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.
started January 31, 2022
started May 26, 2021
started May 26 2022
The following will apply when performing a clinical trial/clinical investigation/performance study according to the new regulations:
- The biobank application shall always be submitted at the same time 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: email@example.com
- 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 representative of the biobank of the healthcare principal, and/or head of a Regional Biobank Centre (RBC).
Visit the pages above for specifics regarding each regulation.
Please note, in this general description of clinical trials the term “application” is used and also includes the process concerning MDR and IVDR where a “notification” is made.
Documents and forms
All forms can be found on Biobank Sweden’s document page under the toggle menu called “Research – Documents in English”.
- 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?
- Who shall be the applicant of the biobank application when there is no national coordinating investigator?
- Regarding clinical trials of medicinal products ¬– is there a transition period? Does this instantly cover all clinical trials of medicinal products?
- 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?
There is a transition period. During the first year there are transitional rules, and the sponsor can, until January 31st, 2023, choose to apply for clinical trials of medicinal products according to the new CTR (EU No 536/2014) or according to existing national legislation based on Directive 2001/20/EC. After January 31st, 2023, all applications for clinical trials shall go through the web portal and database CTIS (Clinical Trial Information System) that handles both assessments and questions about considerations.
This means that during the first year, there are two ways to submit your biobank application in connection to a clinical trial of medicinal products depending on what legislation the application for clinical trial follows.
- Application through CTIS: Send the biobank application to firstname.lastname@example.org at the same day as you upload the application for clinical trial to CTIS. All documents can be found at biobanksverige.se/dokument.
- Application that does not go through CTIS: 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 email@example.com 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).
Biobank Sweden can help you with guidance or answer questions regarding how to apply for biobank samples for clinical trials. Contact us at firstname.lastname@example.org. Do this as soon as possible, preferably before beginning your trial to reduce the risk of a delayed start.
The information above is published in 2022. For questions or comments on this page, please contact email@example.com
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