Regulatory Affairs
Our offer
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.
Offers for the application of the research consensus
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.
Tips & Support
Would you like to categorise your project yourself?
The categoriser of kofam.ch, the portal of the Federal Office of Public Health (FOPH) on human research, helps you to categorise your research project according to the requirements of the Human Research Act. Categorisation is a necessary step in the application submission.
Would you like to compile and submit the application for approval of your project to the Ethics Committee yourself?
We provide a step-by-step guideline. We will be happy to have someone from the DKF Regulatory Team review your application prior to submission.
Do you need to report adverse events or do you want to include vulnerable subjects in your study?
Here you will find all the information on what to consider in these situations:
Wondering how individuals must give consent when providing their data and samples?
Here you will find an overview of all the regulations:
Free-of-charge for DKF research groups
- Regulatory review of study documents
- Initial submission to Swiss ethics committees and authorities
- Submission of amendments
- Support and management for Data Transfer & User Agreements
- Study registration (applies to all studies at USB)