Advice from BAREC regarding the retention periods for study documents in clinical research

This recommendation was endorsed by the College during the plenary meeting of 10/10/2025

Context

This short guideline provides an overview of the retention periods that apply to study documents within research projects, in accordance with applicable legal requirements. These retention periods may vary depending on the type of study involved.

General Data Protection Regulation (GDPR)

REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)

Article 5

Personal data shall be: kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the personal data are processed; personal data may be stored for longer periods insofar as the personal data will be processed solely for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) subject to implementation of the appropriate technical and organisational measures required by this Regulation in order to safeguard the rights and freedoms of the data subject (‘storage limitation’);

Clinical Trials Regulation (CTR)

REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

Article 58

Unless other Union law requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial. However, the medical files of subjects shall be archived in accordance with national law.

Medical Device Regulation (MDR)

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

ANNEX XV (CLINICAL INVESTIGATIONS)

CHAPTER III

Article 3

The documentation mentioned in this Annex shall be kept for a period of at least 10 years after the clinical investigation with the device in question has ended, or, in the event that the device is subsequently placed on the market, at least 10 years after the last device has been placed on the market. In the case of implantable devices, the period shall be at least 15 years.

In-vitro Diagnostic Regulation (IVDR)

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

ANNEX XIV (INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES)

CHAPTER II

Article 3

The documentation mentioned in this Annex shall be kept for a period of time of at least 10 years after the clinical performance study with the device in question has ended, or, in the event that the device is subsequently placed on the market, for at least 10 years after the last device has been placed on the market.

Belgian Act of 7 May 2004 on Experiments involving the human person

NL: Royal Decree (RD) – 30 JUNI 2004. – Koninklijk besluit tot bepaling van uitvoeringsmaatregelen van de wet van 7 mei 2004 inzake experimenten op de menselijke persoon voor wat betreft klinische proeven met geneesmiddelen voor menselijk gebruik.

Fr : 30 JUIN 2004. – Arrêté royal déterminant des mesures d’exécution de la loi du 7 mai 2004 relative aux expérimentations sur la personne humaine en ce qui concerne les essais cliniques de médicaments à usage humain

NL: Artikel 24

De opdrachtgever en de onderzoeker bewaren de essentiële documenten in verband met een klinische proef tot ten minste 20 jaar na de voltooiing ervan.

Fr: Article 24

Le promoteur et l’investigateur conservent les documents essentiels relatifs à un essai clinique pendant au moins 20 ans après son achèvement.

The Royal Decree of 30 June 2004 states that “essential documents related to a clinical trial must be retained for at least 20 years after its completion.” This specifically refers to clinical trials. However, since the Clinical Trials Regulation (CTR) came into force, the retention period for study documents related to clinical trials is now 25 years after the end of the clinical trial.

In other words, there is no legally defined retention period for experiments in general. Each sponsor is responsible for determining an appropriate (minimum) retention period and must specify this in the study documents, such as the protocol and informed consent form (ICF).

When setting this retention period, several motivations can be taken into account: compliance with GDPR, alignment with CTR, environmental considerations (reducing unnecessary long-term storage, especially of physical documents, contributes to a more sustainable research practice and lowers the ecological footprint), cost-efficiency (defining a realistic and justified retention period helps avoid unnecessary storage costs, particularly for paper archives or secure digital systems),…

These motivations can be balanced depending on the type of research, institutional policy, and legal context. Ultimately, transparency and clarity in defining the chosen retention period are key.

Summary

Study type or applicable law	Information about retention period
GDPR	No longer than is necessary for the purposes for which the personal data are processed
CTR	At least 25 years after the end of the clinical trial.
MDR	For a period of at least 10 years after the clinical investigation with the device in question has ended for a period of at least 10 years after the last device has been placed on the market. Implantable devices: at least 15 years.
IVDR	For a period of at least 10 years after the clinical investigation with the device in question has ended for a period of at least 10 years after the last device has been placed on the market.
Experiments	No legally defined retention period