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.
Public documents must be archived
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. 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.
When digitally archiving, it is important to note that digital documents regularly need to be converted (saved in a newer format) and migrated (transferred from one medium to another). Therefore, the readability of digital files should be checked regularly.
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 clinical trials on medicinal products. Additional information can be found further down under the Medicinal products-tab.
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.
Personal data, for example, 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.
Information on screening (in Swedish), Swedish National Archives website
External link.
To consider
- How shall the research material be archived in the long term?
- What rules apply for 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.
Please note that since January 31, 2022, a new EU-wide regulation on clinical trials of medicinal products has applied. The Swedish Medical Products Agency has more information about this on their website:
Clinical Trials Regulation EU 536/2014 | Swedish Medical Products Agency, Läkemedelsverket External link.
Archiving of clinical trials of medicinal products
The research documents that the investigator and sponsor are required to prepare and store before and during a clinical trial of medicinal products must be archived according to different rules. This depends on whether the trial application was submitted under the previous regulatory framework and completed before January 31, 2025, or according to the new EU Regulation EU 536/2014.
Clinical trials of medicinal products conducted under EU-regulation EU 536/2014
According to the new EU Regulation, the sponsor and investigator are required to archive the contents of the trial master file for at least 25 years after the end of the clinical trial, unless a longer archiving period is required by other parts of EU law. However, patient records of the trial subjects should be archived in accordance with national law. The documents must be archived on a medium that is complete and legible for the entire period concerned.
For information on archiving according to the new EU regulation, see the Swedish Medical Products Agency website.
Clinical Trials Regulation EU 536/2014 | Swedish Medical Products Agency | Läkemedelsverket External link.
Clinical trials of medicinal products completed before January 31, 2025, and performed in accordance with national legislation and EU Directive 2001/20/EG
Shall be archived for 10 years after the trial has ended and the final report has been prepared. If the clinical trial is part of a marketing authorization application, documents must be archived for longer than 10 years. The sponsor and investigator may also agree to archive the documents for more than 10 years.
For information on archiving under the previous regulation, see the Swedish Medical Products Agency website.
Clinical trials and Good Clinical Practice – according to Directive 2001/20/EC | Swedish Medical Products Agency | Läkemedelsverket External link.
Medical devices, EU regulation MDR
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, EU regulation 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.
Links and related information
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 therapy:
For guide/templates and regulatory guide, ATMP project website External link.
Classifications, regulatory information, European Medicines Agency website External link.
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