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.
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 clinical trials 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.
What Is A Clinical Trial?, 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.
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