Summary
Recent years have seen a shift by regulators around the world to place more focus on the retention of data and records.
The need for appropriate strategies for data retention will only increase
EU CTR requiring sponsors to retain essential records such as the trial master file for a minimum of 25 years stands a benchmark for any sponsor looking to sell a drug into the European market. The new UK Clinical Trial is following suit and while the ICH have not recommended a minimum retention period in the latest revision to E6, there is more focus on the provision for essential records retention (beyond just documents).
As the industry starts to fully transition away from paper towards a fully digital future, the need for appropriate strategies for data retention will only increase. Central to this is maintaining data integrity through alignment to the ALCOA+ principles, throughout the entire data lifecycle, which also includes the retention period.
Whatever system you use for the retention of the eTMF and essential records, please consider the below:
- Data Integrity MUST be maintained throughout the retention period, which as we've stated can be for 25 years or more, for the eTMF and essential clinical records. During this time, data MUST remain readable, usable and readily accessible according to the ALCOA+ principles.
- Data MUST be inspection ready with immediate and user-friendly access. Inspectors MUST be able to see (i.e. evidenced) that Data Integrity has been maintained, that no data has been corrupted, lost or altered, and be able to confirm the conduct of the original clinical trial.
- Systems used to retain data MUST be demonstrably fit for their intended purpose. Systems for retention, archiving and preservation MUST have been designed, built, tested and most importantly validated as being fit for the purpose of maintain long-term Data Integrity according to all the ALCOA+ principles.
I hope that this guide has provided a useful starting point for sponsors and other stakeholders seeking to improve their approach to data retention.
If you would like to speak to the Arkivum team about anything covered in this guide, please either email us hello@arkivum.com or contact via our website here.
The recent updates to ICH E6 (R3) have expanded the guidance beyond documents to all essential records and data
eBook: Guide to selecting an external archiving supplier
If you’re interested in finding out more about how to start the process of selecting an partner to support you with your data retention requirements, we recently published the eBook: A Guide to Assessing Third-Party Archiving Solutions.
Access the guide below.
About the eBook
Choosing a third-party archiving solution can be a difficult process as there are many factors and influences involved. Each organisation is different, with different requirements, different sizes of teams, and different levels of internal expertise and knowledge. This can mean that multiple stakeholders are to be considered in the process of selection to ensure they have access. What’s more, in the pharmaceutical industry, data integrity, security, and compliance are paramount. Therefore, making informed decisions about a digital archiving vendor is crucial.
The overarching objective of this guide is to provide a structured framework that allows organisations to evaluate potential third-party archiving solutions based on their specific requirements.
In utilising this guide, organisations can ensure they select a solution that aligns with their unique needs while mitigating risks and maximising the long-term preservation of their valuable data.