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  1. File/document Development of a national website for Clinical Studies Sweden

    Development of a national website for Clinical Studies Sweden The purpose of the development initiative is to create a national website that will be the hub for Clinical Studies Sweden's digital communication. The website will serve as a national

    Last modified: 2022-02-22 13.21

  2. File/document Satellite sites – shared study work between several healthcare principals, clinics and units

    Satellite sites – enabling shared study work between several healthcare principals, clinics and units The purpose of the development initiative was to investigate whether the preconditions for conducting clinical studies in Sweden are strengthened by

    Last modified: 2021-10-25 11.01

  3. File/document Opportunities to conduct clinical research and clinical studies within primary healthcare

    Pilot study: Promote the opportunities to conduct clinical research and clinical studies within primary healthcare; roles and opportunities of the nodes The purpose was to identify activities that promote clinical research within primary healthcare.

    Last modified: 2021-10-21 14.02

  4. File/document Establishment national working group clinical studies medical devices

    Establishment of a national working group for clinical studies on medical devices The purpose was to create preconditions for Clinical Studies Sweden to meet the increased demand for support in the implementation of clinical studies on medical

    Last modified: 2021-10-21 13.58

  5. File/document National collaboration regarding monitoring services

    National collaboration regarding monitoring services The purpose was to develop a structure for collaboration in the monitoring of academically initiated multi-centre studies where several nodes or healthcare regions are involved. Background There

    Last modified: 2021-10-21 13.55

  6. File/document National network research nurses - prestudy

    National network for research nurses – pilot study The aim of the prestudy was 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: 2021-10-25 11.23

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

    Information on clinical studies on medical devices The aim was to complement the website kliniskastudier.se with neutral, quality assured information on all aspects of clinical studies on medical devices. There would also be summarised information on

    Last modified: 2021-10-21 13.48

  8. 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 was to contribute to increased quality and effectiveness in the implementation of clinical studies by establishing collaboration between the

    Last modified: 2021-10-21 13.29

  9. File/document National standard R-RCT

    National standard R-RCT The purpose was 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: 2021-10-21 13.24

  10. File/document Support measures for clinical studies on medical devices

    Support measures for clinical studies on medical devices The purpose was 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: 2021-10-21 10.54

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  1. / English / News / EMA revises guidelines for first-in-human studies

    News

    To facilitate matters for actors and reduce the risks for participants in clinical studies, the European Medicines Agency (EMA) has revised its guidelines for first-in-human studies.

    Last modified: 2022-01-03
  2. / English / News / New EU-wide law for clinical studies delayed until 2019

    News

    EMA reports that the point in time when the Clinical Trials Regulation (Regulation (EU) No 536/2014) comes into force has been delayed from October 2018 to 2019. The decision was

    Last modified: 2017-11-24
  3. / English / News / New legislation for medical devices

    News

    On Friday 26 May, two new medical technology directives come into force. The new legislation has been negotiated within the EU. The purpose of the directives adopted – one for medical devices and one for

    Last modified: 2017-11-27
  4. / 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
  5. / 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: 2022-01-03
  6. / 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: 2022-05-18
  7. / 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: 2022-04-07
  8. / 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: 2022-04-07
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  • Laws 8
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  • Regulations 8
  • Study phases 1
  • Study process 5
  • Study types 5
  • Sweden 1