FAQ: Frequently asked questions


What is DRKS?
What are the advantages of DRKS?
Why should clinical trials be registered?
Why should a study be registered with the DRKS?
Do I have to enter a study twice if it is already registered in ClincialTrials.gov but I would also like an entry in the DRKS?

Is it legally required to register clinical trials in Germany?

What is ICMJE?

Does the DRKS meet ICMJE criteria?
When is a study correctly registered according to 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)?
Can a study once registered in the DRKS be deleted from the register?
The activating link/password reset does not work
Can I see and use the closed area for test purposes?
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."

Why should a study be registered with the DRKS?

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

Do I have to enter a study twice if it is already registered in ClincialTrials.gov but I would also like an entry in the DRKS?

Studies that are already registered in ClincialTrials.gov can be transferred to the DRKS system through the DRKS data management if desired. In the DRKS, you then only have to add a few German free text fields, which results in little additional effort. If you would like this procedure for a study you have registered in ClincialTrials.gov, please contact the DRKS staff.

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.

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).

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).

 

When is a study correctly registered according to ICMJE criteria?

The International Committee of Medical Journal Editors ICMJE requires prospective registration (prior to inclusion of the first patient) of the study in order to accept a publication. Please note that a study is only correctly registered if the automatic and manual checks for validity and completeness have been successfully completed and the study has been registered by the DRKS data management (identifiable by the publication on the DRKS homepage under the DRKS ID). Only the creation of a "New Study" in the DRKS does not generate an ICMJE- compliant registration.

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?

Formal criteria:

Additional criteria:

Which studies are not registered with DRKS?

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

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. Since this takes time on our side as well as on yours, please plan enough time for the whole registration process (if possible about 3 weeks in which you can be reached and make necessary changes). Ideally, you should start the registration process as soon as you have the positive ethics vote.

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.

Can a study once registered in the DRKS be deleted from the register?

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 that once a study has been registered, it may never be deleted.

WHO- Standards (PDF, 803 kB)

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 (datenmanagement@bfarm.de).

Can I see and use the closed area for test purposes?

To register and edit studies, you must be a registered user and create a personal user account to gain access to the closed area of the portal.

If you only want to test the closed area, please use the demonstration environment. This is a separate application with the full functionality of the actual register.
You can save and edit your entered study data in the demonstration environment.

However, it is not possible to register the studies entered here in the DRKS portal.

You can use the demonstration environment as a demo user or create an individual test user account.

Demo user
If you want to get a quick overview, you can use our preconfigured access as a demo user.

Please note that any data you enter as a demo user will also be visible to other users who log in as a demo user. Furthermore, the data collected in the test environment will be cleaned by us at regular intervals and the initial state will be restored.

Please use the following access data:
Username: demouser
Password: demouser

Login demonstration environment

Individual test user account
You can create an individual user account.

Please note, the data collected in the test environment will be cleaned by us at regular intervals and the initial state will be restored.

User Registration Demonstration Environment

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

Until 30 June 2017, studies from other registers were also imported for cooperation partners, for example. Adjustments were necessary for studies imported from ClinicalTrials. gov. You can still see an overview of these adjustments here.

Last Modified: 10-12-2020
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