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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
Search this site
Your search resulted in 33 hits
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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: 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: 2018-09-04 -
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: 2018-05-02 -
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
The aim is to facilitate and shorten the agreement process for researchers, clinics and industry by creating a standardised agreement process (prerequisites, rights and obligations of all parties involved) and in this way
Last modified: 2018-04-10 -
Development initiatives
The purpose is to evaluate the need for support and training from regional node s for researchers carrying out clinical studies with medical devices. Background The regulatory framework for
Last modified: 2018-04-10
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