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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

Search this site

Your search resulted in 7 hits

  1. / English / Sweden research country

    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
  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: 2018-05-24
  3. / English / News / Personal data handling for research purposes

    News

    The new Data Protection Ordinance will be applied as from 25 May 2018. A subsidiary report includes an analysis of the regulation of personal data handling for research purposes that is possible

    Last modified: 2017-11-27
  4. / English / News / More efficient decision-making path for medicine studies

    News

    In conjunction with the Council of Europe deciding on a new directive for clinical therapy studies using medicines, the Swedish Medical Products Agency and the regional ethical

    Last modified: 2017-11-27
  5. / English / News / New legislation for medical devices

    News

    On Friday 26 May, two new medical technology directives come into force. The new legislation has been negotiated within the EU. The purpose of the directives adopted – one for medical devices and one for

    Last modified: 2017-11-27
  6. / English / For researchers / Research or innovation

    For researchers

    An innovation entails a new or significantly improved product, service or method. It can also be a new marketing method, a new way of organizing business, work organization or external relations. The definition is developed by

    Last modified: 2019-02-15
  7. / English / Sweden research country / Swedish healthcare system

    Sweden research country

    The Swedish healthcare system In Sweden, responsibility for health and medical care is divided between the national government, regions and municipalities. The aim of the healthcare system is to achieve good health and healthcare on equal terms for

    Last modified: 2019-03-12
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