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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: 2019-09-11 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 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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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 (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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Declaration of Helsinki The Declaration of Helsinki is a central guideline for research ethics adopted by the World Medical Association (WMA) in 1964. The Declaration contains ethical principles for doctors and other participants in medical research.
Last modified: 2019-02-20 22.53
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Study types A clinical study is a research study using human subjects to evaluate biomedical or health-related outcomes. On the English version of this website, clinical studies are divided up into the subsidiary groups clinical trial s and
Last modified: 2019-02-20 22.27
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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: 2019-03-04 11.36
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Participating in a clinical study Clinical studies are dependent on persons who volunteer to take part. As a study participant, you are part of driving research forward. Page contents: Page contents: What is a clinical study, and why is it carried
Last modified: 2019-03-12 09.01
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Development initiatives
The regional nodes that collaborate within Clinical Studies Sweden identify joint national challenges. The nodes collaborate in ‘development initiatives’ to find solutions to these. The development initiatives, funded by the
Office for Clinical Studies Committee for Clinical Studies Regional nodes Cooperation Development initiatives Clinical Studies SwedenLast modified: 2019-07-05 -
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: 2018-04-10 -
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: 2019-10-24 -
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: 2018-06-18 -
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
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