Application
When the research plan is ready, you should apply for approval from the Ethical Review Authority and, in many cases, also from the Medical Products Agency.
- Apply for authorisation for your clinical study
- Apply for ethical review
- If your study is also reviewed by the Swedish Medical Products Agency
- Research projects in which study participants are irradiated
- Apply for access to biobank samples
- Handle personal data correctly
- Register your study before it starts
- Agreement on the conduct of clinical studies
- Templates and support documents for clinical trials
- Points to consider
- Specific rules for medicines and medical devices
- Apply for authorisation for a clinical trial of a medicinal product
- How to apply for a clinical trial of a medicinal product
- If the study involves biobank samples
- Related information about ATMP
Apply for authorisation for your clinical study
Applying for authorisation for a clinical study is easier if you have made thorough preparations and developed a clear research plan. Once this has been done, you must apply for ethical review by the Swedish Ethical Review Authority, and in many cases also for authorisation from the Swedish Medical Products Agency.
Apply for ethical review
You must apply for ethical review by the Swedish Ethical Review Authority if your research involves:
- studies on living or deceased persons
- the use of biological material from humans
- the processing of sensitive personal data
In order to prepare a well-founded application, it is important to be familiar with the principles underlying ethical review.
Requirements for ethical approval
According to the Act Concerning the Ethical Review of Research Involving Humans (SFS 2003:460), research may only be approved if:
- is conducted with respect for human dignity
- takes human rights and fundamental freedoms into account
- gives priority to the well-being of individuals over the interests of society and science
- involves risks that are reasonable in relation to the scientific value
- is conducted by, or under the supervision of, a researcher with sufficient competence
Further information on research ethics in clinical research is available in the Declaration of Helsinki.
Before submitting your application
Applications for ethical review are submitted via the Swedish Ethical Review Authority’s website. An application is reviewed only once it is complete, meaning that:
- the application form has been correctly completed
- the fee has been paid
- all requested documentation has been submitted
The processing time is approximately 60 days.
On the Authority’s website you will find answers to frequently asked questions, guidance for the application process and information on how to prepare information for study participants.
- Information about the Ethical Review Act, the Swedish Ethical Review Authority External link.
- Ethical review – how it works External link.
- Application for ethical review and guidance on designing a research plan External link.
- Answers to frequently asked questions about the application ( in Swedish) External link.
- How information for study participants should be designed (in Swedish) External link.
- Fees for ethical review External link.
If your study is also reviewed by the Swedish Medical Products Agency
If your study requires authorisation from the Swedish Medical Products Agency, the ethical review process is affected by EU regulations governing clinical studies involving medicinal products and medical devices.
Find out what applies to your study in the sections on Special rules for medicinal products and Special rules for medical devices further down the page.
Research projects in which study participants are irradiated
There are special regulations for medical exposure to ionizing radiation, such as X-ray examinations. These become applicable in clinical studies where participants are exposed to ionizing radiation.
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 in order to conduct research using biobank samples depend on:
- how the study is designed
- which biobank is responsible for the samples
In many cases, an approved biobank application is required before the study can start.
How to apply
When biological samples are to be collected, approval from the Swedish Ethical Review Authority or authorisation under the relevant EU regulation for clinical trials and performance studies is always required, regardless of whether the samples are covered by the Biobank Act.
Biobank applications are submitted to the regional biobank coordinator or a Regional Biobank Centre (RBC). They can also provide advice, for example regarding information for study participants or relevant parts of the ethical review application.
EU regulations for clinical studies involving medicinal products and medical devices also affect the biobank application process. Further information is available in the sections on special rules for medicinal products and medical devices.
On Biobank Sweden's website there is information about:
Handle personal data correctly
The General Data Protection Regulation (GDPR) governs whether and how personal data may be processed in research.
Responsibility for personal data lies with the organisation that:
- processes the personal data in its activities
- determines which data are processed and for what purpose
Before starting your clinical study, you should find out what applies to the handling of personal data within your organisation. A suitable first step is to contact the data protection officer.
Register your study before it starts
Ensuring that information about clinical studies is easily accessible is important from both an ethical and a scientific perspective. In research involving humans, studies must be registered before they start and results must be reported, so that both researchers and the public can follow the outcomes of research.
Study registration is:
- a requirement under the Declaration of Helsinki and the World Health Organization (WHO)
- a publication requirement in many medical scientific journals
- a requirement in certain healthcare regions
More information about study registration
Further information on study registration is available from WHO, the Declaration of Helsinki, the International Committee of Medical Journal Editors (ICMJE) and the Swedish Research Council.
- Requirements and guidelines, World Health Organization External link.
- Requirements and guidelines, Declaration of Helsinki External link.
- About publication requirements, International Committee of Medical Journal Editors (ICMJE) External link.
- Guidelines and further information on student registration, the Swedish Research Council External link.
Agreement on the conduct of clinical studies
In Sweden, healthcare, universities, colleges and the pharmaceutical industry work together to strengthen the conditions for conducting clinical studies.
A national agreement between the Swedish Association of Local Authorities and Regions (SKR) and the life science industry defines the ethical, legal and financial conditions for collaboration between healthcare and companies. The agreement applies to clinical trials of medicinal products, diagnostics and medical devices, and forms the basis for contracts between companies and healthcare providers.
Agreement on clinical trials of pharmaceuticcals and medical technology External link.
Templates and support documents for clinical trials
Clinical Studies Sweden provides templates and support documents to facilitate a structured and quality-assured conduct of clinical trials. On this website you will find documents that can be used in the planning, documentation and follow-up of studies.
Lif, the trade association for research-based pharmaceutical companies, also provides templates and other support related to clinical trials.
Points to consider
- Is the study approved by the Ethical Review Authority and have any conditions in the decision been met before the study starts?
- Is approval from the Swedish Medical Products Agency is also required.
- Does the study need approval from the radiation protection committee?
- Is the establishment of a biobank agreement necessary?
Specific rules for medicines and medical devices
There are specific rules to follow for clinical studies involving medicinal products or medical devices.
This information explains when authorisation is required for clinical trials of medicinal products, how to apply, and what support is available during the application process.
Apply for authorisation for a clinical trial of a medicinal product
Clinical studies involving medicinal products may fall under the definition of a clinical trial of a medicinal product. In such cases, specific authorisation is required before the study can start. This may apply to studies of new medicinal products under development as well as to studies of medicinal products that are already authorised for marketing, regardless of whether the purpose is academic or commercial.
Guidance on whether your planned study requires authorisation is available on the Swedish Medical Products Agency’s website
How to apply for a clinical trial of a medicinal product
Applications under EU Regulation (EU) 536/2014 are submitted via the EU portal CTIS (Clinical Trials Information System). The application is reviewed in a coordinated process by the Swedish Medical Products Agency and the Swedish Ethical Review Authority, which issue a joint decision.
Clinical Studies Sweden has developed templates and supporting documents that can be used to support 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.
If the study involves biobank samples
If your clinical trial of a medicinal product involves biobank samples, an approved biobank application is required. According to the application procedure, the biobank application must be submitted to kliniskaprovningar@biobanksverige.se in parallel with the submission of the clinical trial application in CTIS.
Notification and application to the Swedish Medical Products Agency
Most medical device clinical trials must be notified or applied for to the Swedish Medical Products Agency. In most cases, the Swedish Medical Products Agency coordinates the review with the Ethical Review Authority. This means that it is the sponsor who submits application documents to be reviewed by the Ethical Review Authority when these are attached to the notification or application sent to the Swedish Medical Products Agency. Read more in the section Planning on the website
It is only clinical trials of CE-marked medical devices, where the study participants are not subjected to additional invasive or strenuous procedures that are not coordinated as above. In this case, it is still the entity responsible for research who applies for the ethical review directly to the Ethical Review Authority via the Ethix application portal.
What should be submitted to the Medical Products Agency and the Ethical Review Authority?
Whether it is an application or a notification, the requirements for the documentation to be submitted for review are the same. The dossier consists of an application form and mandatory annexes submitted electronically. Mandatory annexes to the application are defined in each authority's application form (see links below).
Annexes such as the investigator's brochure, written information to be provided to study participants and the clinical investigation plan are recommended to be designed in accordance with ISO 14155:2020, read more in the Planning section. The annexes should demonstrate, among other things, that the investigational device is ready for a medical device clinical trial, i.e., that the device meets the general safety and performance requirements apart from the aspects covered by the study.
What happens to my notification or application?
Depending on the authorisation procedure applied, the authorities' review will be different in scope and timeframe. The most extensive review procedure takes 45 days after a valid application is received.
For clinical trials of medical devices notified to the Swedish Medical Products Agency, the Ethical Review Authority makes a decision within 30 days (no further decision from the Swedish Medical Products Agency will be obtained).
For clinical trials of medical devices applied to the Swedish Medical Products Agency, and when the product is:
- invasive in Class IIa or IIb or a product in Class III, the Swedish Medical Products Agency and the Ethical Review Authority will make a coordinated decision within 45 days.
- Class I or a non-invasive product in Class IIa or IIb, a validation decision from the Swedish Medical Products Agency must be waited for and then the Ethical Review Authority will make a decision within 40 days.
If the trial will be conducted in several countries, there will be the possibility of a coordinated authorisation procedure within the EU. The coordinated authorisation procedure is being implemented in the EU.
Does your clinical trial of a medical device include biobank samples?
If your clinical trial involves biobank samples, an approved biobank applicationis required.
The Regional Biobank Centre is also part of the coordinated process to facilitate the establishment of the Biobank Agreement. A Biobank Application must always be submitted to the Regional Biobank Centre at the same time as the clinical trial application is sent to the Swedish Medical Products Agency.
Application procedure for medical devices, Biobank Sweden website External link.
In vitro diagnostic regulation for medical devices (IVDR)
The new IVD legislation introduces the requirement to apply for approval from or notification to the Swedish Medical Products Agency for certain types of clinical performance studies of in vitro diagnostic products. Please read more in the section Planning .
Clinical performance studies that are notifiable to the Swedish Medical Products Agency are those studies that involve:
- treatment-guiding diagnostics using remaining sample material
- that a CE marked diagnostic device is studied within the scope of its intended purpose, but the study involves additional invasive or strenuous procedures for the subject.
Clinical performance studies that require an application to the Swedish Medical Products Agency are such studies that involve:
- an intervention study of clinical performance
- that surgically invasive sampling is performed and where the procedure is done solely for the purposes of the study
- that additional invasive procedures are performed or other risks to subjects exist, even if these are not related to the sampling procedure
- treatment-guiding diagnostics where samples/materials are taken specifically for the study.
These types of performance studies must be notified or applied for to the Swedish Medical Products Agency, which coordinates the review with the Ethical Review Authority. This means that application documents to be reviewed by the Ethical Review Authority are attached to the notification or application sent to the Swedish Medical Products Agency.
However, it will still be possible to conduct many performance studies without either notification or application to the Swedish Medical Products Agency. For these an ethical review must be applied for to the Ethical Review Authority via the Ethix application portal.
What should be submitted to the Medical Products Agency and the Ethical Review Authority?
Whether it is an application or a notification, the requirements for the documentation to be submitted for review are the same and are set out in Chapter I of Annex XIV of the IVDR. The application form and mandatory annexes are submitted electronically.
Annexes such as the investigator's brochure, written information to be provided to study participants and the clinical performance study protocol are recommended to be designed in accordance with ISO 20916:2019, please read more in the Planning section. The annexes should demonstrate, among other things, that the investigational device is ready for a medical device clinical trial, i.e., that the device meets the general safety and performance requirements apart from the aspects covered by the study.
What happens to my notification or application?
Depending on the authorisation procedure applied, the authorities' review will be different in scope and timeframe. The most extensive review procedure takes 45 days after a valid application is received.
For clinical performance studies notified to the Swedish Medical Products Agency, the Ethical Review Authority makes a decision within 30 days (no further decision from the Swedish Medical Products Agency is obtained).
For applications of clinical performance studies to the Swedish Medical Products Agency, the Swedish Medical Products Agency and the Ethical Review Authority make a coordinated decision within 45 days.
Information on the review and approval procedures of the Ethical Review Authority. External link.
Does your clinical trial of a medical device include biobank samples?
If your clinical trial involves biobank samples, an approved biobank applicationis required. The Regional Biobank Centre is also part of the coordinated process to facilitate the establishment of the Biobank Agreement. A Biobank Application must always be submitted to the Regional Biobank Centre at the same time as the clinical trial application is sent to the Swedish Medical Products Agency.
Application procedure for medical devices, Biobank Sweden website External link.
Related information about ATMP
ATMP (Advanced therapy medicinal products)
Advanced therapy medicinal products (ATMP) are human medicines, based on genes, tissues or human cells. They offer ground-breaking new opportunities for the treatment of diseases and injuries. More information about advanced therapy:
For guide/templates and regulatory guide, ATMP project website External link.
Classifications, regulatory information, European Medicines Agency website External link.
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