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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 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: 2019-09-11 14.03

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

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


    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


    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?


    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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