IMPORTANT INFORMATION:
clinicaltrials.gov currently not served
New registrations of studies and updates of existing registrations in the portal clinicaltrials.gov are currently not possible due to the US budget freeze (government shutdown).
However, interventional clinical trials in accordance with ClinO (Art. 64) must be registered in a WHO primary registry before the start of the trial and within 6 months of approval. Researchers can switch to one of these registries for such studies.
Human Research Switzerland recommends ISRCTN (UK) and DRKS (Germany) in particular. However, registration in a portal other than clinicaltrials.gov must be done by the researchers themselves and cannot be taken over by the DKF for licensing reasons.
If you register a study for which the University Hospital Basel is the sponsoring institution in one of these portals, please inform us at registration.dkf@clutterusb.ch. We will additionally register your study on clinicaltrials.gov as soon as this is possible again.
Information from Human Research SwitzerlandRegulatory Affairs
Our offer
Project categorisation
The category of your project according to the applicable regulatory framework determines the approval and notification requirements you must fulfill. We guide you with this categorisation and help you to find out which further steps are needed. We consider the Swiss Human Research Act HRA as well as European laws like the Clinical Trials Regulation CTR and the Medical Device Regulation MDR.
Study documents
We review all study documents on formal aspects (regulatory review). We can provide support in writing patient information and obtaining insurance certificates. We also offer support in writing country- and centre-specific addenda and in implementing amendments to the study protocol.
Contracts
The contracts required for the timely conduct of clinical trials and human research projects are diverse and complex. We support you with the appropriate templates, with the wording and with the review by involved parties involved and your legal services.
Regulatory approvals
We compile all documents for the application to ethics committees and Swissmedic and handle the entire submission, including communication with the authorities. We also manage submissions abroad and support you in reporting multicentre studies in the Clinical Trial Information System CTIS and in Eudra Vigilance.
Study registration
All prospective clinical trials at the University Hospital Basel (USB) have to be registered in a public registry before they start. We take care of the registration of your study in the study registries Human Research Switzerland HumRes and clinicaltrials.gov and we manage the ongoing maintenance of the study data in the respective registry.
Amendments
We report changes in the study protocol or in other documents to the authorities as amendments. If necessary, we take care of obtaining new approvals.
Safety & Progress Reports
We provide you with an overview of reporting requirements (e.g. SUSARs or safety and protective measures) and the deadlines to be met. Also, we take care of forwarding them to the ethics committees and competent authorities. We prepare annual safety and general progress reports in collaboration with you and ensure that they get submitted.
Deregistration of the study and final documentation
After completion of your research project, we take care of all necessary documentation and properly deregister the project. We also prepare a Clinical Study Report if requested.
Information for the application of the research consensus
In order to be allowed to use health-related data and samples that arise in routine clinical practice for research, the consent of the patients concerned is required. Here you will find further information on the processes around the research consent at the University Hospital Basel.
Useful links
- Swiss Agency for Therapeutic Products
Swissmedic - Swiss Association of Research Ethics Committees
swissethics - Business Administration System for Ethics Committees
BASEC - Human Research Switzerland
HumRes - European Medicines Agency
EMA - EudraVigilance
- Clinical Trial Information System
CTIS - clinicaltrials.gov
Relevant laws & regulations
- Regulatory support for up to 10 hours free of charge (starting with a review of the documents and, if there is sufficient time, continuing until submission to the ethics committee or authority (Swissmedic))
- Study registration (applies to all USB-sponsored studies)
Further information