Ordförklaringar:

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.

  • Health and medical care or clinical research?

    Compare your idea with previous research

    Search for knowledge among systematic analyses

    Search for gaps in scientific knowledge

    Use data found in registers

    Formulate the problem

    Good things to consider

    Specific rules for medicinal products or medical devices

    Links and related information

  • The design and method of the study are important

    A research plan is necessary for ethical review applications, and functions as a handbook

    Statistical analysis plan

    Information to study participants before consent

    Find out what insurance cover is available for the study participants

    Study budget for all the costs in the project

    Is a health economics evaluation of the study needed?

    Checklist to help plan studies on human

    To consider

    Specific rules for medicines and medical devices

    Links and related information

  • Study participants need to give written consent

    Collecting and managing study data

    What applies for changes to the study protocol after approval?

    Please consider

    Specific rules for medicines and medical devices

    Links and related information

  • Planning before the study begins determines how data is handled and analysed

    Studies with a confirmatory purpose

    Studies with an exploratory purpose

    Data handling when the study is concluded

    Analysis of study data

    Specific rules for medical devices

    Links and related information

  • Writing a scientific article

    Selecting the journal

    Publishing with open access

    Publishing the results in a public database

    Informing study participants of the study results

    To consider

    Specific rules for medicinal products or medical devices

    Links and related information

  • Public documents must be archived

    Screening of personal data

    To consider

    Specific rules for medicinal products or medical devices

    Links and related information

It is easier to apply for authorisation for a clinical study if thorough preparations have been made and there is a well worked out and detailed research plan. Once the research plan is completed, you must apply for authorisation from the Ethical Review Authority and in many cases also from the Medical Products Agency.

Applying for an ethical review

If you are planning to carry out research on living and/or deceased persons, on biological material from humans, or research that involves handling sensitive personal data, you must apply for and have your research ethically reviewed and approved by the Ethical Review Authority. In order to formulate your application as well as possible, it is important to know the starting points for the ethical review.

According to the Act Concerning the Ethical Review of Research Involving Humans (SFS 2003:460), research may only be approved if:

  • it can be conducted with respect for human dignity
  • human rights and fundamental freedoms have been taken into account, at the same time as consideration has been paid to the interest in the development of new knowledge through research
  • the well-being of humans has been considered and given priority ahead of the needs of society and science
  • the risks it may entail to the health, safety and personal integrity of participants are outweighed by the scientific value
  • it is to be conducted by, or under the supervision of, a researcher who possesses the necessary scientific competence

You can read more about research ethics in medical research in the Declaration of Helsinki.

Application for ethical review is done via the Ethical Review Authority's website. On the website you can also find answers to commonly asked questions, guidance for application and information about how to write the information for study participants.

An ethical review is carried out only once the application is complete, which means that the form has been filled in correctly, the fee has been paid and all information requested has been submitted. The administration time for the Ethical Review Authority is approximately 60 days, information on fees for ethics review can be found on the authority's website.

Etikprövning - så går det till, the Swedish Ethical Review Authority (In Swedish). External link.

If your study needs to be approved by the Swedish Medical Products Agency, the process for ethical review has been affected by new EU regulations for both clinical trial on medicinal products and medical devices. Find out what applies to your study in the sections "Special rules for medicines and medical devices" further down the page.

Information about the Ethical Review Act, the Swedish Ethical Review Authority External link.

Lag (2018:1091) med kompletterande bestämmelser om etisk granskning till EU:s förordning om kliniska prövningar av humanläkemedel, the Swedish Riksdag (In Swedish) External link.

Application for ethical review and guidance for the design of a research plan, the Swedish Ethical Review Authority (in Swedish) External link.

Answers to frequently asked questions about the application, the Swedish Ethical Review Authority (in Swedish) External link.

Information on how data for study participants should be designed, the Ethical Review Authority (in Swedish) External link.

Information on fees for ethics review, the Swedish Ethical Review Authority (in Swedish) External link.

Generic templates for conducting clinical studies, Apotekarsocietet's section for Clinical Studies in collaboration with LIF and the Swedish Medical Products Agency (in Swedish) External link.

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.

Information regarding rules for clinical studies in which study participants are exposed to ionizing radiation, the Swedish Ethical Review Authority External link.

Application for access to biobank samples

In order to conduct research on samples covered by the Biobanks Act, an approved biobank application is required. Human biological samples that are taken in health care and are traceable to the individual sample donor are covered by the Biobanks Act. Biobank samples are taken for care, diagnostics and treatment or for clinical research and can be anything from fluids such as blood, serum, plasma and saliva to stool samples and tissue samples such as biopsies, tumors and organs.

Approval from the Swedish Ethics Review Authority is always required when biological samples are taken for research, regardless of whether they are covered by the Biobanks Act or not. If you are unsure whether samples in the study are covered by the Biobanks Act, you can contact the region's biobank coordinator or a Regional Biobank Center (RBC) for advice.

The biobank application is sent to the region's biobank coordinator or to an RBC for review and approval. You can also get advice in connection with the biobank application or to get tips when designing research person information and the parts of the application for ethical review that are about tests.

New EU regulations for clinical trials on medicinal products and medical devices also affect the process for applying for biobanks. Read more under the sections "Specific rules for medicines and medical devices" further down the page.

Forms and instructions for biobank applications and contact information for, among others, biobank coordinators and RBC (in Swedish), Biobank Sweden's website External link.

Lagar och regelverk (In Swedish)

Finding out what applies for handling of personal data

The General Data Protection Regulation (EU) 2016/679 regulates whether and how personal data may be handled for research purposes. The legal entity that handles the personal data in its operation and who decides on what data is to be handled, and what the data shall be used for is responsible for the handling of personal data (personal data controller).

Before starting your clinical study, you should find out what applies for handling of personal data within your organisation. If there is a personal data officer, this is a suitable person to contact.

Information about the handling of personal data is available on the Swedish Authority for Privacy Protection's website External link.

Register your study before the start of the study

The fact that it is easy to find information about clinical studies is important from both an ethical and a scientific perspective. In research on humans, studies must be registered before they begin and results reported so that both researchers and the general public can follow what the research leads to. These are requirements and guidelines set by the World Health Organization (WHO) and the Declaration of Helsinki. Many scientific journals in the medical field have also introduced study registration as a publication requirement. In addition, some healthcare regions have their own requirements for registration.

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. 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 are working together to develop the conditions for conducting clinical studies.

The agreement sets out the conditions for the collaboration, which includes clinical trials of medicinal products and clinical trials of medical devices in Sweden.

Templates and support for clinical trials, Swedish Association of Local Authorities and Regions (SKR) website External link.

Reports, agreements and templates, LIF - the research-based pharmaceutical companies in Sweden website External link.

Keep in mind

  • 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 necessary?

Specific rules for medicines and medical devices

There are specific rules to follow for clinical studies involving medicinal products or medical devices.

As of January 31, 2022, a EU-wide regulation on clinical trials of medicinal products for human use, 536/2014, also known as the Clinical Trials Regulation (CTR), will apply. More information is available on the website of the Swedish Medical Products Agency. External link.

Application for approval of medicinal product trial

Clinical studies investigating medicinal products may fall under the definition of clinical trials of medicinal products, in which case a specific approval is required. This can apply to studies conducted on new medicinal products under development, but also to studies on medicinal products already approved for sale. The purpose can be both commercial and academic.

For guidance on whether your planned medicinal product trial is subject to approval, a guide is published on the Swedish Medical Products Agency's website.

Find out if your trial is subject to approval, Swedish Medical Products Agency website. External link.

Clinical trial of a medicinal product CTR

Applications under EU Regulation 536/2014 are submitted via the EU portal CTIS (Clinical Trials Information System). Both the Swedish Medical Products Agency and the Ethical Review Authority will then have access to the application. The application will be coordinated and the applicant will receive only one decision that applies to both authorities.

For details on how to apply for approval of a clinical trial of a medicinal product under EU regulation, see the Swedish Medical Products Agency website. External link.

Clinical Studies Sweden has developed templates and supporting documents to support the application.

Templates and supporting documents External link.

Does your clinical trial of a medicinal product include biobank samples

If your clinical trial of a medicinal product involves biobank samples, an approved biobank applicationis required. According to the application procedure, the biobank application should be submitted to kliniskaprovningar@biobanksverige.se in parallel with the submission of the clinical trial application in CTIS.

Biobank application according to EU regulation, Biobank Sweden website. External link.

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.

Information on the authority review and authorisation procedures, Swedish Medical Products Agency website. External link.

Information on the authority review and authorisation procedures, Ethical Review Authority website. External link.

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.

Explore the possibility of a coordinated authorisation procedure, Swedish Medical Products Agency website. 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.

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.

Instructions for notification and application, Swedish Medical Products Agency website. External link.

Application form and instructions for the application, Ethical Review Authority website. External link.

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 Swedish Medical Products Agency. External link.

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.

Links and related information

More information on the Ethical Review Act External link.

More information on the Helsinki Declaration External link.

Ethical review - how it works External link.

The Ethical Review Authority's answers to frequently asked questions about ethical review External link.

The Ethical Review Authority's guidance on the design of the research plan External link.

Information from the Ethical Review Authority on documentation for study participants External link.

Information on ethical review fees External link.

Generic templates from the Swedish Pharmacy Association, LIF and the Swedish Medical Products Agency External link.

More information on studies where participants are receiving radiation External link.

Forms and instructions for biobank applications and contact details for e.g., biobank coordinators and RBC, Biobank Sweden's website External link.

Data protection, website of the Swedish Authority for Privacy Protection External link.

Clinicaltrials.gov External link.

Joint agreement between SKR and LIF External link.

Links - medical technology

Template for the annex “Declaration of conformity”, website of the Swedish Medical Products Agency External link.

Information review and approval procedures on the Planning page External link.

Information on the authority's review and approval procedures, Swedish Medical Products Agency website External link.

Information on the authority's review and approval procedures, Ethical Review Authority website External link.

Explore the possibility of a coordinated approval procedure, Swedish Medical Products Agency website External link.

Application procedure for medical devices, Biobank Sweden website External link.

Links - medicines

Find out if your medicinal product trial is subject to approval, Swedish Medical Products Agency website External link.

More information on transitional rules on the Swedish Medical Products Agency website External link.

For details about applying for approval of a clinical trial of a medicinal product under the old regulations, Swedish Medical Products Agency website External link.

For details on how to apply for approval of a clinical trial of a medicinal product under the new EU regulation, Swedish Medical Products Agency website External link.

Biobank application according to the new EU regulation, Biobank Sweden website. External link.

Application procedure during the transition period under the old EU directive, Biobank Sweden website External link.

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