Project categorisation

The category according to the Swiss Human Research Act (HRA) of your project determines the approval and notification requirements you must fulfill. We help you with this categorisation and help you to find out which further steps are needed.

Study documents

We offer support in writing patient information sheets and obtaining insurance certificates. We also review all study documents for formal aspects (regulatory review).

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 handle submissions abroad and provide support with access to and registration of your multicentre study in Clinical Trial Information System (CTIS).

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 Swiss National Trials Portal (SNCTP) and ClinicalTrials.gov and 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 Reports

We prepare the annual safety reports for you and ensure that they are forwarded to the ethics committees and other authorities on time.

Pharmacovigilance and MedDRA coding.

Our "Medical Monitoring" includes the medical assessment of the study protocol for feasibility and a pre-trial risk analysis. We review the AEs/SAEs documented in the (e)CRF and make the medical interpretation of the data in exchange with the investigators. In addition, we can take over the coding of the safety reports according to the MedDRA terminology.

By collecting, processing and archiving relevant safety information, we guarantee the individual monitoring of patient safety in your study. On request, we also write reports and documents for sponsors and authorities.

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.

Support in the implementation of the research consent

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. This consent process, called research consent, is the responsibility of the DKF at the University Hospital Basel. If you have questions or need support regarding the implementation of the research consent in your department or in general, we will be happy to assist you.

Obtaining health-related data for research projects

We provide you with access to relevant patient data generated in the hospital's routine clinical operations. You can make corresponding requests for research projects that fall under the Human Research Act easily and online via our contact form.