Clinical studies - step by step

Page contents:

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
Page contents:

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?

Specific rules for medicines or medical devices
Page contents:

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
Page contents:

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

Change to an approved application, or interruption of an ongoing study
Page contents:

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
Page contents:

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
Page contents:

Screening of personal data

Specific rules for medicines or medical devices

Specific rules for medical devices

Please note that as from 26 May 2021, new rules for clinical studies involving medical devices will apply.

Registered with the Medical Products Agency

Some clinical studies involving medical devices must be registered with the Medical Products Agency. Information on how to register is available on the Medical Products Agency’s website, which also has a summary of the regulations and guidance documents that apply for studies involving medical devices.

Register a clinical study and regulations for clinical studies involving medical devices external link, opens in new window