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Information Clinical studies – step by step What does the study process look like and what needs to be considered when conducting a clinical study? The pages in Clinical Studies - step by step, are primarily aimed at persons working within healthcare

Last modified: 2021-03-31 13.45

Sweden research country

Sweden as a research country Research plays an important role as an engine for growth in both the global and the Swedish economy. Medical research shall contribute to better health, increased quality of life and decreased societal cost. Research is

Last modified: 2018-11-13 16.01

Swedish healthcare system

The Swedish healthcare system In Sweden, responsibility for health and medical care is divided between the national government, regions and municipalities. The aim of the healthcare system is to achieve good health and healthcare on equal terms for

Last modified: 2020-02-25 14.38

Phase 1 units

Phase 1 units for clinical trials with medicines The first phase in a clinical trials programme for medicines is called Phase 1. If it is the first time a new medicine is given to a human being, the study is called a First-in-Human trial. A trial

Last modified: 2020-12-10 16.26

For researchers

For researchers The “For researchers” pages are primarily aimed at researchers who want to conduct or learn more about clinical studies. Here you can find information about the study process, different study types and the laws and regulations that

Last modified: 2019-01-16 15.29

Idea

Idea When you have an idea and want to find out whether it is sound, it is a good idea to start by making an inventory of what is already documented in the area. By carrying out a literature search and a review of registers and databases, you can map

Last modified: 2020-04-06 16.07

Gaps in knowledge and systematic literature reviews

Gaps in knowledge and systematic literature reviews Nathalie Peira works as project manager at the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU). In the interview below, she tells us how the work with

Last modified: 2019-05-16 15.56

Specific rules for medical devices

Specific rules for medical devices Find out whether your idea includes a medical device Is the product ready to be used in a clinical study? Formulate the hypothesis or research question Clinical evaluation of the product Which studies need a permit

Last modified: 2020-08-31 16.25

Specific rules for medicines

Specific rules for medicines A trial protocol is required for the application to the Medical Products Agency Allocating roles and responsibilities in accordance with Good Clinical Practice Set up systems for data collection, data processing and data

Last modified: 2020-12-09 18.42

Specific rules for medical devices

Specific rules for medical devices Design of a medical device study Medical device aspects on ethical review Does the study need a permit from the Medical Products Agency? Medical device studies abroad An adapted clinical investigation plan is needed

Last modified: 2020-12-09 18.45