Introduction
The transfer of the eTMF at the end of a trial is a critical step in the lifecycle of that data.
Successfully moving these records from CRO to Sponsor is crucial to the management of the trial, but it also creates several risks, challenges and opportunities.
In this guide we will provide some simple steps to help Sponsors plan for a smooth and successful transfer at the conclusion of a trial.
And more importantly, the steps contained within this guide will ensure the long-term integrity, use and compliance of these records long into the future.
Why is the transfer of clinical data such a crucial step?
- Data integrity can be compromised in transit
- It’s often moved into a solution that isn’t appropriate or complies with regulations
- The transfer hasn’t been planned out
- People are unsure of where the data’s responsibility lies
- Transferred using inappropriate media
At the end of a trial, the data is transferred from the CRO back to the Sponsor. It’s the sponsor’s responsibility to archive it so that it complies with regulations.
What Sponsors need to know.
Once you’ve received your data, how will you ensure its integrity remains intact?
Firstly, you must have a plan for transferring and accepting your data. Discuss internally with your teams to establish how you will be retaining that data.
Review relevant regulations. 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.
Secondly, to prevent deterioration and file format obsolescence (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.
A digital archiving and preservation solution can provide you with:
- Eliminated risk of records deterioration and file format obsolescence.
- Secure access to the data from anywhere in the world.
- Providing and retaining discoverability via metadata applied during the study.