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.
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.
- How shall the research material be archived in the long term?
- What rules apply for your research principal?
Specific rules for medicinal products or medical devices
There are specific rules to attend to conducting clinical studies on medicinal products or clinical investigations of medical devices.
Please note that from January 31, 2022, a new EU Regulation on Clinical Trials of Medicinal Products is in effect. The Swedish Medical Products Agency provides more information about Clinical Trials Regulation EU 536/2014 External link. on their website.
Archiving of clinical trials with medicinal products
The research documents that clinical investigators and sponsors are obliged to draw up and store before and during a clinical trial on medicinal products shall be archived according to different rules depending on whether the review application has been submitted according to the old regulations or according to the new EU regulation 536/2014.
For clinical trials on medicinal products conducted in accordance with national legislation and EU Directive 2001/20/EC
According to the old regulations, research documents must 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.
For clinical trials on medicinal products conducted in accordance with EU Regulation EU 536/2014
According to the new EU regulation, the sponsor and the investigator must archive the contents of the trial file for at least 25 years after the end of the clinical trial, unless a longer filing period follows from other parts of Union law. However, the study participants' patient records must be archived in accordance with national law. The research documents must be archived on such a medium that it is complete and readable throughout the period in question.
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.
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 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.
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
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: