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  1. File/document Development initiatives

    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

    Last modified: 2019-07-05 13.22

  2. File/document Cooperation on quality systems and work processes

    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

  3. File/document Coordination of feasibilities

    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: 2019-10-24 13.23

  4. File/document Implementation of cooperation on quality systems and work processes

    Implementation of cooperation on quality systems and work processes 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 16.19

  5. File/document Information on clinical studies on medical devices

    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

  6. File/document Mapping and needs analysis of clinical studies training

    Mapping and needs analysis of clinical studies training 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 15.35

  7. File/document National collaboration regarding monitoring services

    National collaboration regarding monitoring services The aim of the development initiative is to make it easier to monitor academically initiated multicentre studies involving several nodes and healthcare regions. A working model for co-monitoring

    Last modified: 2019-01-25 14.20

  8. File/document National data collection system

    National data collection system 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 15.33

  9. File/document National network research nurses - prestudy

    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 21.10

  10. File/document National standard R-RCT

    National standard R-RCT The 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 15.32

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  1. / English / For researchers

    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
  2. / English / For researchers / Clinical studies - step by step

    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
  3. / English / For researchers / Clinical studies - step by step / Idea

    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
  4. / English / For researchers / Clinical studies - step by step / Planning

    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
  5. / English / For researchers / Clinical studies - step by step / Application

    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: 2019-10-11
  6. / English / For researchers / Clinical studies - step by step / Execution

    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
  7. / English / For researchers / Clinical studies - step by step / Analysis

    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
  8. / English / For researchers / Clinical studies - step by step / Publication

    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
  9. / English / For researchers / Clinical studies - step by step / Archiving

    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
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  • Laws 5
  • Regulations 5
  • Study phases 1
  • Study process 9
  • Study types 5