Taking a risk-based approach to archiving the eTMF

In my recent webinar on 8 tips to retaining data for +25 years, I talked about taking a risk-based approach to digital preservation. It’s a topic that we see applied to many facets across organisations today, including the management of clinical trial data throughout its lifecycle. 

A risk-based approach is an effective method to support critical business decision making, particularly (although I’d argue not exclusively) for risk orientated organisations. It can help to frame discussion on subjects which have a low level of organisational expertise and understanding. 

It’s why I think it can be an incredibly effective tool for managing the retention of the eTMF for +25 years in line with regulations such as EU Regulation 536/2014. 

 In the webinar, I posed three initial questions as examples of what you could ask. I want to take a look at possible responses to each, for sponsors retaining eTMF records. 

What would happen if we could no longer access a particular dataset? 

This is perhaps the easiest one to answer – if for example, for whatever reason a sponsor could not in future access the eTMF during an inspection, then they would be liable for fines, delays to manufacturing and reputational damage.  

It may sound simple, but it’s a fantastic starting point for any discussion about how to approach record retention. We’ve quite clearly established why we need to ensure these records are accessible in future. 

 This question can also be used to tease out additional reasons to ensure long-term access. We see sponsors require long-term access for a whole host of reasons including working on new formulations, repurposing approved drugs or informing future trial design. 

What are the risks involved of leaving it where it is? 

This is a more challenging to question to answer, but the process of simply asking it can generate follow on questions to gain a clearer understanding (as we’ll see in the next question). 

The important point here is to ask risk-based questions, to challenge potential assumptions held by parts of the organisation. From our experience, many within an organisation wouldn’t be able to fully answer this question, but likely assume that long-term digital records are safe left where they are. 

 Finding answers to these will help to understand the risks involved, and inform planning and decision making going forward. 

What are the risks of the storage failing? 

As mentioned earlier, one question can, and probably should, lead onto to another. A basic example would be to simply understand how likely the storage your using could fail. Even today, we see examples of data being stored on physical media such as CDs and hard drives, all which are at increasing risk of failure over time. 

If we take the example of the eTMF, often sponsors leave the data within an eTMF system (linking into the previous question posed). We’ve previously blogged about the challenges this presents, but to summarise here, every sponsor should be asking questions like; 

• How easy will it be to migrate the data out of the system in future? 
• How will we manage access over 25 years? 
• How will we check that integrity is maintained?
• Will we create copies of each record in long-term formats?

By running through these three questions, clinical trial sponsors should get a much clearer idea of the risks of their current approach, and most importantly, an idea of how to proceed. This will ideally result in an inspection prepared repository for your long-term eTMF records. 

Summary 

I hope that this post has provided some useful insight into how a risk-based approach can support successfully retaining the eTMF for +25 years. I think it is, and will continue to be, a fantastic tool to frame internal discussions on long-term data management. 

Before I sign off, I wanted to share two links to useful tools which provide a much more detailed exploration of risk within the context of digital preservation. 

The first is the Digital Preservation Coalition’s (DPC) guide to risk management. This online tool is part of their executive guide to digital preservation, and provides a range of risk statements with potential consequences and motivators. 

The second is the National Archives and Records Administration framework for risk assessment. This helps to assess current file formats, the long-term risk of them becoming obsolete and what formats you should convert them to if you need to preserve them. 

Until next time!