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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 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. File/document Information on clinical studies on medical devices

    Information on clinical studies on medical devices The aim is to complement the website kliniskastudier.se with neutral, quality assured information on all aspects of clinical studies on medical devices. There should also be summarised information on

    Last modified: 2019-02-11 14.19

Search this site

Your search resulted in 9 hits

  1. / 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
  2. / English / For researchers / Clinical studies - step by step / Planning

    For researchers

    Once the problem formulation is completed and you know what questions are to be answered and what data need to be collected and analysed, the planning of your clinical study starts. Page contents: Page contents: The design and method of the

    Last modified: 2019-09-11
  3. / English / For researchers / Clinical studies - step by step / Execution

    For researchers

    Once the approvals required for your clinical study have been obtained, the practical work on the study can start. Page contents: Page contents: Study participants need to give written consent Collecting and managing study data What applies

    Last modified: 2019-09-11
  4. / English / For researchers / Clinical studies - step by step / Idea

    For researchers

    When you have an idea and want to find out whether it is sound, it is a good idea to start by making an inventory of what is already documented in the area. By carrying out a literature search and a review of registers and databases, you can map

    Last modified: 2019-09-11
  5. / English / For researchers / Clinical studies - step by step / Application

    For researchers

    It is easier to apply for authorisation for a clinical study if thorough preparations have been made and there is a well worked out and detailed research plan. Once the research plan is completed, you must apply for authorisation from the

    Last modified: 2019-09-11
  6. / English / For researchers / Clinical studies - step by step / Analysis

    For researchers

    It is a good idea to consult a statistician already during the planning phase to enable the production of correctly analysed data and publication of the result. Early preparation is crucial for producing a good study design, the correct

    Last modified: 2019-09-11
  7. / English / For researchers / Clinical studies - step by step / Publication

    For researchers

    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
  8. / English / For researchers / Clinical studies - step by step

    For researchers

    The pages in “Clinical studies – step by step” are aimed in the first instance at persons working within healthcare and research who want to know more about the study process, and what needs to be considered when

    Last modified: 2019-09-11
  9. / English / For researchers / Clinical studies - step by step / Archiving

    For researchers

    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
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  • Laws 5
  • Regulations 5
  • Study phases 1
  • Study process 9
  • Study types 5