Online course on clinical trials and performance studies now available in English

Biobank Sweden’s online course on applying for access to biobank samples for clinical trials and performance studies is now available in English. The English version is intended to make it easier for international sponsors and other stakeholders to understand the Swedish process when applying for access to biobank samples.

Following changes to EU regulations governing clinical trials, performance studies and medical devices, Biobank Sweden developed a separate process that enables biobank applications to be reviewed in parallel.

The EU regulations CTR, IVDR and MDR apply throughout the EU, but national requirements and procedures are important to be aware of when applying for access to biobank samples in Sweden. When the new regulations came into force, Biobank Sweden published information about the application process. This information later evolved into a digital e-course.

The English online course Biobank Applications – Clinical Trials and Performance Studies, is a translation of the existing Swedish course. It provides information about the requirements regarding biobank applications in Sweden, including the forms and documents used by Biobank Sweden, both as part of the application process and as guidance to applicants.

– We have seen an increased demand for information in English. To meet this need, Biobank Sweden’s Education Working Group decided to translate the existing course on clinical trials and performance studies. It is a relatively quick solution that we hope will make the process easier for applicants. If this proves successful, we are already planning additional translations and courses in English, explains Linda Paavilainen, who is responsible for Biobank Sweden’s Education Working Group.

The new course includes the following learning objectives:

• Understand the application process for clinical trials and performance studies (CTR, IVDR, MDR) that involve biobank samples 
• Be aware of the key considerations when applying for access to biobank samples 
• Be familiar with current documents and forms issued by Biobank Sweden 

The online course is available on Biobank Sweden’s learning platform