Application
Once the research plan is complete, you must apply for approval from the Swedish Ethical Review Authority and, in many cases, also for authorisation from the Swedish Medical Products Agency.
- Apply for the approvals required for your clinical study
- Apply for ethical review
- If the study will also be reviewed by the Swedish Medical Products Agency
- Studies in which participants are exposed to ionising radiation
- Apply for access to biobank samples
- Handle personal data correctly
- Register the study before it begins
- National agreement on clinical studies
- Use templates and supporting documents
- Specific requirements for medicinal products and medical devices
- Applying for authorisation for a clinical trial of a medicinal product
- Applying for a clinical investigation of a medical device
- Applying for a performance study of an in vitro diagnostic medical device
- Related information about Advanced therapy medicinal products (ATMPs)
- Advanced therapy medicinal products (ATMPs)
Apply for the approvals required for your clinical study
The application process is easier if you have prepared thoroughly and developed a clear research plan.
Once the preparations are complete, you must apply for ethical review by the Swedish Ethical Review Authority. In many cases, you will also need to apply for authorisation from the Swedish Medical Products Agency.
Apply for ethical review
You need to apply for ethical review by the Swedish Ethical Review Authority if your research involves:
- studies of living or deceased persons
- the use of biological material from humans
- the processing of sensitive personal data
To prepare a good application, it is important to understand the principles of ethical review.
Requirements under the Ethical Review Act
Research may only be approved if it:
- is conducted with respect for human dignity
- takes human rights and fundamental freedoms into account
- gives priority to the welfare of individuals over the interests of society and research
- involves risks that are reasonable in relation to the scientific value of the research
- is conducted by, or under the supervision of, a researcher with sufficient expertise
The Declaration of Helsinki provides further information about research ethics in clinical research.
Research ethics in medical research, Declaration of Helsinki External link.
Before submitting your application
Applications for ethical review are submitted through the Swedish Ethical Review Authority’s website.
An application will only begin to be reviewed once it is complete. This means that:
- the application form has been completed correctly
- the fee has been paid
- all requested information has been enclosed.
The processing time is approximately 60 days.
Further information is available on the Swedish Ethical Review Authority’s website.
- Information about the Ethical Review Act, the Swedish Ethical Review Authority External link.
- Ethical review – how it works, Swedish Ethical Review Authority website External link.
- Application for ethical review and guidance on the research plan, Swedish Ethical Review Authority website External link.
- Frequently asked questions about applications, Swedish Ethical Review Authority website External link.
- Information for study participants, Swedish Ethical Review Authority website External link.
- Ethical review fees, Swedish Ethical Review Authority website External link.
If the study will also be reviewed by the Swedish Medical Products Agency
If the study requires authorisation from the Swedish Medical Products Agency, the ethical review process is affected by the EU regulations governing clinical trials of medicinal products and clinical investigations of medical devices.
Find out which requirements apply to your study under Specific requirements for medicinal products and medical devices further down this page.
Studies in which participants are exposed to ionising radiation
Specific provisions apply to medical exposure to ionising radiation, such as X-ray examinations. These provisions apply to clinical studies in which participants are exposed to ionising radiation.
The Swedish Biobank Act applies to human biological samples that:
- are to be preserved
- can be linked to a specific donor.
Biobank samples may have been collected for healthcare, diagnostics and treatment or for clinical research. A biobank sample may consist of:
- blood, serum, plasma or saliva
- faecal samples
- tissue samples such as biopsies, tumours or organs.
Samples covered by the Swedish Biobank Act and collected in Sweden must always be held in a Swedish biobank.
Apply for access to biobank samples
The Biobank Act covers human biological samples that:
- are to be stored
- can be linked to a specific donor
Biobank samples may have been collected for healthcare, diagnostics and treatment, or for clinical research. A biobank sample may consist of:
- blood, serum, plasma or saliva
- faecal samples
- tissue samples such as biopsies, tumours and organs
Samples covered by the Biobank Act that are collected in Sweden must always be stored in a Swedish biobank.
When is a biobank application required?
The agreements required to conduct research using biobank samples depend on:
- how the study is designed
- which biobank is responsible for the samples.
An approved biobank application is often required before the study can begin.
How to apply
When biological samples are to be collected, approval from the Swedish Ethical Review Authority or authorisation under the relevant EU regulations governing clinical trials and performance studies is required. This applies regardless of whether the samples are covered by the Swedish Biobank Act.
Submit the biobank application to the regional biobank coordinator or a Regional Biobank Centre (RBC). They can also provide advice about matters such as information for study participants and relevant parts of the ethical review application.
The EU regulations governing clinical trials of medicinal products and clinical investigations of medical devices also affect the biobank application process. Further information is available under Specific requirements for medicinal products and medical devices.
Biobank Sweden’s website provides forms and instructions for bi for biobank applications, as well as contact details for biobank coordinators and Regional Biobank Centres.
Handle personal data correctly
The General Data Protection Regulation (GDPR) governs whether and how personal data may be processed in research.
The organisation responsible for the personal data is the organisation that:
- processes the personal data as part of its activities
- determines which data will be processed and what they will be used for.
Before starting your clinical study, you should find out which requirements apply to the processing of personal data within your organisation. A useful first step is to contact the data protection officer.
Data protection, Swedish Authority for Privacy Protection website External link.
Register the study before it begins
Ensuring that information about clinical studies can be found is important from both an ethical and a scientific perspective. Studies involving humans must be registered before they begin. The results must be reported so that both researchers and the public can follow what the research leads to.
Study registration is:
- a requirement under the Declaration of Helsinki and the World Health Organization (WHO)
- a publication requirement of many scientific journals in the medical field
- a requirement in certain Swedish healthcare regions
- Requirements and guidelines for study registration, WHO website External link.
- Requirements and guidelines under the Declaration of Helsinki, World Medical Association website External link.
- Publication requirements, International Committee of Medical Journal Editors website External link.
- Guidelines and information about study registration, Swedish Research Council website External link.
National agreement on clinical studies
Sweden has a national agreement describing how healthcare, academia and companies should collaborate to strengthen the conditions for conducting clinical studies.
The agreement describes the ethical, legal and financial conditions for collaboration. It covers clinical trials of medicinal products, diagnostics and medical devices and forms the basis of agreements between companies and healthcare providers.
Use templates and supporting documents
Clinical Studies Sweden provides templates and supporting documents to support the structured and quality-assured conduct of clinical trials. The website provides documents that can be used when planning and conducting studies.
Lif, the trade association for research-based pharmaceutical companies in Sweden, also provides templates and other support for clinical trials.
Points to consider during the application stage
Before the study starts, make sure that all required applications, authorisations and agreements are in place.
- Has the study received ethical approval, and have any conditions in the decision been met?
- Have you determined whether authorisation from or notification to the Swedish Medical Products Agency is required?
- Does the study require approval from a radiation protection committee?
- If biobank samples will be used, are the required biobank application and agreement in place?
Specific requirements for medicinal products and medical devices
If your study involves a medicinal product or medical device, specific regulations and application procedures may apply. Depending on the type of study, you may need to obtain authorisation or submit a notification before the study can start.
Under the relevant headings below, you will find information about applying for:
- a clinical trial of a medicinal product
- a clinical investigation of a medical device under the MDR
- a performance study of an in vitro diagnostic medical device under the IVDR.
Contact your regional node within Clinical Studies Sweden if you are unsure which requirements apply or need support during the application process.
Applying for authorisation for a clinical trial of a medicinal product
Determine whether your study requires authorisation
A clinical study involving a medicinal product may meet the definition of a clinical trial of a medicinal product. If it does, authorisation is required before the trial can start.
This may apply to trials of:
- new medicinal products under development
- medicinal products that already have marketing authorisation.
The requirement may apply regardless of whether the trial has an academic or commercial sponsor.
Guidance to help you determine whether your planned study requires authorisation is available on the Swedish Medical Products Agency’s website.
Submit the application through CTIS
Applications under Regulation (EU) No 536/2014 on clinical trials of medicinal products for human use are submitted through the Clinical Trials Information System (CTIS).
The application is assessed in a coordinated process involving the Swedish Medical Products Agency and the Swedish Ethical Review Authority. The Swedish Ethical Review Authority submits the outcome of its ethical review to the Swedish Medical Products Agency, which issues the national decision.
Clinical Studies Sweden provides templates and supporting documents that can be used during the application process.
- Apply for approval of a clinical trial of a medicinal product, the Swedish Medical Products Agency website External link.
- Templates and supporting documents External link.
Clinical trials involving biobank samples
If the clinical trial involves biobank samples, an approved biobank application is also required. The biobank application must be submitted to kliniskaprovningar@biobanksverige.se on the same day as Part II of the clinical trial application is submitted through CTIS. This allows the biobank application and the clinical trial application to be reviewed in parallel.
Applying for a clinical investigation of a medical device
Clinical investigations of medical devices are governed by the EU Medical Devices Regulation (EU) 2017/745 (MDR), which came into effect on 26 May 2021.
Request a CIV ID
Before submitting a notification or application for a clinical investigation of a medical device, you need to request a CIV ID from the Swedish Medical Products Agency.
The CIV ID is a unique identification number assigned to a specific clinical investigation. You request the CIV ID by emailing the Swedish Medical Products Agency.
Notification or application to the Swedish Medical Products Agency
All clinical investigations of medical devices must be either notified to the Swedish Medical Products Agency or submitted to the Agency as an application for authorisation.
The Swedish Medical Products Agency coordinates the review process with the Swedish Ethical Review Authority. All required documentation, including the application for ethical review, must therefore be submitted directly to the Swedish Medical Products Agency.
The application for ethical review must be completed using the designated form available on the Swedish Ethical Review Authority’s website.
The same documentation is required for both notifications and applications. The sponsor is responsible for ensuring that the submitted documentation is complete.
Detailed information about the notification and application procedures is available on the Swedish Medical Products Agency’s website.
• Application and notification, Swedish Medical Products Agency's website External link.
• Medical devices under the MDR and in vitro diagnostic medical devices under the IVDR, Swedish Ethical Review Authority website (in Swedish) External link.
Processing of notifications and applications
The scope and timeframe of the authorities’ review depend on which procedure applies.
Applications subject to the most extensive review procedure are processed within 45 days. Any time required for the sponsor to respond to questions from the authorities is not included in this period.
For clinical investigations that have been notified to the Swedish Medical Products Agency and confirmed as complete, the Swedish Ethical Review Authority issues a decision within 30 days and notifies the sponsor directly. In these cases, no separate decision from the Swedish Medical Products Agency is required.
Clinical investigations involving biobank samples
If the clinical investigation involves biobank samples, an approved biobank application is also required. The biobank application must be submitted to kliniskaprovningar@biobanksverige.se on the same day as the notification or application is submitted to the Swedish Medical Products Agency.
In vitro diagnostic regulation for medical devices (IVDR)
Applying for a performance study of an in vitro diagnostic medical device
Performance studies of in vitro diagnostic medical devices are governed by the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which came into effect on 26 May 2022.
Application, notification and ethical review
Certain types of clinical performance studies of in vitro diagnostic medical devices require either an application for authorisation or a notification to the Swedish Medical Products Agency.
The Swedish Medical Products Agency coordinates the review process with the Swedish Ethical Review Authority. All required documentation, including the application for ethical review, must therefore be submitted to the Swedish Medical Products Agency.
The application for ethical review must be completed using the designated form available on the Swedish Ethical Review Authority’s website.
The same documentation is required regardless of whether the study requires a notification or an application. The sponsor is responsible for ensuring that all required documentation is submitted.
Request a CIV ID
Before beginning the application or notification process, you need to request a CIV ID from the Swedish Medical Products Agency.
The CIV ID is a unique identification number assigned to a specific performance study. You request the CIV ID by emailing the Swedish Medical Products Agency.
Determine whether an application or notification is required
Information about whether your planned performance study requires an application or notification is available on the Swedish Ethical Review Authority’s website.
Performance studies of IVD devices, SwedishMedical Products Agency's website External link.
When an application is required
An application for authorisation must be submitted to the Swedish Medical Products Agency if the clinical performance study:
- involves surgically invasive sampling performed solely for the purposes of the study
- is an interventional clinical performance study, meaning that the test results may be used to guide decisions about treatment or other management of patients
- involves additional invasive procedures or other risks to participants, even if these are unrelated to the sampling procedure
- concerns treatment-guiding diagnostics and is not conducted using leftover sample material.
The term interventional study has a different meaning in the context of clinical trials of medicinal products.
When a notification is required
A notification must be submitted to the Swedish Medical Products Agency if the clinical performance study:
- concerns treatment-guiding diagnostics studied using leftover sample material rather than samples collected specifically for the performance study, in accordance with Article 58(2) of the IVDR
- evaluates a CE-marked product within its intended purpose and involves additional procedures beyond those performed during normal use of the product, where those procedures are invasive or burdensome, in accordance with Article 70(1) of the IVDR.
Application and notification under the IVDR, Swedish Medical Products Agency External link.
Performance studies that do not require an application or notification
Many performance studies can be conducted without an application or notification to the Swedish Medical Products Agency. In these cases, the application for ethical review must be submitted directly to the Swedish Ethical Review Authority through the Ethix application portal.
Processing of notifications and applications
The scope and timeframe of the authorities’ review depend on which procedure applies.
Applications subject to the most comprehensive review procedure are processed within 45 calendar days from the validation date. Any time required for the sponsor to respond to requests for supplementary information from the Swedish Medical Products Agency is not included in this period.
For performance studies that have been notified to the Swedish Medical Products Agency and confirmed as complete, the Swedish Ethical Review Authority issues a decision within 30 days and notifies the sponsor directly. In these cases, no further decision from the Swedish Medical Products Agency is issued.
Performance studies involving biobank samples
If the performance study involves biobank samples, an approved biobank application is required.
The biobank application must be submitted to kliniskaprovningar@biobanksverige.se on the same day as the application or notification is submitted to the Swedish Medical Products Agency.
Related information about Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs) are biological medicinal products based on genes, cells or tissue engineering. ATMPs are regulated by common EU legislation supplemented by Swedish legislation.
The links below provide further information, regulatory guidance, templates and training.
- Advanced therapy medicinal products, Swedish Medical Products Agency website External link.
- Guides, templates and regulatory support, ATMP Sweden website External link.
- ATMP classification and regulatory information, European Medicines Agency website External link.
- Online course: Introduction to advanced therapies, Swedish Academy of Pharmaceutical Sciences website External link.
Research support for clinical trials involving advanced therapy medicinal products
Contact your regional node within Clinical Studies Sweden to find out what research support is available for your study.
Contact your regional node within Clinical Studies Sweden External link.
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