Archiving
When a clinical study is completed, the research material, data and documentation must be prepared for long-term preservation. Structured archiving makes it possible to review and verify the research results and to conduct further analyses.
- Archiving in the research process
- Official documents must be archived
- Archive research material
- Digital archiving
- Plan archiving at an early stage
- Specific requirements in certain areas of research
- Disposal of documents containing personal data
- Specific requirements for medicinal products and medical devices
- Archiving of clinical trials of medicinal products
- Archiving documentation from a clinical investigation of a medical device
- Archiving documentation from a performance study of an in vitro diagnostic medical device
- Related information about Advanced therapy medicinal products (ATMPs)
- Advanced therapy medicinal products (ATMPs)
Archiving in the research process
Long-term preservation of research material, data and documentation requires structure and planning. This page provides information about the requirements for official documents in research and what to consider when completing a clinical study.
Official documents must be archived
Documents created through research activities at universities, higher education institutions and other government agencies constitute research material. Most of these documents are official documents and must be archived in accordance with the Swedish Archives Act (1990:782).
Some documents must be disposed of after a specified period, while others must be preserved permanently.
Archive research material
When research is conducted at a Swedish government university or higher education institution, the research material must be archived there. This includes, for example:
- raw data files
- ethical review decisions
- research documentation
- published results
Most higher education institutions have staff who can provide practical support and advice on archiving. Some research principals that are not government agencies may also be subject to requirements concerning archiving and disposal.
Digital archiving
For digital archiving, file formats and storage media must be kept up to date over time. Digital documents may need to be:
- converted into new file formats
- migrated between different storage media
It is therefore important to check regularly that the documents remain readable.
Plan archiving at an early stage
A strategy for archiving and disposal should be developed when the clinical study is being planned.
Contact the organisation responsible for your research to find out which guidelines and procedures for archiving and disposal apply within your organisation.
Specific requirements in certain areas of research
Specific archiving requirements apply to certain types of clinical studies. These include clinical trials of medicinal products and clinical investigations of medical devices.
Further information is available under the headings for medicinal products, medical devices under the MDR and in vitro diagnostic medical devices under the IVDR further down this page.
The Swedish Archives Act, Swedish National Data Service website External link.
Disposal of documents containing personal data
Disposal means the destruction of official documents. As a general rule, official documents may not be disposed of unless this is supported by applicable disposal regulations or a formal disposal decision.
Removing material that does not constitute official documents is referred to as clearing out.
Personal data may only be processed for as long as necessary for the original purpose. When the data are no longer needed, they must be removed. However, applicable requirements concerning archiving and disposal must also be followed.
Disposal of official documents, Swedish National Archives website External link.
Points to consider before archiving
When the study is completed, you need to ensure that the research material, data and documentation are preserved in accordance with the applicable requirements and your organisation’s procedures.
- Which research material must be preserved?
- How and where should the material be preserved in the long term?
- Which rules and procedures apply within the organisation responsible for the research?
- Are there documents that must be disposed of after a specified period?
- Is the study subject to specific archiving requirements?
Specific requirements for medicinal products and medical devices
Specific archiving requirements apply to:
- clinical trials of medicinal products
- clinical investigations of medical devices
- performance studies of in vitro diagnostic medical devices
Under the relevant headings below, you will find information about which documents must be archived, who is responsible for archiving them and how long the documentation must be retained.
Archiving of clinical trials of medicinal products
Research documents produced by the investigator and the sponsor before and during a clinical trial of a medicinal product must be archived. The requirements for archiving differ depending on which regulatory framework applies to the trial.
EU-regulation EU 536/2014
Clinical trials of medicinal products conducted in accordance with EU Regulation (EU) 536/2014 must comply with the following requirements:
- The sponsor and the investigator must archive the contents of the Trial Master File for 25 years after the clinical trial has ended, or longer if required under Union law.
- Patient medical records of trial participants must be archived in accordance with national legislation.
- Documents must be archived in a way that ensures they remain complete and legible throughout the entire retention period.
More information is available on the Swedish Medical Products Agency’s website.
Clinical Trials Regulation EU 536/2014, Swedish Medical Products Agency website External link.
Previous regulatory framework (EU Directive 2001/20/EC)
For clinical trials of medicinal products that were completed before 31 January 2025 and conducted under national legislation and EU Directive 2001/20/EC, the following applies:
- Documents must be archived for 10 years after the trial has ended and the final study report has been completed.
- If the trial forms part of an application for marketing authorisation, the documents must be archived for longer than 10 years.
- The sponsor and the investigator may also agree on a longer retention period than that required by law.
Archiving documentation from a clinical investigation of a medical device
Clinical investigations of medical devices are governed by the EU Medical Devices Regulation (EU) 2017/745 (MDR), which came into effect on 26 May 2021.
What should be archived?
The sponsor of a clinical investigation of a medical device is responsible for archiving key study documents, including:
- application documents for authorisation of the clinical investigation
- information about the device’s characteristics
- risk management documentation
- Case Report Form (CRF) data
- aggregated raw data files
- completed data analyses
- reports of the results.
Investigators at each investigational site are responsible for archiving the Investigator Site File and all source data generated at their site.
Unless specifically approved by the regulatory authorities, investigators should only provide pseudonymised information to the sponsor. They must never provide information that can identify individual study subjects, such as signed consent forms or code keys.
Further guidance on the documents that sponsors and investigators are required to archive is provided in Annex E to ISO 14155:2026.
ISO 14155:2026, Swedish Institute for Standards website External link.
How long should the documentation be retained?
The sponsor shall retain the documentation from the clinical investigation in a legible condition for at least ten years after the investigation has ended.
If the device is placed on the market, the documentation shall be retained for at least ten years after the last device has been placed on the market.
For implants, the documentation must be retained for 15 years.
Medical devices for in vitro diagnostics (IVDR)
Archiving documentation from a performance study of an in vitro diagnostic medical device
Performance studies of in vitro diagnostic medical devices are governed by the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which came into effect on 26 May 2022.
What should be archived?
The sponsor of a clinical performance study is responsible for archiving key study documents, including:
- application documents for authorisation of the study
- information about the device’s characteristics
- risk management documentation
- Case Report Form (CRF) data
- aggregated raw data files
- completed data analyses
- reports of the results.
Investigators at each study site are responsible for archiving the Investigator Site File and all source data generated at their site.
Unless specifically approved by the regulatory authorities, investigators should only provide pseudonymised information to the sponsor. They must never provide information that can identify individual study subjects, such as signed consent forms or code keys.
Further guidance on the documents that sponsors and investigators are required to archive is provided in ISO 20916:2024.
ISO 20916:2024, Swedish Institute for Standards website External link.
How long should the documentation be retained?
The sponsor shall retain the documentation from the clinical performance study for at least ten years after the study has ended.
If the device is placed on the market, the documentation shall be retained for at least ten years after the last device has been placed on the market.
Related information about Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs) are biological medicinal products based on genes, cells or tissue engineering. ATMPs are regulated by common EU legislation supplemented by Swedish legislation.
The links below provide further information, regulatory guidance, templates and training.
- Advanced therapy medicinal products, Swedish Medical Products Agency website External link.
- Guides, templates and regulatory support, ATMP Sweden website External link.
- ATMP classification and regulatory information, European Medicines Agency website External link.
- Online course: Introduction to advanced therapies, Swedish Academy of Pharmaceutical Sciences website External link.
Research support for clinical trials involving advanced therapy medicinal products
Contact your regional node within Clinical Studies Sweden to find out what research support is available for your study.
Contact your regional node within Clinical Studies Sweden External link.
Published: