International Networking


The DRKS meets the requirements of the ICMJE

The DRKS is the approved WHO Primary Register in Germany and thus meets the requirements of the International Committee of Medical Journal Editors (ICMJE). This committee which is a union of the publishers of the leading international medical journals (amongst others The Lancet, JAMA, NEJM) demands the prospective registration of clinical trials as requirement for any publication (recommendations). Numerous further medical journals support this call (http://www.icmje.org/journals.html).

The DRKS in the WHO network

The DRKS is designed in close collaboration with the WHO. The WHO brings together the worldwide activities for the registration of clinical trials on the International Clinical Trials Registry Platform ICTRP (http://www.who.int/ictrp/en/). Its purpose is to allow exchange and to link and develop trial registers worldwide. That means e.g. standardisation of processes to get harmonised data collection and ensure consistent data quality. As a Primary Register, the DRKS is a member of the ICTRP network.

Global search for clinical trials

In order to enable a global search for clinical trials the WHO started a Meta register in May 2007 in which all registers involved bring their data together (http://apps.who.int/trialsearch). A list of the involved registers can be found under http://www.who.int/ictrp/network/primary/en/index.html).

Primary Registry: requirements

The consultation and coordination process of the last years lead to a development and arrangement of the minimal dataset of twenty parameters. Clinical trial registers have next to other requirements to collect at least the data of these parameters and submit it to the WHO in the English language to become an approved Primary Registry of the WHO. For independency and transparency reasons, Primary Registries have to be lead by an independent institution or organization. They have to be free and publicly accessible and have to have a governmental endorsement. Hereby, the WHO wants to ensure that only one registry of each country is allowed to submit data to the WHO portal and furthermore demands national legitimating and support for the trial registry. The DRKS in Germany meets all these requirements and therefore became approved Primary Registry in October 2008.

Last Modified: 09-30-2014