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Clinical studies - step by step

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

    Särskilda regler för läkemedel och medicinteknik

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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?

    Specific rules for clinical trials with medicines or medical devices

    Särskilda regler för läkemedel och medicinteknik

  • 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

    Specific rules for clinical trials with medicines or medical devices

    SKL and LIF – agreements and templates for clinical studies

    Särskilda regler för läkemedel och medicinteknik

  • 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 clinical trials with medicines or medical devices

    Särskilda regler för läkemedel och medicinteknik

  • 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

    Särskilda regler för läkemedel och medicinteknik

  • 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

    Särskilda regler för läkemedel och medicinteknik

  • Page contents:

    Screening of personal data

    Specific rules for clinical studies using medicines

    Särskilda regler för läkemedel och medicinteknik

Clinical studies - step by step

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 conducting a clinical study. The process and the regulatory framework vary depending on the type of study you are carrying out. Some parts of the process are general, others are specific for a certain type of study.

Idea

At the idea phase, you compare your idea with previous research in the area and formulate the research question, which determines the type of study to be carried out, and the type of data to be collected.

Planning

Once the problem formulation is completed, the planning of your clinical study starts. This includes writing a research plan, producing information and arranging insurance for the study participants, and drawing up a study budget. For clinical trials with medicines and medical devices, there are special rules concerning the allocation of responsibility and data handling.

Application

Once the research plan is completed, you must apply for authorisation from an ethical review board and in many cases also from the Medical Products Agency.

Execution

Once all authorisations required have been obtained, recruitment of study participants and collection of data begins. For clinical trials with medicines and medical devices, there are special rules concerning study folders, monitoring and reporting.

Analysis

Once all the data have been collected, the study results are analysed and the outcome compared with the original question.

Publication

The results of your study may be disseminated to research colleagues, healthcare personnel and the general public with the help of scientific publications.

Archiving

Once your clinical study has been completed, research material including data and documentation need to be prepared for long-term storage and archiving.

Study types

On the website, clinical studies are divided up into the subsidiary groups:

  • clinical trials
  • observation studies
  • diagnostic studies
  • qualitative studies

Specific rules for clinical trials

Several of the steps in Clinical studies – step by step have specific instructions for clinical trials with medicines or medical devices.

You can find advice on how to determine whether your medicine study is a clinical trial or an observation study on the Medical Product Agency's websiteexternal link, opens in new window.

All clinical trials with medical devicesexternal link, opens in new window involving non-CE marked medical devices or medical devices that are CE marked for other use than that intended in the study shall be notified to the Medical Products Agency.


Skapad: 2017-11-07
Senast uppdaterad: 2017-12-20 

Contact

Office for Clinical Studies, Swedish Research Council

Östra Hamngatan 26
SE-411 09 Göteborg

 

Phone (Swedish Research Council, switchboard):
+46 (0)31 757 41 75

E-mail: kliniskastudier@vr.se

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Clinical Studies Sweden - a collaboration between The Swedish Research Council and the Swedish Association of Local Authorities and Regions.