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Clinical studies - step by step

Clinical studies - step by step studieprocessen studieprocessen
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    Health and medical care or clinical research?

    Compare your idea with previous research

    Search for knowledge among systematic analyses

    Search for gaps in scientific knowledge

    Use data found in registers

    Formulate the problem

    Specific rules for medicinal products or medical devices

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    The design and method of the study are important

    A research plan is necessary for ethical review applications, and functions as a handbook

    Statistical analysis plan

    Information to study participants before consent

    Find out what insurance cover is available for the study participants

    Study budget for all the costs in the project

    Is a health economics evaluation of the study needed?

    Checklist to help plan studies on human

    Specific rules for medicinal products or medical devices

  • Page contents:

    Applying for an ethical review

    Research projects in which study participants are irradiated

    Application for access to biobank samples

    Finding out what applies for handling of personal data

    Register your study before the start of the study

    Agreement on conducting clinical studies

    Specific rules for medicinal products or medical devices

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    Study participants need to give written consent

    Collecting and managing study data

    What applies for changes to the study protocol after approval?

    Specific rules for medicinal products or medical devices

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    Planning before the study begins determines how data is handled and analysed

    Studies with a confirmatory purpose

    Studies with an exploratory purpose

    Data handling when the study is concluded

    Analysis of study data

    Specific rules for medicinal prducts or medical devices

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    Writing a scientific article

    Selecting the journal

    Publishing with open access

    Publishing the results in a public database

    Informing study participants of the study results

    Specific rules for medicinal products or medical devices

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    Screening of personal data

    Specific rules for medicinal products or medical devices

Learn more about the regional nodes

The six regional nodes – one at each healthcare region – work to improve the prerequisites for conducting clinical studies and for increasing the quality of the studies.