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

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: 2018-05-24 11.10

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

Specific rules for medical devices

Specific rules for medical devices Writing a final report Visa mer Visa mindre Writing a final report When a study requires a permit from the Swedish Medical Products Agency, you must write a final report that is available on request, according to

Last modified: 2019-01-15 13.47

Archiving

Archiving When a clinical study is completed, research materials including data and documentation need to be prepared for long-term storage. It is important to research documents are stored and archived in a structured way in order to enable scrutiny

Last modified: 2019-01-15 13.48

Specific rules for medicines

Specific rules for medicines Archiving clinical trials with medicines Visa mer Visa mindre Archiving clinical trials with medicines The research documents that clinical investigators and sponsors are obliged to draw up and store before and during a

Last modified: 2019-01-15 13.48

Specific rules for medical devices

Specific rules for medical devices What shall be archived? Visa mer Visa mindre What shall be archived? Please contact the information owner for information about what is to be archived in your particular study. In general, the sponsor of a study

Last modified: 2019-01-15 13.48

Act concerning Ethical Review Research Involving Humans

The Act concerning the Ethical Review of Research Involving Humans The Act concerning the Ethical Review of Research Involving Humans (2006:460) came into force on 1 January 2004. The purpose of the Act is to protect the individual person and ensure

Last modified: 2019-02-11 10.18

Cooperation on quality systems and work processes

Cooperation on quality systems and work processes The project has been tasked to map quality systems within the various participating nodes, and, based on these, to develop proposals for opportunities for synergies and follow-up projects. The aim is

Last modified: 2018-04-10 10.38

Coordination of feasibilities

Coordination of feasibilities The purpose is to increase the number of clinical studies in Sweden by coordination study requests nationally, regionally and locally via the regional nodes. The aim is to improve the ability to provide quick,

Last modified: 2018-09-04 11.21