Things to consider when applying for access to biobank samples
On this page, we have compiled information that may be important for you when applying for access to biobank samples in a clinical trial or performance study under the EU regulations (CTR, MDR, IVDR). The guide applies to situations in which a regional biobank is involved in the process.
For the Regional Biobank Centre (RBC) to be able to handle your biobank application in parallel with the clinical trial application, you must always submit your biobank application on the same day that you submit:
- The application for clinical trial of medicinal products (Part II)
- The application for clinical trial or performance study of a medical device
- The application for a substantial modification of the above if the modification affects the biobank agreement
The biobank application must be sent to kliniskaprovningar@biobanksverige.se for the RBC to be able to process it.
Important to provide feedback to the RBC in case of comments
For your application to be approved, you must respond to any considerations from the RBC and the pathologist conducting the feasibility assessment before the specified date. Responses may be provided via an updated application or through clear justification.
If considerations remain, your application may be delayed or rejected.
If the application concerns access to pathology/cytology samples
If you plan to request access to clinical pathology or cytology samples for your study, it is important to prepare your application at an early stage. A request for these samples may require prioritizing the analyses within the study, particularly in case there is a limited amount of material remaining after diagnostic analyses.
If this is not sorted out before applying, approval of the biobank application may be delayed.
Important aspects to consider:
- The contact person representing the sponsor should have relevant expertise and good knowledge of the study design regarding samples and sample handling.
- Find out which services are available within the different regions; visit Biobank Sweden’s service catalogue for guidance (available in Swedish only).
- Contact the relevant regions through the Network for Study Coordinators in Clinical Pathology if:
- Study-specific tissue samples are to be collected and/or handled by clinical pathology.
- A participating pathologist needs to be specified in the application (applies to certain regions).
- Use form L1a to request access to clinical pathology or cytology samples taken for healthcare purposes.
- It is of utmost importance that you specify both:
- Requested quantity (field 6.2.2 in form L1a): amount of material needed to perform the planned analyses of the study.
- Minimum quantity (field 6.2.5 in form L1a): the minimum amount of material that still makes the study feasible. If the requested quantity is unavailable, it is important to have a clear priority regarding the critical analyses needed to conduct the study, while ensuring that the patient is not excluded.
About signing
Notify the RBC as early as during the reviewing process of any requests for digital signing.
In cases of wet ink signature, submit the application as soon as possible after the RBC has sent out its final report (form TY5) with instructions.
The following always applies when applying for biobank samples for clinical trials or performance studies
- The biobank application can only be approved once the clinical trial or performance study has been approved
- The biobank agreement enters into force only when the application and appendices have been approved and signed by an authorised representative of the biobank.
- The term “application” also includes MDR/IVDR processes in which a “notification” is made.