Eudract

EudraCT is the acronym for "European Union Drug Regulatory Authorities Clinical Trials". This is a European register for clinical trials with medicinal products that has existed since 2004. EudraCT is maintained in English by the European Medicines Agency (EMA) and serves to monitor and increase transparency in the approval and conduct of AMG studies.

According to GCP, a registration in EudraCT must be made before the start of a drug trial, which results in an EudraCT number being assigned. The number is sent by email, after which the required information can be entered into the database using this number. The application for an EudraCT number is carried out as follows:

On the EudraCT start page, under the 1st item "Apply for Security Code", you have to click on "Apply for Security Code".

Enter the name and e-mail address of the applicant

A security code valid for 24 hours will be sent to the e-mail address. This code can be used to request an EudraCT number.

On the start page, click on "Apply for EudraCT Number" under the 2nd item.

In the input mask, all fields marked with an "*" must be filled in. After clicking on the "Get EudraCT Number" field, the number will be sent to the e-mail address.

The EudraCT Number must also be communicated to the Ethics Committee when the study is submitted. By the end of 2014, more than 42,000 national and international studies had already been entered in the registry, 79% of which were commercial. The trials entered in the EudraCT registry are partially inspected, with more than 500 study sites having been audited or inspected by the end of 2014. These inspections ensure greater transparency and safety for study participants.

Upon entry in the register, key data such as investigational medicinal products, study design, study objective and study sites must be provided. During the course of the study, entries are made, e.g. by the ethics commissions, as well as notes on the completion of a study and any audits / inspections that may have been carried out.

The higher federal authorities (Paul Ehrlich Institute and BfArM) have access to the EudraCT register and, since March 2011, partially to the public, who can gain access to part of the data via the EU Clinical Trials Register. Publicly accessible data are:

• Name of the medicinal product
• Sponsor of the clinical trial
• Study design
• Information on the disease under investigation
• Status of the study (approved, ongoing or completed)

However, the results of the study are not yet publicly available. Likewise, no non-interventional studies or studies with medical devices have yet been entered into the register.