Should you be digitising historic TMF and GCP records for archival?

Have you ever had to sift through thousands of archived paper records to find a document required by an inspector? Or are you worried around the ongoing and growing costs of paper archival?    

Not only may your concerns lie in these factors, but also around the impact on environmental sustainability in continuing to retain paper records. What’s more, does all the archived physical documentation present significant untapped value that is not utilised due to difficulties around accessing? 

All these concerns and considerations can be relieved by digitising your physical records for archival. Not only does this allow for better accessibility and efficiency, but it also frees up valuable space for other high priority business activities. 

Digitising records for archival can be a game-changer for your post-clinical trial data management. Here’s why.  

Ease of access 

Let’s cut to the chase here, files within digital archives are generally easier to access. This is due to multiple reasons, such as: 

• The entire archive is accessed online, there is no requesting documents to be sent to you. 

• Online archives are searched via queries. When you need a specific file, at minimum you’ll need to type up relevant keywords similar to the metadata and the resulting file should appear.  
• Documents are available for immediate viewing. Some solutions (such as Arkivum) offer a file viewer, meaning that documents can be viewed within the solution as opposed to having to download the document to open it.  

Paper-based archives on the other hand, are tricky in terms of its accessibility. Physical archives are often managed by a third-party storage company. If you need a specific file,  the archive will need to be searched before finding and sending the file to your location. This can take weeks upon the initial request.   

To put this into context, say your clinical trial, that has their documents filed in a physical archive, is called for inspection. Regulation states that: 

The content of the clinical trial master file shall be archived in a way that ensures that it is readily available and accessible, upon request, to the competent authorities. – EU Regulation 536/2014, Article 58 Clinical trial master file 

The documents that the inspector requires must be presented in a timely manner. There are different routes you can go here, either locate and make a digital copy of the documents and send to the necessary official or locate, copy and physically send the documents via transit. Both these options are significantly more complex in the grand scheme of things and take more time and resource than a full digital archive. In a digital archive, files can be presented in a matter of minutes are searching for metadata or following the structure presented in one system. 

A Portable TMF

With a digital archive, not only can documents be accessed in a matter of minutes, but the data it holds is portable. For example, if an organisation were to acquire a drug from the original sponsor, the data that sits within a digital archive would need to be transported to the purchaser. Again, for a physical archive, this would take weeks. However, files in a digital archive can be processed and transferred in a matter of days at most.  

Additional value from accessible records

In addition to the above points, we cannot forget about the accessibility to valuable information. There is a wealth of information which has often been underutilised as it sits within a physical archive.  

This data could be accessed a range of reasons including: 

• Informing future trial design 
• Repurposing approved drugs 
• New formulations 

With an ever-growing digital archive, and the inclusion of historic records, it is also possible to start to think about running broader analytics across datasets, for example improving efficiencies in trial management. Without access to this data, that task is extremely challenging. 

When deciding on the use of digital or physical record keeping, think about the potential for future use of the data. Digital records, as we’ve already established, are easier to access and search through, meaning that this issue is nowhere near to the same extent.  

Audit Trails 

EU Regulation requires any, and all, changes made to TMF documentation to be recorded and readily available. This includes capturing who has accessed the archive, when they accessed it, and what they did; this can’t be monitored as closely with a physical archive.  

Any alteration to the content of the clinical trial master file shall be traceable. – EU Regulation 536/2014, Article 58 Clinical trial master file 

Again, I’m going to look at this from a convenience angle. It is not impossible to generate an accurate audit trail of access and alterations in a physical archive, but it is far more inconvenient. Digital archives, particularly ones with audit trail capabilities, automatically produce audit trails and recorded alterations. For physical archives, this is a manual process of reporting access and alterations.  

The inconvenience of this task has a direct impact on the resource cost, which leads us into our next point.    

Timeliness and Cost 

Overall, the additional processes in using a physical archive all cost a precious resource in clinical trials, that is, time. 

The process of managing and preparing documents for a physical archive becomes complex and requires more time to organise and sort. In the long-term, the process of preserving these documents also becomes manual. If there comes a time whereby the documents need to be transferred to another facility, this requires personnel, fleet and time to fulfil this task. 

Transferring data to a dedicated digital archive and preservation repository removes the lengthy manual process requirements of data retention management. Digital preservation as a process is less timely, protecting data for the long-term without lengthy manual processes and high fees attributed to storing in a physical archive.   

Let’s also not forget about metadata, a critical aspect of all records. Applying metadata to physical documents takes time and mistakes are often made. Whereas many digital software create metadata when the documents are generated. Moreover, the systems identify missing information in metadata, meaning less mistakes are made on this matter. 

Environmental Sustainability 

Similar to our previous point, there should be consideration of the cost to the environment. It can be difficult to fully decipher ongoing environmental impact of physical archiving, particularly where documentation sits within an external facility. Digital archives, on the other hand, can be much more easily tracked and measured in terms of its long-term environmental impact. Furthermore, it is easier to manage the carbon footprint of a digital archive. For instance, with digital archives, database servers can be controlled remotely, meaning that they can be switched off instead of constantly running idle.  

In summary…  

In essence, the long-term benefits present itself in the form of ease of access, efficient management and cost effectiveness in terms of timeliness and money – all of which present a strong case to undertake a digitisation project of your historical paper records.  

Once digitised, we would strongly recommend investing in a dedicated digital archive solution. This would ensure that your data is safe, secure and compliant to long-term retention regulations. Here at Arkivum, we take out the stress of remaining compliant to retention requirements and maintaining data integrity with our leading digital archiving and preservation solution.  

Check out our recent demo to see how our solution can meet your organisation’s needs. https://arkivum.com/webinar-protecting-data-for-long-term-use-an-insight-into-arkivums-digital-archiving-and-preservation-solution/