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). 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) shall be followed.
The website of the Swedish National Data Service has further information on archiving and the Archives Act (in Swedish).
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.
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.
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
Would you like to subscribe to news, good examples or calendar events from clinicalstudies.se?