Go to content

Our websites

Ordförklaringar:
Svenska
Svenska

Research process

This page describes the research process and what you should consider when conducting a clinical study. Depending on the type of study you want to do, the process and regulations look different. Some parts of the process are general, others are specific to a certain type of study.

  • 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

  • Applying for an ethical review

    Research projects in which study participants are irradiated

    Application for access to biobank samples

    Finding out what applies for handling of personal data

    Register your study before the start of the study

  • Study participants need to give written consent

    Collecting and managing study data

    What applies for changes to the study protocol after approval?

    Please consider

  • 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

Idea

At the idea phase, you compare your idea with previous research in the area and formulate the research question, which determines the type of study to be carried out, and the type of data to be collected.

Planning

Once the problem formulation is completed, the planning of your clinical study starts. This includes writing a research plan, producing information and arranging insurance for the study participants, and drawing up a study budget. For clinical trials with medicines and medical devices, there are special rules concerning the allocation of responsibility and data handling.

Application

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.

Execution

Once all authorisations required have been obtained, recruitment of study participants and collection of data begins. For clinical trials with medicines and medical devices, there are special rules concerning study folders, monitoring and reporting.

Analysis

Once all the data have been collected, the study results are analysed and the outcome compared with the original question.

Publication

The results of your study may be disseminated to research colleagues, healthcare personnel and the general public with the help of scientific publications.

Archiving

Once your clinical study has been completed, research material including data and documentation need to be prepared for long-term storage and archiving.

Specific rules for clinical trials

Several of the steps in the information on the study process have specific instructions for clinical trials with medicines or medical devices.

You can find advice on how to determine whether your medicine study is a clinical trial or an observation study on the Medical Product Agency's website.

Apply for clinical trial permit, Swedish Medical Products Agency's webpage External link.

All clinical trials with medical devices involving non-CE marked medical devices or medical devices that are CE marked for other use than that intended in the study shall be notified to the Medical Products Agency.

Clinical investigation of medical device, Swedish Medical Products Agency's webpage External link.

Published: