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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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Development initiatives
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: 2020-01-10 -
Development initiatives
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: 2019-12-31 -
Development initiatives
The purpose of the development initiative is to contribute to increased quality and effectiveness in the implementation of clinical studies by establishing collaboration between the
Last modified: 2019-05-29 -
Development initiatives
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 -
Development initiatives
Clinical Studies Sweden works to increase the number of international and national clinical studies of high quality in Sweden, which requires that there is a sufficient number of well-qualified
Last modified: 2019-01-16 -
Development initiatives
The purpose is to investigate opportunities and prerequisites for a national data collection system (Electronic Data Capture (EDC) system) and a central randomising function for academic research. The project shall
Last modified: 2019-01-16 -
Development initiatives
National network for research nurses – prestudy The aim of the prestudy is to investigate needs and prerequisites for a national network for research nurses. Background Research nurses are important players in clinical studies; for the study
Last modified: 2020-02-20 -
Development initiatives
he purpose is to develop a national standard for R-RCT (Register-based Randomised Clinical Trials) that facilitates and increases the number of register-based randomised clinical studies. The number of randomised clinical
Last modified: 2019-01-16 -
Development initiatives
he purpose of the development initiative is to create a national website for clinical studies that functions as a “single point of entry” for business and academia, as well as the healthcare system and study
Last modified: 2019-02-26 -
Development initiatives
he aim is to develop a national research subject survey. The results of compiled surveys can provide statistical data for improvement work at research clinics and enable adaptations of studies according to the participants'
Last modified: 2019-02-15
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