Biobank samples in clinical trials/performance studies

All forms can be found on Biobank Sweden’s document page under the toggle menu called “Research – Documents in English”.

1. What about studies that only have private healthcare providers with biobanks of their own? Can private healthcare providers assign an RBC to handle biobank applications and give a statement of opinion?
2. Who shall be the applicant of the biobank application when there is no national coordinating investigator?
3. Regarding clinical trials of medicinal products ¬– is there a transition period? Does this instantly cover all clinical trials of medicinal products?
4. How does the regulations for clinical investigation of medical devices (MDR) and performance studies of in vitro diagnostic devices (IVDR) differ to the regulation for clinical trials of medicinal products (CTR) regarding how the biobank application shall be submitted for assessment?

1. What about studies that only have private healthcare providers with biobanks of their own? Can private healthcare providers assign an RBC to handle biobank applications and give a statement of opinion?

No, the process is, at present, applicable for regional biobanks that have assigned a RBC to handle and give their statement of opinion on these biobank applications.

2. Who shall be the applicant of the biobank application when there is no national coordinating investigator?

The applicant of the biobank application shall be the sponsor (or authorised representative of the sponsor), i.e., same applicant as in the application for clinical trial/ performance study.

If samples shall be sent abroad for analyses, a Swedish research institution needs to be responsible for the samples according to the Biobanks in Medical Care Act. This means that the applicant needs to be active in Sweden. The applicant shall also be the one signing the application. Feel free to contact us at an early stage in the process for guidance in your specific case.

3. Regarding clinical trials of medicinal products – is there a transition period? Does this instantly cover all clinical trials of medicinal products?

From January 31 2023, it is no longer possible to apply according to the old directive (2001/20/EC)/national legislation. If you already have an ethical approval – apply for access to samples with document N1a/N1b for biobank application according to multicenter principle with newly collected samples or L1 and potential attachments if not according to multicenter principle.

Send the biobank application to concerned RBC or biobank in the same way as before. This assuming that separate applications have been sent to the Swedish Medical Products Agency and to the Swedish Ethical Review Authority and not been uploaded to CTIS.

4. How does the regulations for clinical investigation of medical devices (MDR) and performance studies of in vitro diagnostic devices (IVDR) differ to the regulation for clinical trials of medicinal products (CTR) regarding how the biobank application shall be submitted for assessment?

The process does not differ. The biobank application shall be sent to kliniskaprovningar@biobanksverige.se at the same time as the application for clinical trial/clinical investigation/performance study regardless of which regulation.

Information about clinical trials, clinical investigations and performance studies and the different requirements and application processes for CTR, MDR, and IVDR can be found at the Swedish Medical Products Agency – Clinical investigation of medical devices | Swedish Medical Products Agency (lakemedelsverket.se).