FAQ: Frequently asked questions


What is DRKS?
What are the advantages of DRKS?
Why should clinical trials be registered?
Is it legally required to register clinical trials in Germany?
What is ICMJE?
Does the DRKS meet ICMJE criteria?
Is there a fee for the use of the register or the registration?
Who is responsible for the registration of a clinical trial?
Which trials can/should be registered with DRKS?
Where is it possible to register systematic reviews?
At which time point should clinical trials be registered?
Is ist possible to register trials which are already ongoing or finished (retrospective registration)?
The activating link/password reset does not work
Modifications in the course of the data import from ClinicalTrials.gov

What is DRKS?

The DRKS is the German WHO primary registry and is competent for the registration of all clinical trials conducted in Germany. Our aim is to offer a complete topical overview of all trials conducted in Germany and thus providing a contact point for clinical trials in Germany.
The DRKS is a non-profit organization and is located at the German Institute of Medical Documentation and Information (DIMDI). DIMDI is a governmental institution within the scope of the Federal Ministry of Health (BMG).

What are the advantages of DRKS?

Both searching for clinical trials and registering new trials is free. The entry mask is available in both German and English and was designed in a very user-friendly way. Most of the parameters can be filled in with drop-down menus using standards, catalogues and (internationally) used codes like identification key ICD-10. These standardisations make entering data and data exchange easier and are furthermore the prerequisite for automatic plausibility and validity checks and descriptive statistical evaluation. Possible answers are recorded in both English and German to obtain a bilingual registry. We tried to avoid free text slots as far as possible.
Furthermore participation in trials is facilitated, as patients and their treating physicians can find information on on-going trials in DRKS.

Why should clinical trials be registered?

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 as they 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 completely missed publication of a trial which had unwanted or supposedly uninteresting outcomes 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 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."

Is it legally required to register clinical trials in Germany?

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

What is ICMJE?

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 (http://www.icmje.org/publishing_10register.html). Over 700 medical journals joined this union (http://www.icmje.org/journals.html).

Does the DRKS meet ICMJE criteria?

Yes. ICMJE accepts registration in all primary registries of the WHO network. The DRKS is accepted as primary registry for Germany by the WHO since 2008 and thus meets the requirements of the International Committee of Medical Journal Editors (ICMJE).

Is there a fee for the use of the register or the registration?

No. Both registration and searching for trials is free.

Who is responsible for the registration of a clinical trial?

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

Which trials can/should be registered with DRKS?

All trials that include patients in Germany should be registered at DRKS. The DRKS, however, also accepts trials that are conducted in other countries.

Worldwide, there are a lot of claims that not only interventional clinical trials should be registered but also observational and prognosis studies. The Lancet encourages the registration of all observational studies on a WHO-compliant registry (Lancet 2010; 375: 348). In the registry network of the WHO, an expansion of the registration which goes beyond the classical definition of a clinical trial (see below) is extensively discussed. The need of an observational studies register was also described in 2010 by Swaen in the Journal of Clinical Epidemiology (64 (5), p.481-486).

We would, therefore, like to invite you to register all trials (including interventional clinical trials but also observational and prognosis studies with the aim to gain knowledge on a disease or health problems of participants) at DRKS.

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

WHO definition of a clinical trial: "For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials."

Where is it possible to register systematic reviews??

The "International Prospective Register for Systematic Reviews PROSPERO" is open for free registration to anyone undertaking a systematic review with a health-related outcome. See http://www.crd.york.ac.uk/prospero/ for more information.

Further information: The PLoS Medicine Editors (2011) Best Practice in Systematic Reviews: The Importance of Protocols and Registration. PLoS Med 8(2): e1001009. doi:10.1371/journal.pmed.1001009 http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001009

At which time point should clinical trials be registered?

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), i.e. before the first participant signed the written informed consent. All trials registered after recruiting the first participant are considered to be retrospective and are not conform to the ICMJE principles.

Please bear in mind that a trial can only be registered after routine automatic and manual checks on validity and completeness and, therefore, will not be publicly visible until after these checks. We know from experience that generally some queries have to be answered. So please plan enough time (at least several days in which you are accessible and can make necessary changes) for the registration process.

Is ist possible to register trials which are already ongoing or finished (retrospective registration)?

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

The activating link/password reset does not work

If the activating link for you account does not work or if you are not able to reset your password please get in touch with the data management team (kontakt-drks@dimdi.de).

Modifications in the course of the data import from ClinicalTrials.gov

The DRKS also imports trials from other registers to avoid duplication of work and for a full picture of the study situation in Germany. Here you can find an overview of the required adjustments in the course of the data import from ClinicalTrials.gov.

Last Modified: 07-05-2017