The German Clinical Trials Registry (DRKS) is the WHO-recognised primary registry for Germany and, along with CTIS, is responsible for the registration of patient-oriented clinical trials conducted in Germany. Further information can be found on the homepage and the item "About us".

The goals of the DRKS can be found in our "About Us" section.

Clinical trial registries increase the transparency in clinical research because they provide public access to trial data. They serve as a source of information for patients and support the expert audience in the planning of clinical trials e.g. by helping to avoid redundant trials.

People conducting clinical trials have the responsibility towards patients, sponsors, colleagues and the public in general to publish their outcomes. A delayed or completely missed publication of a trial which had unwanted or supposedly uninteresting outcomes (“under-reporting”) as well as the rapid and repeated publication of desired results can lead to a severe bias. Possible consequences are overemphasis of the benefits of a therapy and at the same time disregard of potential risks. Complete registries of clinical trials are one important component to avoid under-reporting as they prove the existence of a trial in form of a "birth certificate" and thus prevent the disappearance of a trial.

The World Medical Association demands in the Declaration of Helsinki (version 2008) in paragraph 19: "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject."

The DRKS is the only study registry for Germany recognised by the WHO and collects study data in German and English. Patients and other interested laypersons can better use and understand entries in their national language. Information provided in German can thus improve recruitment in a study, as patients can more easily find information about the study. By registering a study in both languages in the DRKS, the greatest possible transparency for the German public regarding clinical trials is achieved.

It should be noted that clinical trials with medicinal products from Germany and other EU countries must be registered in the WHO-recognised Clinical Trials Information System (CTIS) of the EU.

In addition to the DRKS, there are two other registries that contain a significant number of studies conducted in Germany. Their studies are mostly not included in the DRKS (see FAQ below).

• EU-CTR/CTIS: Approximately 600 phase II-IV drug trials (as of 2022) were registered and published in the EU-CTR (EudraCT) per year until 01/2023. Since 02/2023 they have to be registered and published in the CTIS public portal. Phase I studies are only included if they are clinical trials with paediatric medicinal products or clinical trials as part of a paediatric investigation plan (PIP).
• Clinical.Trials.gov: Approximately 1300 in Germany conducted studies per year are registered here (as of 2023). Most of these are internationally conducted studies for which Germany is only one of many sites.

WHO recommends that clinical trials with one or more recruitment sites in the same country should be registered in only one study registry.
If there are several recruitment sites in different countries, the trial can be registered in more than one registry if this is necessary to meet the ethical, legal or other requirements of each country. As a matter of principle, however, trials should only be included in more than one registry if it is absolutely necessary.

For more information, please visit the WHO website.

CTIS has been an official "Data Provider" of the ICTRP registry of the WHO since June 2023 and is thus recognised by the ICMJE equivalent to ClinicalTrials.gov. Studies from CTIS should therefore only be registered in the DRKS with appropriate justification (see previous FAQ).

Formal criteria:

• the existence of a vote by an Ethics Committee of the European Union or Switzerland in German or English. Votes in other languages require an official translation in addition.

Additional criteria:

• study on humans
• health issues such as disease treatment, therapy monitoring, healthcare research or investigation of risk factors
• interventional studies (e.g. medication, operations, radiation, talks, physiotherapy, vaccinations)
• non-interventional studies (e.g. observational studies, prognosis studies, epidemiological studies)
• training studies are studies, in which people receive training or similar whose effect is to be tested. The trained persons should directly treat patients themselves (e.g. studies on doctors, nurses, first aiders, etc.)

Which studies are not registered with DRKS?

• studies without clear clinical reference
• animal experiments
• reviews and meta-analyses
• studies evaluated in Germany by a private, commercial ethics committee

If you are unsure please contact the DRKS team before registration.

Disclaimer:

If your study does not meet one of the above criteria, you can still register the study if the medical journal in which you may wish to publish your study requires (prospective) registration in a public registry.

A study cannot be registered without a positive vote by an ethics committee. This must be submitted in German or English.

If the vote is not in German or English, an official translation must be included.

No. In Germany, in contrast to other countries like e.g. the US, there is no legal requirement to register clinical trials. Various groups and organisations like research funding institutions (BMBF, DFG and other) and most of the leading medical journals (q.v. "What is ICMJE?") demand the registration of clinical trials as prerequisite for funding or publication and thus create a certain pressure.

Research-based physicians are obliged by their professional code of conduct to observe the Declaration of Helsinki. In the currently valid version of 2013, §35 states: "Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.” Therefore, please check (if necessary together with the responsible ethics committee) whether you need to register your study in a publicly accessible study register (such as DRKS).

In order to register a trial according to ICMJE standards, it has to be registered in a registry accepted by the ICMJE before recruiting the first participant (=prospective registration). A participant is considered as recruited as soon as the patient consent form was signed. All trials registered after recruiting the first participant are considered to be retrospective and are not conform to the ICMJE principles.

The Declaration of Helsinki, §35, requires: Every research project involving subjects must be registered in a publicly accessible database before the first subject is recruited.

Please bear in mind that the data submitted is routinely checked by DRKS data management. Usually queries of the data management must be answered before registration and thus publication of the data may take some time. If possible, allow 3 weeks for the registration process, because the registration date corresponds to the time of publication and not to the time of the first transmission of the data.

The sponsor is responsible for the registration. The task can, however, also be delegated (e.g. to the Principle Investigator/ Lead Principle Investigator).

Yes, you can also register ongoing and finished trials. However, this retrospective registration does not meet the standards of ICMJE and might not be accepted by all journals. Retrospectively registered trials are clearly marked as such in the DRKS.

No. The DRKS is the primary registry for Germany recognised by the WHO and is bound by the WHO's international standards for clinical trial registries. It stipulates in section 1.5 that once a study has been registered, it may never be deleted.

WHO Standards

No. Both registration and searching for trials is free.

The International Committee of Medical Journal Editors (ICMJE) is a union of the publishers of leading international medical journals which set guidelines for the publication of clinical trials. The ICMJE includes journals like JAMA, New England Journal of Medicine and The Lancet. It demands the prospective registration of clinical trials as requirement for a publication.

Over 8000 medical journals joined this union (as of 2023).

List of journals

Yes. The ICMJE accepts registration in all primary registries and data provider registries of the WHO network. The DRKS has been recognised by the WHO as a primary register for Germany since October 2008 and thus fulfils the requirements of the ICMJE. A listing of the WHO registers can be found on the ICTRP registry network.

The "International Prospective Register for Systematic Reviews PROSPERO" is open for free registration to anyone undertaking a systematic review with a health-related outcome.

Article on the subject: Best Practice in Systematic Reviews: The Importance of Protocols and Registration

If the activation link for you account does not work or if you are not able to reset your password please contact the technical helpdesk of the BfArM (helpdesk-technik@bfarm.de).

The SearchTool is updated every night. You can access your study directly after registration via the direct link (www.drks.de/DRKS000XXXXX) or find it via the Search Tool as of the next day.

Studies automatically imported from ClinicalTrials.gov until June 30, 2017, were removed from the database with the transition to the new DRKS application at the end of 2022. Duplicate registration in multiple WHO primary registries is not desired by WHO. Also, the studies were no longer maintained and thus became outdated in the DRKS. The original and current study entries can still be found in the registry of origin ClinicalTrials.gov. A list of the affected studies can be found here: List of ClinicalTrials.gov studies not migrated to the new DRKS system

IST/IIT stands for investigator sponsored trial/investigator initiated trial. The responsibility for initiation and organisation of such a study (the sponsorship) rests with the respective individual or the institution to which this person belongs (e.g. university, hospital, public institute, non-profit organisation, patient organisation). The objective is a gain in scientific knowledge.

In contrast, commercial trials intend to generate future profits or cost savings. The sponsorship normally rests with a private business (e.g. a pharmaceutical company) but can also apply to a study financed in whole or partly from public funds.

In conclusion, a study, which is e.g. organized and financed by a public health insurance, can only be accounted to an IST/IIT, if there is no commercial interest.