Service Finder
Enter the study in the German Register of Clinical Trials
Service Description
The German Clinical Trials Registry (DRKS) is the primary registry for Germany recognized by the World Health Organization (WHO). It is responsible for all clinical trials that
- were conducted in Germany and
- are patient-oriented.
The aim of the registry is to provide the public with a complete and up-to-date overview of clinical trials in Germany. It contains more than 12,000 studies. Around 2000 are currently added each year.
The DRKS not only serves as a source of information for patients. It also supports experts in the planning of clinical trials. For example, it helps to avoid duplicate studies. The DRKS makes it possible,
- to search for information on ongoing and completed clinical trials in Germany or to make
- make your own studies accessible.
You are responsible for registration as the sponsor or head of the clinical trial of a study.
In Germany, you are not legally obliged to register all trials in a registry. However, physicians responsible for studies are indirectly obliged to register under their professional code of conduct. In addition, various bodies require registration, for example for a
- Funding: groups and organizations such as the Federal Ministry of Education and Research or the German Research Foundation
- Publication: medical journals.
The DRKS does not accept studies with the following criteria:
- no clear clinical reference
- animal experiments
- pure research on tissue without informing the participants and obtaining their signed consent to participate in this study. Exception: COVID studies
- Reviews and meta-analyses
- Pure data collections from patients without a clear clinical reference
You cannot delete a study registered in the DRKS.
Process flow
To register your study in the DRKS, you must use its online portal:
- If necessary, register once.
- Log in to the DRKS online portal with your access data.
- Follow the navigation to register your study.
- Each study is checked for plausibility and completeness.
-
If there are no queries from data management, the study will be registered in the DRKS online portal.
- Otherwise, the person responsible for the study will be asked to edit the study.
- You will receive confirmation of registration by e-mail.
Requirements
Formal criteria:
- Vote of an ethics committee
- individual studies
Further criteria:
- Study on humans or dummies (training dummies). Studies on dummies can be registered in the DRKS, as in this case the object of the study is the medical staff who are to learn something.
- Health-related issues such as disease treatment, therapy monitoring or investigation of risk factors
- interventional studies, for example medication, operations, radiotherapy, consultations, physiotherapy, vaccinations
- Non-interventional studies, for example observational studies, prognosis studies
- Training studies in which people receive training, for example, the effect of which is to be tested. The trained persons should themselves treat patients directly (e.g. studies on doctors, nurses or first aiders)
Which documents are required?
You do not need to submit any documents.
What are the fees?
There are no costs for you.
What deadlines do I have to pay attention to?
You may have to observe deadlines in connection with funding or the publication of your study in scientific journals. The latter requires registration before the planned start of recruitment of the subjects, which is why you should apply for registration at least 3 weeks in advance.
Processing duration
usually a maximum of 2 to 3 working days
Legal basis
Applications / forms
You can withdraw your application until registration has been completed.
Appeal
Forms: no
Online procedure possible: yes
Written form required: no
Personal appearance required: no
Further Information
Author
The text was automatically translated based on the German content.
- German Clinical Trials Registry (DRKS) Registration
Remark: Display of performance in the source portal
Technically approved by
Federal Ministry of Health
Professionally released on
19.08.2021
Source: Zuständigkeitsfinder Thüringen (Linie6PLus)
Start your request directly online:
Competent Authority
Deutsches Register Klinischer Studien (DRKS), Bundesinstitut für Arzneimittel und Medizinprodukte, Dienstsitz Köln
Address
50676 Köln, Stadt