Clinical studies - step by step

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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 medicines 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 medicines or medical devices
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Applying for an ethical review

Applying for authorisation from a radiation protection committee

Setting up a biobank or getting access to biobank samples

Finding out what applies for handling of personal data

Registering your study before the study begins

SKR and LIF – agreements and templates for clinical studies

Specific rules for medicines or medical devices

What must be submitted to the Swedish Medical Products Agency and the Swedish Ethical Review Authority?

What happens to my application?
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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 medicines 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 medicines 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 medicines or medical devices
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Screening of personal data

Specific rules for medicines or medical devices

How long should the study documentation be kept?

Specific rules for medicines

Archiving clinical trials with medicines

The research documents that clinical investigators and sponsors are obliged to draw up and store before and during a clinical medicine study shall be archived for ten years after the study has ended and the final report has been drawn up. If the clinical study is part of a marketing application, the documents shall be archived for longer than ten years. The sponsor and clinical investigator may also agree that the documents shall be archived for longer than ten years.

More information about archiving can be found on the European Medicines Agency's website (pdf, 184 kB) external link, opens in new window