European Union rules require clinical trial data to be kept for 25 years.
New European Union legislation that requires clinical trial master file data to be kept for 25 years from study completion requires actions from sites – including those based in the United States. Of critical importance to sites, the EU Clinical Trial Regulation 536/2014 (CTR) applies to all new trials from January 31, 2023.
“It may come as a surprise to some, but the new legislation affects all trials, and not just those in the EU,” says David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Research Compliance & Integrity, HCA Healthcare. “The reason is simple – the rules apply to trials for any drug that will be submitted for registration in the EU. This includes virtually all new therapies, and although not directly regulated, non-EU sites are experiencing the obligations passed down to them contractually.”
There are clear benefits from the new legislation for sponsors, who can apply for authorization to run a clinical trial in all EU countries through a single application, rather than applying separately to each country as in the past. However, the data must be readily available to regulators upon request.
“Obligations under the CTR are trickling down to clinical research sites around the globe,” explains Vulcano. “The 25-year record retention requirement for investigators is probably the most significant. Sites, sponsors, and CROs all need to be fully educated on the implications of this mandate. It’s not just a matter of putting the data onto a CD and filing it away for 25 years. This obligation – and the associated unpredictability and business risk – cannot be casually passed to sites.”
“Sites have several options,” continues Vulcano. “They can accept this obligation through a combination of storing it themselves and managing third-party vendors to do so – typically in return for a one-time fee from the sponsor. Alternatively, they can negotiate, as permitted by the regulations, to transfer the archives and its ownership to the sponsor as soon as reasonable. Sites themselves are not in the business of long-term archiving and thus arguably not the best solution for sponsors.”
2023 U.S. Regulatory Update
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Vendors are better prepared to handle data storage than sites, with potential for specialty record vendors to emerge with turnkey solutions to alleviate the burden for sponsors and sites. At present, most vendors have archiving services for specific elements of the trial records, such as investigational review board management systems, eConsent, or eSource, meaning that multiple vendors would be needed to deal with the fragmented inventory of trial data. Added to this, there may be paper records that must also be archived.
“Sites and sponsors alike should look closely at the option of returning data to sponsors after a reasonable length of time,” says Vulcano. “The sponsor could then add the data into the system that is already used to store other information on the particular therapy. This avoids the risks to the sponsor related to changes of ownership among sites and vendors.”
“To date, this challenge has not been fully appreciated by all players in the clinical trials enterprise,” Vulcano concludes. “Looking ahead, stakeholders should consider coming together to determine a path towards a standard approach for contracting, taking into account factors such as risks, likely costs, and technology changes, to meet this long-term commitment.”
Author: Jill Dawson
