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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
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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
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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
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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
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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
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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
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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
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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
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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
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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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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 -
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
Forum Uppsala-Örebro Forum Stockholm-Gotland Gothia Forum Forum South Sweden Study phases FeasibilityLast modified: 2020-02-17 -
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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