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  1. 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

  2. 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

  3. 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

  4. File/document Laws regulations

    Laws and regulations When a clinical study is conducted, a number of legal requirements must be complied with in order for the research to be legal. The legislation aims primarily to protect the persons participating in a clinical study, and to

    Last modified: 2019-02-20 23.02

  5. 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

  6. File/document Declaration of Helsinki

    Declaration of Helsinki The Declaration of Helsinki is a central guideline for research ethics adopted by the World Medical Association (WMA) in 1964. The Declaration contains ethical principles for doctors and other participants in medical research.

    Last modified: 2019-02-20 22.53

  7. File/document Study types

    Study types A clinical study is a research study using human subjects to evaluate biomedical or health-related outcomes. On the English version of this website, clinical studies are divided up into the subsidiary groups clinical trial s and

    Last modified: 2019-02-20 22.27

  8. File/document Phases clinical trials

    The various phases of clinical trials A clinical trial is conducted according to a study protocol set in advance. A trial may last from a couple of weeks up to a year or more, depending on the question, the disease, the nature of the therapy and how

    Last modified: 2019-03-04 11.36

  9. File/document Participating in study

    Participating in a clinical study Clinical studies are dependent on persons who volunteer to take part. As a study participant, you are part of driving research forward. Page contents: Page contents: What is a clinical study, and why is it carried

    Last modified: 2019-03-12 09.01

  10. File/document Development initiatives

    Development initiatives The regional nodes that collaborate within Clinical Studies Sweden identify joint national challenges. The nodes collaborate in ‘development initiatives’ to find solutions to these. The development initiatives, funded by the

    Last modified: 2019-07-05 13.22

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Your search resulted in 3 hits

  1. / English / Clinical Studies Sweden

    Clinical Studies Sweden

    Clinical Studies Sweden is a collaboration between Sweden’s six healthcare regions, funded and supported by the Swedish Research Council. The collaboration aims to simplify and develop the work of clinical studies. The six

    Last modified: 2019-09-30
  2. / English / News / Karolinska Trial Alliance about the ongoing work on regional and national coordination


    Karolinska Trial Alliance is the regional node for Stockholm and Gotland in the national collaboration Clinical Studies Sweden. Maria Englund, node

    Last modified: 2019-08-22
  3. / English / Sweden research country / Swedish healthcare system / Phase 1 units

    Sweden research country

    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
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