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  1. File/document Specific rules for medical devices

    Specific rules for medical devices Medical device with a therapeutic purpose Medical device with a diagnostic purpose Visa mer Visa mindre Please note that as from 26 May 2021, new rules for clinical studies involving medical devices will apply. The

    Last modified: 2020-05-08 13.56

  2. File/document Why do you need to know about statistics?

    Why do you need to know about statistics? Lars Valter works as a statistician at Region Östergötland. In the interview below, he tells us why it might be a good idea to make contact with a statistician when planning to conduct a clinical study. Why

    Last modified: 2019-05-16 15.52

  3. File/document Publication

    Publication Once the results of the study are complete, it is time to start writing your report or article for publication in a scientific journal or other forum. Page contents: Page contents: Writing a scientific article Selecting the journal

    Last modified: 2019-09-11 14.02

  4. File/document Open access and impact factors

    Open access and impact factors Eva Hessman and Helen Sjöblom work at the University of Gothenburg library. In the interview below, they tell us what you might think about when publishing the results of a clinical study in a scientific periodical. How

    Last modified: 2019-05-16 15.47

  5. File/document Specific rules for medical devices

    Specific rules for medical devices Writing a final report Visa mer Visa mindre Please note that as from 26 May 2021, new rules for clinical studies involving medical devices will apply. Writing a final report When a study requires a permit from the

    Last modified: 2020-05-08 13.57

  6. 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

  7. 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

  8. File/document Specific rules for medical devices

    Specific rules for medical devices What shall be archived? Visa mer Visa mindre Please note that as from 26 May 2021, new rules for clinical studies involving medical devices will apply. What shall be archived? Please contact the information owner

    Last modified: 2020-05-08 13.57

  9. 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

  10. 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 (2003:460) came into force on 1 January 2004. The purpose of the Act is to protect the individual person and ensure

    Last modified: 2020-02-18 11.23

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  1. / English / For researchers / Phases clinical trials

    For researchers

    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: 2020-03-05
  2. / 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: 2020-02-17
  3. / English / 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
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