Biobank samples in clinical trials/performance studies
The new EU regulations leads to changed processes when you perform a clinical trial/performance study that includes biobank samples. On this page we explain all you need to know to apply for access to biobank samples in Sweden.
Important information
The following will apply when performing a clinical trial or performance study according to the EU regulations CTR, MDR and IVDR:
- The biobank application must always be submitted at the same day as the application for clinical trial/performance study. For CTR the application needs to be submitted the same day as Part II is submitted
- The biobank application shall always be sent to: kliniskaprovningar@biobanksverige.se
- See our guide: Access to biobank samples in clinical trials and performance studies
Remember:
- The biobank application may only be approved after the clinical trial/ performance study has been approved.
- The biobank agreement is not valid until after the application and any appendices are approved and signed by authorised representatives of the biobank.
Visit the pages above for specifics regarding each regulation.
Please note, in this general description of clinical trials the term “application” is used and includes the process concerning MDR and IVDR where a “notification” is made.
See also:
Documents and forms
Documents and forms
All forms can be found on Biobank Sweden’s document page under the toggle menu called “Clinical trials/performance studies”.
Contact
Biobank Sweden can help you with guidance or answer questions regarding how to apply for biobank samples for clinical trials.
Contact us at kliniskaprovningar@biobanksverige.se. Do this as soon as possible, preferably before beginning your trial to reduce the risk of a delayed start.