Conduct of clinical studies during COVID-19 pandemic

Guideline as of 18 Janaury 2021, valid until further notice

This guideline is binding for the University Hospital Basel and was recommended for adoption by the University Children's Hospital Basel, the University Psychiatric Clinics Basel, the Cantonal Hospitals Baselland and Aarau as well as the Felix Platter Hospital, St. Clara Hospital, the University General Practitioners' Centre and the University Dental Clinic.

According to a communication from the Coronavirus Task Force of the University of Basel based on the Federal Council's decisions of 13.1.2021, stricter rules will apply from 18.1.2021. The primary aim of the new rules is to avoid contacts. Therefore, a home office obligation applies where operationally possible.

  • Study conduct in the Outpatient Study Centre (ASZ)
  • Continuation of pathophysiological and phase I studies
  • Inclusions of new participants in intervention and observational studies
  • Start of new studies

The reporting and authorisation requirement for conducting COVID-19 independent studies is not applicable any more.

Research activities in the clinical research groups

1. phase I and pathophysiological studies may be continued, taking into account the conditions listed in paragraph 4. The Outpatient Study Centre (ASZ) at the University Hospital of Basel is available for this purpose.

2. Observational studies with physical patient contact may be continued under consideration of the conditions listed in paragraph 4. The inclusion of new participants is permitted.

3. Patients in therapeutic intervention studies may also be treated under consideration of the conditions listed in paragraph 4. The inclusion of new participants and the start of new studies is possible.

4. Conditions for the continuation of studies:

  • The risk of infection and the spread of the virus must be limited by the following measures: All activities in the Outpatient Study Centre and patient contacts during outpatient study visits must be in accordance with the USB guidelines for the conduct of patient consultations during the COVID-19 pandemic (see relevant directives from the Directorate).
    These include, among others:

    • Hygiene measures: Regular hand washing/disinfection, continuous wearing of a type II/IIR mouth/nose protection (except when working in a single office), etc.

    • Distance rules: 1.5 m distance, groups up to max. 5 persons, max. 1 patient/healthy voluteer per room in the Outpatient Study Centre (ASZ)

    • The patient/healthy volunteer should also wear a type II/IIR mouth/nose protection, if possible.

    • These hygiene measures also apply during breaks.

    • In order to be able to trace and narrow down potential infections, the following rules also apply:

      • Traceability: Contacts between participants and study personnel, as well as between study personnel, must be documented in such a way that they can be traced retrospectively

      • Limitation: Study contacts between patients and study staff must be limited so that there is as little overlap as possible between different patients and staff.

  • The current hospital instructions and hygiene guidelines for handling COVID-19 must be followed by all study staff.

5. studies on COVID-19:

Different rules may apply to research groups at hospitals other than the University Hospital Basel. Please contact the responsible decision-maker at your hospital.