Management of eTMF health is vital throughout the lifecycle of the clinical trial. Like how a yearly MOT is performed on a vehicle to determine its ‘roadworthiness’ and ‘safety’, the main premise of these tests run parallel to that of a clinical trial.
For anyone unaware of what an MOT test is, it is a UK mandatory examination that all vehicles must undergo to be lawfully driven on the road. This test consists of many different checks to the vehicle to confirm its alignment to UK road standards.
So, as you would with your vehicle, you should also subject your eTMF to an “MOT” undergoing multiple checks and tests throughout the study. The objective here is to ensure the timeliness, completeness and quality of the eTMF; all essential metrics in eTMF management. Regularly “MOTing” your eTMF is also useful for inspections as you’ll maintain the preparation of the documentation and systems involved.
Furthermore, after a successful trial seeing the launch of a new drug, various regulations across the world require clinical trial data to be stored in its original form with ease of access for the long-term. Ensuring that the eTMF is consistently ‘health’ checked can assist in regulatory compliance, as well as assisting in a smooth transfer of data into an archive after the clinical trial.
As a long-term preservation and archiving solution provider, we’ve seen many issues during the data migration phase (transferring the eTMF into the archive). One example being, during our metadata checks, there have been occasions of discovering missing documents or datasets. This resulted in presenting these issues to the CRO, which further delayed the archival process. Therefore, its best to avoid these issues early to ensure a smooth transition.
Although I’m making these comparisons from an eTMF review to a vehicle MOT, one difference (amongst many obvious differences) is that unlike an MOT test taking on average 45 minutes to complete, this eTMF ‘check-up’ needs to be consistently implemented throughout the trial. As much as I would love to tell you it’s a one-off check-up, it is not. But the rewards of a smoothly conducted trial is a much more significant success than your car somehow passing its MOT despite being convinced it wouldn’t.
I would also like to note that I am not suggesting that there is a “one size fits all” approach to reviewing your eTMF. In saying this, it’s important to review the points made in this article and adjust accordingly to your organisation (whether this may be the metrics used or the process).
Anyway, let’s drive right into our eTMF garage.
Conducting an “MOT” on the eTMF
First and foremost, it’s necessary to define key metrics to help measure against throughout the ‘MOT’. As mentioned earlier, some key metrics in eTMF management include regulatory and ethics compliance, timeliness, completeness and quality. Measuring up against these metrics will ensure an overall ‘healthy’ eTMF through identifying areas for improvement.
Audit Your eTMF
Similar to a parts check, eTMF auditing ensures that all documents are properly indexed, labelled and stored to identify and correct any errors or inconsistencies. This can help identify the completeness of the eTMF (one of the essential metrics mentioned earlier) which helps align it with eTMF procedures and compliance. I would suggest using a risk-based approach in auditing your eTMF documents. See our blog on what a risk-based approach is and what it entails.
Regularly check the metadata to ensure it is complete and accurate. Checking the metadata is particularly important if you are using software that automatically attributes metadata to documentation. Turning a blind eye to automatic metadata generation can cause inaccuracies or gaps amongst your eTMF which may cause issues when the study needs to be archived.
Disaster Recovery Plan
Another area for regular testing is your eTMF’s disaster recovery plan. This is to ensure that you can quickly and effectively restore access to your study data in the event of an emergency. Having a poor disaster recovery plan or no plan at all can put your data at risk of complete loss if something detrimental were to happen.
Train Your Team
Knowledge is power right? Only if they are completely up to date on the latest systems in terms of navigating, uploading and accessing documents as well as troubleshooting common issues. Don’t let human error lead to catastrophic problems, train your team appropriately in accordance with GxP, the organisational structure and standard operating procedures (SOPs).
Remaining compliant within your eTMF can be the make or break of your clinical trial. Failure to remain compliant can lead to repercussions. Reputational damage, legal action, fines, delays etc. Conducting a gap analysis is crucial in ensuring compliance. It involves comparing your eTMF against the current regulatory guidelines and industry standards to identify any missing or outdated document. This will help you identify areas where your eTMF may need improvement. Check out our blog on ‘how to become inspection ready’ for more information.
Review User Access and History of the Documents
It’s always good to know the history of your eTMF. Audit trails can determine who has accessed your documents, what changes have been made and when, etc. Not only is this important for compliance, but reviewing user access can help prevent untrained and unauthorised people from accessing your documents or restricting unapproved changes from being made- this will help protect the integrity of your study data.
Review and Update SOPs
Over time, things change. Did you know that before 1977, brake lights weren’t checked in an MOT? Or that checking the functionality of rear seatbelts wasn’t introduced until 1991? eTMF regulations also change, so it is important that you continuously review and update your eTMF SOPs, so they are current with regulatory guidelines. This will also assist in maintaining correct usage of the eTMF by your team.
Conducting these check-ups regularly can ensure that your eTMF is functioning optimally and in compliance with regulatory guidelines. This can also help you identify potential issues early enough to take pro-active action rather than waiting to take re-active action. Whether this may be avoiding issues prior to inspections or for after the clinical trial has concluded, and the eTMF is being transferred to a long-term archive.
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