Sweden

DCT Feasibility Assessment Sweden The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Sweden in relation to Decentralized Clinical Trials (“DCTs”). It supplements the regulations applicable to the EU and EEA described in the European M...

2.1 Name of Regulatory Authority Swedish Medical Products Agency/Lakemedelsverket (“MPA”) 2.2 Name of Ethics Committee Swedish Ethical Review Authority/Etikprövningsmyndigheten (“ERA”) 2.3 Clinical Trial Application Language ...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.   The EU Regulation 536/2014 specifies that the documents to be evaluated are divided in...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  The EU Regulation 536/2014 specifies that the documents to be evaluated are divided into ...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   Yes . Details are provided below and can also be found on the MPA website under “ Investigator - suitability and GCP ”. Under Chap...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. Please refer to Section 2.7 of this guidebook. 6.2 Does local regulation require any separate consent for biological specimen collectio...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? Yes . 7.2  Is there any specific regulation/guidance on the use of DCT elemen...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   The following data privacy regulations apply in Sweden: Regulation (EU) 2016/679 - General Data Protection Regulati...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ?   Yes , subject to approval by the Ethics Research Authority. If adve...

10.1 Clinical Trial with Investigational Medicinal Product Prior to commencing a clinical trial, a sponsor must submit a clinical trial authorization application file via CTIS . The EU's new Clinical Trial Regulation (EU) 536/2014 came into f...

Europe EU Clinical Trial Regulation (EU CTR) 536/2014 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014R0536-20220131   EMA- Questions and Answers Document Regulation (EU) 536/2014 https://health.ec.europa.eu/medicina...

None.