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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

Archiving

Read time 1,5 min

When a clinical study is completed, research materials including data and documentation need to be prepared for long-term storage. It is important to research documents are stored and archived in a structured way in order to enable scrutiny and verification of research findings, and to repeat analyses.

All types of documents produced as part of the research activities of HEIs and other public agencies constitute research material, and most of these are public documents that must be archived according to the Archives Act (SFS 1990:782)(in Swedish)external link, opens in new window. Some documents shall be screened after a specified time period, and some documents shall be preserved “forever”.

When research is conducted at a Swedish state-operated HEI, the research material shall be archived there. Raw datafiles, ethical approval, research documentation and published results shall all be archived. Most HEIs have personnel who can provide both practical help and advice. There are several non-state operated research principals covered by the same archiving and screening requirements, such as Chalmers University of Technology and Jönköping University.

A strategy for screening and archiving should be included already in the planning of a clinical study; please contact your research principal to learn about the guidelines and procedures for archiving and screening that apply in your organisation.

For some research fields, there may be more specific regulations, such as for medicine studies, where the European Medicines Agency's regulations (pdf, 184 kB)external link, opens in new window shall be followed.

The website of the Swedish National Data Service has further information on archivingexternal link, opens in new window and the Archives Act (in Swedish).

Screening of personal data

Screening means that public documents are discarded and/or destroyed. Destruction of public documents is, in principle, prohibited, unless it is supported by a screening regulation; that is to say there is a screening right. When data that are not public documents are removed, this is known as purging.

There are rules that may require you to screen personal data already while your clinical study is in progress. For example, personal data may only be handled for as long as necessary to fulfil the purpose of the handling. Personal data that is no longer needed shall be removed, but regulations and archiving and screening requirements must be complied with and fulfilled.

More information on screening can be found on the website of the Swedish National Archives (in Swedish)external link, opens in new window.

Specific rules for clinical studies using 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

Särskilda regler för läkemedel och medicinteknik


Skapad: 2017-11-14
Senast uppdaterad: 2018-12-14 

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.