Regulatory Affairs

We advise and support you in all regulatory matters concerning your research project.


Our competencies

  • We are familiar with national and international legal regulations for human research and know which framework conditions must be adhered to in academic research.

  • We maintain regular cooperation and exchange with the competent authorities and abroad and are thus always up to date with the latest developments.

  • We advise and support a wide variety of clinical studies and research projects and continuously pass on our experience.

  • We have years of experience in the uniform classification of adverse drug events and adverse drug reactions according to the internationally recognized MedDRA® terminology.

    Our services

    in the course of a clinical research project

    Study phases

    Typical phases of a clinical research project

    CONCEPT phase

    Project categorisation
    One of the many clarifications that must be obtained in the early phase of a clinical research project is to determine which category your project falls into under Swiss human research law. Approval and reporting obligations for your project depend on this categorisation.

    We help you with this categorisation and the definition of the steps to be derived with regard to regulatory affairs.


    PLANNING Phase

    In this phase, numerous preparations must be made for a successful start of the study. In order to obtain approval for your project, a number of clarifications and the preparation of various documents are required. We offer support with:

    • Regulatory review of all study documents (checking for formal aspects)

    • Preparation of patient information

    • Submission to ethics committees and Swissmedic, including handling of all communication. We also handle submissions abroad.

    • Study registration and maintenance of the contents in the study registries (Swiss National Trials Portal (SNCTP) and ClinicalTrial.gov)

    • Obtaining the insurance certificate
    [Translate to English:] Bettina & Emilie

    Study registration at the USB

    Increating transparency


    CONDUCT phase

    Amendments
    While a research project is underway, changes in the study protocol or other documents may occur.

    We take care of submission these amendments and, if necessary, obtain re-approvals.

    Safety Reports
    We provide help with the preparation of the Annual Safety Reports for you and take care of the timely reporting to the Ethics Committees and other authorities.

    MedDRA coding
    MedDRA (Medical Dictionary for Regulatory Activities) is the basis for electronic data exchange and enables internationally uniform communication. The coding of data according to MedDRA terminology is increasingly used by regulatory authorities, pharmaceutical companies, clinical research organizations and in the healthcare sector, for example in the documentation and monitoring of drug or medical device safety.

    We provide support for the MedDRA coding of your safety data in the context of data management and in the preparation of study reports.


    COMPLETION phase

    Close out & final documentation
    After completion of your research project, we will take care of all necessary documentation and deregister the project correctly.


    Application of the General Consent

    Support in the implementation of the general 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. The processes for implementation of this General Consent at the University Hospital Basel have been established by the DKF. If you have any questions or need support in implementing the General Consent in your department, we will be happy to assist you.

    [Translate to English:] Unterschrift

    More information & documents

    General Consent

    Obtaining health-related data for research projects

    We provide you with access to relevant patient data that is generated in the hospital's routine clinical operations. Requests for research projects that fall under the Human Research Act can be made online using our contact form.