ICH E6(R3) Raises the Bar for Data Governance — And Biospecimen Management is No Exception
For years, biospecimen management in clinical trials has operated in a gray area when it comes to data governance. While data integrity has always been a pillar of Good Clinical Practice (GCP), the specifics around how sponsors should govern sample metadata — especially when managed through digital systems — haven’t always been clear. But that’s changing.
With the arrival of ICH E6(R3), the International Council for Harmonisation has made one thing very clear: biospecimens are now part of the essential trial record, and therefore squarely within the scope of modern data governance requirements. The latest revision doesn’t just reinforce the importance of reliable, high-quality data. It introduces detailed mandates for how computerized systems must be validated, documented, and secured across the entire clinical trial lifecycle.
And for sponsors, that raises the stakes considerably.
Data governance: No longer optional for biospecimens
ICH E6(R3) introduces a new, comprehensive section on data governance — signaling a major shift in how regulatory bodies view data-related risk. Now, sponsors are expected to apply rigorous data governance practices to all computerized systems that handle clinical trial data, including those used for sample tracking and sample metadata management. This includes sample tracking spreadsheets, as well as any software tool used for capturing, managing, or sharing sample metadata.
Here’s what the new guidance actually says:
“Documented procedures should be in place to ensure the appropriate use of computerized systems in clinical trials for essential activities related to data collection, handling and management.” — ICH E6(R3) Section 4.3.1
In other words, if your biospecimen operations rely on a digital system — and most do if you’re using Excel-based sample trackers — it needs to meet a higher bar for governance, security, and traceability.
Curious how the updated guidelines impact you if you’re using paper for key processes like requisition forms? Click here to sign up for our live webinar, “The Impact of ICH E6(R3) on Biospecimen Management”.
What’s at risk? More than just compliance
If data pertaining to your samples isn’t governed properly, it can lead to serious consequences:
- Missing or inaccurate sample metadata that compromises or delays lab analyses or results reporting
- Breakdowns in sample chain of custody, which can threaten study integrity
- Inability to retrieve or verify historical data during audits or inspections
- Noncompliance penalties from regulators or trial delays due to remediation efforts
And let’s not forget the broader impact: downstream decisions in translational medicine and biomarker discovery rely on clean, trusted biospecimen data. Without it, the science suffers.
ICH E6(R3) is essentially raising a red flag here: if your data governance practices for biospecimens haven’t kept up with the digital tools you’re using, your trial is at risk — from both a regulatory and scientific standpoint.
Why spreadsheets and siloed systems no longer cut it
Sponsors have long relied on spreadsheets or fragmented systems to track samples. But ICH E6(R3) makes it clear: those days are over.
“The [sponsor] should ensure that the computerized systems are validated as fit for purpose… [and that] validation documentation is maintained and retained.” — ICH E6(R3) Section 4.3.4(g)
If your current system can’t produce a full audit trail, doesn’t have documented validation processes, or lacks user access controls — it may no longer be defensible during an audit. This may even implicate your lab-specific e-requisition solutions.
What does good look like?
Sponsors now need to ensure their biospecimen systems meet core data governance principles, including:
- Validation: Systems must be proven fit-for-purpose and properly documented
- Traceability: Every sample’s lifecycle — from collection to analysis — must be auditable
- Access Control: Only authorized users should be able to view or edit sample data
- Retention: Metadata must remain intact, readable, and retrievable throughout its retention period
- Accuracy and Integrity: Systems must minimize the risk of human error and data loss
These requirements aren’t just regulatory formalities. They’re essential for maintaining trust in the data that drives decision-making in clinical research.
Want to learn more? Join our live webinar
If you’re wondering how to assess your current systems, what regulators will be looking for, or how to future-proof your biospecimen operations under ICH E6(R3), we’ve got you covered.
Join us for a live webinar: “The Impact of ICH E6(R3) on Biospecimen Management” on April 15th at 11am EST.
Featuring:
- Edye Edens, Life Sciences Legal and Regulatory Expert, Kulkarni Law Firm
- Rust Felix, CEO, Slope
- Aman Khera, Regulatory Science and Innovation Advisor, President of TOPRA
You’ll learn:
- What ICH E6(R3) says about biospecimen operations
- How to align your biospecimen management practices with the new requirements
- What steps to take now to ensure compliance ahead of the EMA’s July implementation deadline
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