So, your study is complete. All the documents have been recorded and collected. Completeness is at 100%. You‘re ready to move on to the next study.
But wait, before you can do anything, you first need to receive your TMF from the Contract Research Organisation (CRO)…
This is one of the final steps for your study in its ‘live’ state.
Your CRO has been creating and collating content since the study started and have likely (hopefully) been storing this within an eTMF.
As a result, these records have so far been secured in a validated system which has also provided you with comprehensive audit trails and instant access (when required).
Now they are going to export that data and hand it over to you… but in what format? A DVD, a USB stick, access to a shared folder for you to copy the folder and paste onto your laptop?
Maintaining TMF Data Integrity
So, what happens next?
Without an appropriate plan in place, all the work done preserving the integrity of that TMF, the unique ways of navigating your content and the security, backup and redundancy will be lost.
Accepting that data is one of the most critical things for any sponsor as it is accepting ownership of the TMF and hosting all that information, the same information that regulators will want to review when performing their inspections. Getting it right is crucial.
Planning your TMF Migration
There are three simple initial steps to help create a plan for your TMF migration:
- Make sure that you have a plan for accepting the TMF before the study ends.
- Discuss internally with your teams to establish how you will be retaining that data.
- Review the regulations such as Regulation EU No 536/2014 and the EMA Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic).
Focus must be placed on ensuring your data is readily available and directly accessible, any changes should be traceable, and this should be maintained for the duration of the archived period, potentially upwards of 25 years.
Creating a purpose-built solution
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.
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.
By doing so, you’ll benefit from:
- 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.
For further information on any of these points or to review the regulations and what they mean for you, please get in touch with us.
Alternatively, please read the next blog in this 3-part series.
01 Feb, 2022
What to plan for when transferring your TMF?
29 Mar, 2021
Should you build or buy your eTMF archival solution?
24 Sep, 2021