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Clinical studies - step by step

The pages in “Clinical studies – step by step” are aimed in the first instance at persons working within healthcare and research who want to know more about the study process, and what needs to be considered when conducting a clinical study. The process and the regulatory framework vary depending on the type of study you are carrying out. Some parts of the process are general, others are specific for a certain type of study.

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 an ethical review board 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.

Study types

On the website, clinical studies are divided up into the subsidiary groups:

  • clinical trials
  • observation studies
  • diagnostic studies
  • qualitative studies

Specific rules for clinical trials

Several of the steps in Clinical studies – step by step 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 websiteexternal link, opens in new window.

All clinical trials with medical devicesexternal link, opens in new window 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.


Date created: 2017-11-07
Last published: 2017-12-20

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