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 notification or 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?

Open access and impact factors

Eva Hessman and Helen Sjöblom work at the University of Gothenburg library. In the interview below, they tell us what you might think about when publishing the results of a clinical study in a scientific periodical.

How do you find a periodical for publishing the results of a clinical study?

There is no shortcut to finding solely clinical periodicals; instead, the same method applies here as for other types of periodicals. There are several services that create proposals based on your text, often the abstract and title of the article. These search services may be neutral, but the major publishers also have corresponding services.

You can also conduct a subject search, using one of the large citation databases such as Scopus or Web of Science. When you have completed your search, you can see which periodicals have published the largest number of articles on your subject. Do this by either checking “Sources/Source title” in the left margin under “Refine results”, or by using the databases’ “Analyze results” function.

What do you need to think about when choosing a periodical?

An important aspect of the choice of periodical is, of course, how your research results are disseminated.

Can the article be found using a search on PubMed, for example? Ulrichsweb lists periodicals and the databases External link, opens in new window. where they are indexed.
Is is important that you publish in a prestigious periodical? Incites lists periodicals and their impact using impact factors External link, opens in new window..
Is it important that as many as possible can access and read your article in full text format? Then you should choose an open access periodical. Many higher education institutions have agreements that give discounts on publishing with several open access publishers. Directory of Open Access Journals (DOAJ) lists quality-controlled open access periodicals External link, opens in new window..

You can also use the website Think Check Submit to safeguard the quality of periodicals External link, opens in new window..

What help can a librarian provide when you want to publish a scientific article?

We can help you to navigate among all the sources listed above. We know about things like databases, the requirements of research funding bodies, impact and publication routes, and are keen to provide advice and guidance.