, Eudralex volume 10.