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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

    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

    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: 2020-04-06
  3. / 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
  4. / 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: 2020-03-17
  5. / 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
  6. / English / News / EMA revises guidelines for first-in-human studies

    News

    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
  7. / English / News / New EU-wide law for clinical studies delayed until 2019

    News

    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
  8. / 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
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