Maintaining Data Integrity
Not to repeat what we’ve previously mentioned but maintaining the integrity of clinical data and the TMF is crucial.
Integrity must be maintained for the duration of a trial, as well as at the point of transfer - and once it’s been received.
It’s fair to say that without an appropriate migration plan or digital archive in place, the work done preserving the integrity of your TMF, the unique ways of navigating your content and the security, backup and redundancy will be lost.
How can you ensure integrity remains?
First and foremost, you must have a plan for the actions that will be carried out to prepare and transfer the data.
Not only is it simply good practice to have these elements factored in long before the end of a trial approaches but by appropriately retaining data integrity is a core principle of the ALCOA principles.
Keen to learn more about the ALCOA principles?
PLUS...many of the ALCOA+ principles utilised in GxP guidelines and they are often referenced alongside the FDA’s 21 CFR Part 11 and the EMA’s eTMF regulations.
Does your storage solution protect data integrity?
Methods such as DVD, tape, network storage or even cloud sharing platforms like Dropbox may have their appeal and benefits at the beginning (they’re readily available, relatively cheap and a quick fix), but these won’t last…and they’re not complaint with the previously mentioned regulations.
First and foremost, they simply do not provide the benefits of a digital archiving and preservation solution. As a result, deterioration and file format obsolescence are real risks.
Appropriate (and industry standard) methods of content navigation is non-existent in solutions which haven’t been purpose-built for clinical data and audit trails are not recorded which are a regulatory requirement from several official bodies.
To prevent these circumstances (and more) from happening, you should look to bring in a purpose-built long-term data management solution that provides preservation across the entire study.
Additionally, retaining your data within our digital archive will benefit you with:
- Eliminated risk of records deterioration and file format obsolesce.
- Secure access to the data from anywhere in the world.
- Providing and retaining discoverability via metadata applied during the study.
- A validated system which is a must when working in this regulated environment.