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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
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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
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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
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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
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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: 2019-01-15 13.48
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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 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
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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
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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
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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
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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 -
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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 -
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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 -
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Linköping’s SCAPIS project got most “yes” replies It was a challenge to gain acceptance of the SCAPIS project throughout the organisations at both Linköping University and Region Östergötland. However, in June 2018, the last study participants will
Last modified: 2018-11-28 -
Good examples
SCAPIS – a unique knowledge base for researchers today and in the future SCAPIS is the largest population study in Sweden within the cardiovascular and pulmonary system area. It is a world unique project that includes 30,000 patients and involves all
Last modified: 2018-11-28 -
Good examples
Folktandvården Skåne focuses on clinical research Prolonged jaw and facial pain is common in the population, between 10 to 15 percent are estimated to be affected. A new treatment method is being investigated within the framework of a research
Last modified: 2018-11-28 -
Good examples
Clinical research with translational mindset Fredrik Bäckhed is a professor in molecular medicine at the University of Gothenburg, and is leading eminent international research on the role of intestinal flora for health and disease. With one foot in
Last modified: 2018-11-28 -
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Meetings in healthcare give rise to extensive research collaborations Andreas Josefsson is a researcher and soon a specialist in urology. He enjoys standing with one foot in the clinic and the other at the Sahlgrenska Cancer Center. There he conducts
Last modified: 2018-11-28 -
Good examples
Phenomena in the clinic raise research questions Can herpes infection be an important explanation of why some individuals develop Alzheimer's disease? Hugo Lövheim, researcher and physician at the Geriatric Center at Norrlands University Hospital in
Last modified: 2018-11-28
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