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  1. File/document Declaration of Helsinki

    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

  2. File/document Study types

    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

  3. File/document Participating in study

    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

  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 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

  8. 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

  9. File/document National website for clinical studies

    National website for clinical studies The 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 14.45

  10. File/document Research Subject Survey

    Research subject survey The aim is to develop a national research subject survey. The results of compiled surveys can provide statistical data for improvement work at research clinics and enable adaptations of studies according to the participants'

    Last modified: 2019-02-15 14.37

Search this site

Your search resulted in 8 hits

  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 / 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
  3. / 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
  4. / English / News / EMA revises guidelines for first-in-human studies


    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: 2017-11-24
  5. / English / News / New EU-wide law for clinical studies delayed until 2019


    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
  6. / English / News / New legislation for medical devices


    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
  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: 2020-03-17
  8. / 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: 2020-04-06
Filtrera resultatet


  • Information 5


  • News 3


  • Laws 8
  • Outlook 2
  • Regulations 8
  • Study phases 1
  • Study process 5
  • Study types 5
  • Sweden 1