How to manage your records and data at the end of a study?
At the end of a study, sponsors are faced with several options when deciding what to do with their data, and where it should be kept.
This is a good place to start this guide, as the end of study period is the time when archiving considerations are most pressing. At Arkivum, we would recommend making these plans as early as possible to reduce the risk of data loss and/or documentation issues, which could cause issues when gaining approvals with regulators. That said, we appreciate that early preparation may not always be the case.
It is also worth noting at this stage, that EU CTR states that sponsors must appoint individual(s) who are responsible for the archive. We would highly recommend that this individual is appointed as soon as possible, to provide internal clarity on who owns the long-term retention of records and data.
Adopting a risk-based approach
Taking a risk-based approach in the context of maintaining data integrity for the entire retention period, can be an extremely useful tool when planning what to do with your data at the end of a study. Not only that, but a risk-based approach can provide an excellent framework by which to communicate the value of investing in appropriate solutions.
By mapping the likelihood of data integrity issues over the entire retention period to the potential impact of those issues can act as a driving force to follow best practice.
Access our risk-based mapping tool by clicking on the button below.
End of Study Approaches
In our experience, we have seen four main approaches for retaining data and records at the end of a study. Click on the links below to find out more about the considerations and challenges for each approach...and most importantly why we believe there is only one compliant answer.
Storing data on physical media (e.g. CDs, USBs and external hard drives)
Physical storage media is perhaps the riskiest approach to take when retaining data. Not only do you have worry about how to maintain the data for that period of time, you must also maintain the hardware that it’s stored on. Additionally it’s hard to access data on these types of media, significantly hampering an organisations ability to maintain digital content in a usable form.
Find out more about using physical media by clicking on the button below.
Storing data on file sharing sites such as SharePoint
Storing data on file sharing sites including SharePoint, Dropbox or OneDrive presents several challenges to retaining data for decades. While this overcomes many of the access challenges seen in some of the other approaches, there should be significant concerns raised about using these tools as a digital archive for GCP records and data.
File sharing sites have not been designed to archive and preserve data. Any safeguarding or preservation activities (which we’ll cover later in this guide) will therefore need to be conducted manually, taking significant time and resources away from other parts of the organisation.
It's worth noting that some organisations also consider the use of content management platforms such as Box or Egnyte. These platforms face similar challenges to file sharing platforms when it comes to archiving and preserving data for the long-term.
Find out more about using file sharing sites by clicking on the button below.
Retaining data within eClinical source systems (e.g. TMF, eCRF, eCOA, ePRO solutions)
Keeping data within eClinical systems is the simplest approach, albeit largely only in the short term. While the risk to data loss, corruption and obsolescence is relatively small in the first couple of years of retention there are serious risks to consider by leaving digital assets within eClinical systems.
As with file sharing platforms, they have not been designed to safeguard and preserve data for decades. Other challenges also include the risk of becoming locked into the systems, and spiralling costs over the entire retention period.
Find out more about retaining data within eClinical source systems by clicking on the button below.
Consolidating all trial records and data into a centralised digital archive
Arkivum would highly recommend consolidating all trial records into a single repository at the end of study. This ensures that the data can be safeguarded and preserved as long as it is needed, and most importantly inline with regulations such as EU CTR.
We typically find that it is much easier to manage access and retention requirements within one system vs. multiple. And as an added benefit, it is typically much more cost effective than many other options available to sponsors.
On the next page we will explore best practice approaches every digital archive should have.