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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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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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Information on clinical studies on medical devices 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 14.19
Search this site
Your search resulted in 9 hits
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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 -
For researchers
Once the problem formulation is completed and you know what questions are to be answered and what data need to be collected and analysed, the planning of your clinical study starts. Page contents: Page contents: The design and method of the
Last modified: 2019-09-11 -
For researchers
Once the approvals required for your clinical study have been obtained, the practical work on the study can start. Page contents: Page contents: Study participants need to give written consent Collecting and managing study data What applies
Last modified: 2019-09-11 -
For researchers
When you have an idea and want to find out whether it is sound, it is a good idea to start by making an inventory of what is already documented in the area. By carrying out a literature search and a review of registers and databases, you can map
Last modified: 2019-09-11 -
For researchers
It is easier to apply for authorisation for a clinical study if thorough preparations have been made and there is a well worked out and detailed research plan. Once the research plan is completed, you must apply for authorisation from the
Last modified: 2019-09-11 -
For researchers
It is a good idea to consult a statistician already during the planning phase to enable the production of correctly analysed data and publication of the result. Early preparation is crucial for producing a good study design, the correct
Last modified: 2019-09-11 -
For researchers
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 -
For researchers
The pages in “Clinical studies – step by step” are aimed in the first instance at persons working within healthcare and research who want to know more about the study process, and what needs to be considered when
Last modified: 2019-09-11 -
For researchers
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
