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Dictionary:

Archiving

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When a clinical study is nearing completion, 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.

It must be possible to verify research results for ten years after project completion, and the research documents must therefore be stored in a safe and well-structured way and clearly marked during this time. Please contact your research principal to learn about the guidelines and procedures for archiving and screening that apply in your organisation.

When research is conducted at a Swedish state-operated university or HEI, the research material shall be archived there. Raw data files, ethical approval, research documentation and published results shall all be archived. Most universities and 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.

Personal data

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.

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

To consider

  • How shall the research material be archived in the long term?
  • What rules apply for your research principal?

Date created: 2017-11-14
Last published: 2018-05-24

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