Data retention periods for medical research
Below you find an overview of the retention periods required in the Netherlands for data collected in the context of medical research involving human subjects.
Research with medicinal products
For data collected in the context of research with a medicinal product a minimum retention period of 25 years is required. This requirement is laid down in article 58 of the EU Clinical Trial Regulation 536/2014 (CTR). CCMO considers this retention period to be acceptable in anticipation of the CTR coming into force.
For data collected in the context of medical research with advanced therapy medicinal products (ATMPs) a minimum retention period of 30 years is required. This requirement is laid down in article 6.37 of the Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products.
Research with medical devices
A minimum retention period of 10 years is required for the documentation of research with medical devices after the end of the study with the device. When the medical device is put on the market, the minimum retention period of 10 years starts when the last device has been put on the market.
A minimum retention period of 15 years is required for research with an implantable medical device.
These retention periods have been laid down in Annex XV Chapter III section 3 of the EU Medical Device Regulation 2017/745 (MDR).
Other research subject to WMO
No fixed retention period has been laid down in legislation for data collected in the context of other research subject to the Dutch Medical Research Involving Human Subjects Act [Wet medisch-wetenschappelijk onderzoek met mensen, WMO]. Provided this period is substantiated in the research protocol, CCMO considers a retention period of 15 years acceptable. If a shorter or longer retention period is sufficient for a specific study, CCMO considers this substantiated retention period as the most suitable.
Data retention period at study site and at sponsor
Essentially, the data retention periods at the study site and at the sponsor are the same. If these retention periods differ, the subject information sheet template offers the possibility to state both retention periods separately. The protocol should contain a further specification of the data to be stored at the study site and at the sponsor during the retention period. You are not required to include these details in the subject information sheet.