eTMF Archiving Myths Busted

We hear time and time again – “oh, we thought…’ or, “we were told…”

We thought it was time to put a stop to some of the misconceptions and misinformation we hear most when it comes to eTMF archiving and preservation. We’ve delved into our top 3 below.

Misconception no. 1: ‘Archiving data in your eTMF system will meet regulatory standards’

First and foremost, eTMF systems are designed for collecting data, measuring and maintaining real-time timeliness, quality and completeness and providing a single source of truth for the conduct of the trial.

Yet whilst they’re fantastic solutions for running a clinical trial – and although they may appear to have all the features required for long term retention – they fall short across a number of areas.

Benefits:

• Often already a Validated solution.
• Solution is already established and embedded in the organisation.
• Secure access controls.
• Benefits of in-system metrics and analysis.

Dangers:

• Files are stored in their original native format they were provided so there is no long-term file format conversion.
• No integrity checks on data.
• Data is retained in a live state for the duration of its storage – this can become extremely costly for a sponsor.
• Archived data is not really archived, just “locked” in a “read only” state.
• Ownership stays within the system and system owner, not the archivist.

Misconception no. 2: ‘Can I store my data I store using a file sharing site like Dropbox, Sharepoint or OneDrive?’

The primary function of these solutions are designed to aid collaboration and act as a repository for content authoring, review, approval, collaboration, and day-to-day management of active.

Benefits:

• Relatively cheap.
• Often already in the business so no start up time or requirement for buy in.
• Provides online access to files.

Dangers:

• Files are stored in their original native format they were provided so there is no long-term file format conversion.
• Integrity checks are difficult and involve long, and often manual processes and so not often performed.
•  Single copies are stored unless manually duplicated.
• Solution is not validated.
•  No audit trails are captured of who has accessed or changed files (and not time-stamped either).
•  Limited and fixed metadata make search and discovery difficult and/or lengthy.

Misconception no. 3: ‘CROs should be responsible for the archival of the eTMF, not sponsors’

CROs play a major part in the running of a clinical trial and provide Sponsors with a huge array of services and support. Interestingly, it’s often assumed that CROs may be better equipped to handle the archival of the eTMF as opposed to sponsors but the truth is, they have the same limitations as the above.

When you consider that CROs are unlikely to be using eTMF solutions, increased risk can occur in regard to accessibility, ownership and the inability to have a central location for all data; Sponsors often use multiple CROs which would result in multiple Archives. Ultimately, maintaining the data correctly is the Sponsor’s responsibility and outsourcing that can cause issues.

In closing…

Hopefully we’ve answered some queries you may have had. The content from this article is just one area of our newly revised and published guide to eTMF and clinical data archiving and preservation.

There’s a lot of information  publicly available relating to the long-term management of clinical data and it can be easy to get confused. Here at Arkivum, we aim to  cut through the confusion and provide you with the information you need in order to choose the right data management strategy for your organisation.

If you’d like to read more of our content, you can sign up to our newsletter and be notified or perhaps you have other myths you’d like some clarity on? You can contact our team here land we can help your data management efforts.

 We’ve recently updated and revised our eTMF eBook which you may find helpful. From highlighting where and how effective digital archiving and preservation aids the long-term management of the eTMF, maintaining data integrity, migrating your data and much more!