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

By law, all prospective clinical trials must be registered in a public register before the project begins. In addition, the University Hospital Basel (USB) has a policy requiring that all prospective research projects, so called observational studies, must also be registered in a public registry. We offer registration as a free-of-charge service for all studies in which the USB acts as the sponsor.

We handle the registration of the study in the ClinicalTrials.gov registry as well as the ongoing maintenance of the study data. The transfer to the Swiss HumRes registry occurs automatically upon submission to a Swiss ethics committee.

Further information (German only)

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.

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.