Sponsors, Your Oversight Responsibilities Have Changed: The New Compliance Risks in Biospecimen Management

The landscape of clinical trial regulation is shifting — and sponsors can no longer afford to think of oversight as a shared responsibility spread evenly across stakeholders. With the updated ICH E6(R3) guidance, the onus is clearer than ever: sponsors are explicitly accountable for oversight of all systems, vendors, and processes that impact trial quality, data integrity, and participant safety. That includes biospecimen management.

While oversight has always been a pillar of Good Clinical Practice (GCP), ICH E6(R3) sharpens the focus. It removes ambiguity around who is ultimately responsible and draws a direct line from oversight to quality outcomes — particularly in areas where risk has historically gone under-assessed, like biospecimen handling, tracking, and data management.

So what does that mean for you as a sponsor? It means your biospecimen operations can no longer fly under the radar. You must have systems, documentation, and controls in place to ensure that every vial, every process, every vendor, and every data point related to biospecimens is fully traceable, validated, and managed according to the protocol.

Let’s dig into what’s changed — and what you can do about it.

What ICH E6(R3) says about sponsor oversight

ICH E6(R3) introduces firmer expectations around how sponsors ensure quality across the lifecycle of a clinical trial. Two clauses are especially relevant to biospecimen management:

• Section 3.10:
  “The sponsor should implement an appropriate system to manage quality throughout all stages of the trial process.”
  This includes tools and procedures for trial conduct, particularly those used for data collection and management — a category in which sample metadata squarely fits.
  
  
• Section 3.16.1 (d & e):
  “The sponsor should ensure that data acquisition tools are fit for purpose and designed to capture the information required by the protocol. They should be validated and ready for use prior to their required use in the trial.”

The takeaway? If your biospecimen processes — or the tools and vendors supporting them — are not fit for purpose, validated, or fully documented, you’re at risk of non-compliance.

Want to understand your risk profile for non-compliance with ICH E6(R3)? Take our free 3-minute self-assessment now.

Why this matters for biospecimen management

Historically, biospecimen management has existed in a grey area between different stakeholders. But with ICH E6(R3), that grey area is disappearing.

The new guidance explicitly calls for:

• Clearly defined and documented roles and responsibilities across all trial activities, including those related to biospecimens.
• Validated systems and tools to ensure integrity and traceability of all clinical data — including biospecimens.
• Oversight of third-party vendors who handle biospecimens, with the sponsor responsible for proper selection, qualification, and ongoing quality monitoring.

In other words, it’s not enough to assume your labs, sites, or other vendors “have it handled.” If samples go missing, if metadata and audit trails aren’t properly recorded, or if a vendor process isn’t validated — regulators will look to the sponsor.

What's at stake?

Non-compliance with ICH E6(R3) isn’t just a regulatory risk. It can compromise your science and undermine trust in your data. Without robust biospecimen oversight, you risk:

• Protocol deviations caused by missing or mishandled samples
• Trial delays due to rework or lost sample integrity
• Regulatory findings during inspection
• Erosion of data quality and scientific credibility

And yet, many sponsors still rely on spreadsheets, email threads, or fragmented lab systems to manage sample logistics and metadata. That kind of setup may no longer cut it.

How at-risk are you?

To help sponsors understand their risk profile, we created a 3-minute self-assessment. It’s designed specifically for sponsors to evaluate their preparedness for ICH E6(R3) across their biospecimen operations — specifically in the areas of oversight, risk-based quality management, and data governance.

By answering a few quick questions, you'll get a high-level scorecard showing the degree of your risk for non-compliance.

👉 Take the ICH E6(R3) Risk Self-Assessment

Don’t wait for an inspection to find out your processes aren’t compliant. Get clarity now — and take the first step toward confident, compliant biospecimen oversight.