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  1. File/document 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

  2. File/document 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

  3. File/document 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

  4. File/document 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

  5. File/document 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

  6. File/document 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

  7. File/document 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

  8. File/document 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

  9. File/document 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

  10. File/document 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

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  1. / English / News / EMA revises guidelines for first-in-human studies

    News

    To facilitate matters for actors and reduce the risks for participants in clinical studies, the European Medicines Agency (EMA) has revised its guidelines for first-in-human studies.

    Last modified: 2017-11-24
  2. / English / News / New EU-wide law for clinical studies delayed until 2019

    News

    EMA reports that the point in time when the Clinical Trials Regulation (Regulation (EU) No 536/2014) comes into force has been delayed from October 2018 to 2019. The decision was

    Last modified: 2017-11-24
  3. / English / News / What is the economic value of medical researc?

    News

    Accordning to a new British study, society benefits by 25 pence per year for every pound invested in research - every year, forever. The figure is the result of a number of "What is it worth

    Last modified: 2018-02-01
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