Archiving
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.
- Archiving in the research process
- Public documents must be archived
- Where is research material archived?
- Digital archiving
- Plan archiving at an early stage
- Specific requirements for certain research areas
- Screening of personal data
- Points to consider
- Specific rules for medicinal products and medical devices
- Archiving of clinical trials of medicinal products
- Related information about ATMP
Archiving in the research process
When research material, data and documentation are to be preserved in the long term, both structure and planning are required. Below you will find information on what applies to public documents in research and what you need to consider when a clinical study is completed.
Public documents must be archived
Documents produced as part of the research activities of higher education institutions and other public agencies constitute research material. Most of this material are public documents that must be archived according to the Archives Act (SFS 1990:782).
Some documents must be screened (disposed of) after a specified time period, and some documents must be preserved indefinitely (“forever”).
Where is research material archived?
When research is conducted at a Swedish state-operated HEI, the research material shall be archived there. This includes, for example:
- raw datafiles
- ethical approval
- research documentation
- published results
Most higher education institutions have personnel who can provide both practical support and advice. Some non-state operated research principals are also subject to the same archiving and screening requirements.
Digital archiving
When digitally archiving, it is important to note that digital documents regularly need to be:
- converted (saved in a newer format)
- migrated (transferred from one medium to another)
Therefore, the readability of digital files should be checked regularly.
Plan archiving at an early stage
A strategy for screening and archiving should be included already in the planning of a clinical study.
Contact your research principal to learn about the guidelines and procedures for archiving and screening that apply in your organisation.
Specific requirements for certain research areas
Some research fields are subject to more specific regulations, such as clinical trials of medicinal products and clinical trials of medical devices.
Additional information can be found further down on this page.
More information about the Archives Act is available on the Swedish National Data Service website.
Screening of personal data
Screening means that public documents are discarded and/or destroyed. In principle, it is prohibited to screen public documents unless there is support in a screening regulation, that is, an established right to screen.
The removal of material that does not constitute public documents is referred to as purging.
Personal data may only be processed for as long as it is necessary for the original purpose. When the data is no longer needed, it must be removed. However, applicable regulations and requirements regarding archiving and screening must always be complied with.
Information on screening is available on the Swedish National Archives website.
Information on screening (in Swedish), Swedish National Archives website External link.
Points to consider
- How should the research material be preserved in the long term?
- Which rules apply at your research principal?
Specific rules for medicinal products and medical devices
There are specific rules to follow when it comes to clinical trials of medicinal products and clinical investigations of medical devices.
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.
Medical devices in the EU are divided into two regulatory categories, each following different regulations. For medical devices, the EU Regulation on Medical Devices (MDR) applies. New regulations came into effect within the EU from May 26, 2021, and additional regulations apply in Sweden from July 15, 2021.
What shall be archived?
In general, the sponsor of clinical investigations of medical devices shall archive items such as application documents for the permit to conduct the study, information about the product characteristics and risk management documentation. The sponsor shall also archive data in the form of CRFs, summary raw data files, data analyses conducted and result reports. All principal investigators in the study shall archive trial files and source data generated at the own trial location. Unless otherwise has been specifically approved by the regulatory authorities, the investigator shall only provide pseudonymised information to the sponsor, and never information that discloses the study participants’ identity, such as signed consent forms or code keys. More information on the documents to be held by the investigator and sponsor respectively following conclusion of the study is available in ISO 14155:2020, Annex E.
Standard ISO 14155:2020, SIS' website External link.
How long should the study documentation be kept?
The investigator shall then archive their documentation in readable format. There is no statutory regulation of how long the investigator’s documentation in a medical device study shall be archived; instead, this follows from the rules applicable to the operation the investigator works in. However, the main rule is that the archiving period is never shorter than ten years. The sponsor and investigator may also agree on a longer archiving period if suitable.
The sponsor shall archive their documentation for no less than ten years after the clinical investigation of the medical device has been conducted. If the product is launched on the market, the documentation must be kept for at least ten years after the last product has been sold on the market. For implants, the documentation shall be archived for 15 years.
Medical devices for in vitro diagnostics (IVDR)
Medical devices in the EU are regulated and divided into two categories, each following different regulations. For in vitro diagnostic medical devices, the EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) applies. New regulations will be in effect within the EU from May 26, 2022.
What shall be archived?
In general, the sponsor of a clinical performance study or other performance studies must file, among other things, application documents for a permit to carry out the study, information about the product's properties and risk management documentation. The sponsor must also archive data in the form of completed CRFs, compiled raw data files, completed data analyzes and performance reports. All responsible testers in the study must archive the sample binder and source data generated at their own test site. Unless otherwise specifically approved by regulatory authorities, the examiner should only provide pseudonymous information to the sponsor, never information that reveals the identity of the study participants such as signed consent forms or code keys. More information about which documents must be available from the examiner and sponsor after completion of the study can be found in ISO 20916: 2019.
The standard ISO 20916:2019 , SIS' website External link.
How long should the study documentation be kept?
It is not regulated by law for how long the examiner's documentation in a clinical performance study or other performance studies must be preserved, but follows from the rules that apply to the activity to which the examiner belongs. As a general rule, the archiving period should not be shorter than ten years. Sponsors and testers can also agree on a longer filing period if appropriate. The examiner must archive his documentation in legible condition.
The sponsor must keep his study documentation for at least ten years after the clinical trial has ended, if the product is placed on the market, the documentation must be kept for at least ten years after the last product has been placed on the market.
Related information about ATMP
ATMP (Advanced therapy medicinal products)
Advanced therapy medicinal products (ATMP) are human medicines, based on genes, tissues or human cells. They offer ground-breaking new opportunities for the treatment of diseases and injuries. More information about advanced therapies:
- For guide/templates and regulatory guide, ATMP project website External link.
- Classifications, regulatory information, European Medicines Agency website External link.
- About the product area: advanced therapy and joint links (in Swedish), Swedish Medical Products Agency’s website External link.
- E-course: Introduction to advanced therapies (in Swedish), Swedish Academy of Pharamceutical Sciences website External link.
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