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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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Good examples
Subscribe Subscribe Close Good examples Here we gather good examples of how to work with clinical studies within healthcare. Show all categories Study participant Researcher Life science industry Relative Patient organisation Healthcare professional
Last modified: 2019-05-23 -
Good examples
Network of women’s clinics wants to raise the quality of clinical research SNAKS is a network involving all women’s clinics in Sweden, and wants to improve the opportunities to conduct clinical multi-centre studies of high quality. Verena Sengpiel,
Last modified: 2019-10-28 -
Good examples
Clinical research needs to pay more attention to the fact that human beings are complex Foto: Erik Andersson Ulrika Sandén is an author and researcher in innovation technology at the Faculty of Engineering (LTH), Lund University. Through of her own
Last modified: 2019-10-22 -
Good examples
Healthcare – a hidden goldmine that can lift clinical research Ola Andersson is a consultant neonatologist at Skåne University Hosptail, and a researcher at Lund University. His research into the advantages of delayed cord clamping of newborns has
Last modified: 2019-07-05 -
Good examples
HOPE – unites healthcare and research to benefit children with cancer Every year, 300 children in Sweden are diagnosed with cancer. Thanks to research and new therapies, the majority recover, but still around 20 per cent die from different types of
Last modified: 2019-07-05 -
Good examples
KTA-Prim wants to increase clinical research in primary care Malin Frank is a specialist in general medicine and school physician in Stockholm. One day a week, she works as a clinical investigator at KTA-Prim, a reception center where she meets
Last modified: 2018-11-28 -
Good examples
When Eva Hellström Lindberg was a newly appointed doctor, she met a number of patients with a mysterious blood disease that had no name at the time. It wakened her curiosity and
Last modified: 2018-11-28 -
Good examples
Emma Larsson at Gothia Forum in Gothenburg has worked with the research project SCAPIS for almost five years. She is responsible for coordinating work between the six participating cities, which means
Last modified: 2018-11-28 -
Good examples
Children and adults digest and react to medicines in different ways. Despite there being differences, many medicines have not been studied in children, and knowledge about long-term effects and
Last modified: 2018-11-28 -
Good examples
Work environment, research and development crucial when child oncology went from personnel shortages to queueing Eva Sjödin Eriksson is the unit manager of child oncology at Norrland University Hospital in Umeå. In twelve years, she has managed to
Last modified: 2018-11-28
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