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  1. File/document CRF

    CRF Case Report Form. A case report form collects all the data on a single study participant requested in the study protocol. Subscribe Contact

    Last modified: 2019-02-27 19.55

  2. File/document CRO

    CRO Clinical Research Organisation. Independent contract research organisation that carries out whole or parts of clinical studies on assignment from a sponsor. Subscribe Contact

    Last modified: 2019-02-27 19.56

  3. File/document Data management

    Data management Handling of data within a clinical study, for example. Subscribe Contact

    Last modified: 2019-02-27 19.58

  4. File/document DMP

    DMP Data Management Plan. A document on data handling activities, systems, data flows and responsibilities in a clinical study. Subscribe Contact

    Last modified: 2019-02-27 19.58

  5. File/document Double blind

    Double blind A study where neither the investigator nor the study participants know which therapy is given to a specific participant. Subscribe Contact

    Last modified: 2019-02-27 20.00

  6. File/document DSMB

    DSMB Data Safety Monitoring Board. An independent group of experts who monitor the safety of study participants and the effectiveness of a therapy during an ongoing clinical intervention study. Subscribe Contact

    Last modified: 2019-02-27 19.59

  7. File/document DSUR

    DSUR Development Safety Update Report. Annual safety report that summarises side effect reports. Completed by the sponsor. Subscribe Contact

    Last modified: 2019-02-27 20.00

  8. File/document ECRIN

    ECRIN Public non-profit organisation that links together scientific partners and networks across Europe to facilitate multinational clinical research. Subscribe Contact

    Last modified: 2019-02-27 20.01

  9. File/document Effect variable

    Effect variable Something that is being registered and measured within the framework of a clinical study. Subscribe Contact

    Last modified: 2019-02-27 20.02

  10. File/document End of trial notification

    End of trial notification Shall be sent to the Medical Products Agency no later than 90 days after the conclusion of a medicine study. Subscribe Contact

    Last modified: 2019-02-27 20.02

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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: 2022-01-03
  3. / 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: 2021-09-03
  4. / 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: 2022-01-03
  5. / 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: 2021-09-03
  6. / 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
  7. / 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
  8. / 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
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  • Regulations 8
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  • Study process 5
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  • Sweden 1