Live Clinical Trial Systems and Long-Term Data Preservation: Why CRFs Need Both

In an industry where regulatory scrutiny and data integrity are paramount, how we manage clinical trial data during and after the trial is crucial. Case Report Forms (CRFs), essential for capturing participant data in real time, serve as the foundation of trial documentation. But what becomes of this critical data once the study concludes? This blog explores the key difference between live trial systems and long-term preservation platforms, explaining why both are essential and how they complement each other in safeguarding your clinical data.

What Are CRFs and Why Are They Crucial?

Case Report Forms (CRFs) are standardised documents used to collect data from participants during a clinical trial. They serve as the primary tool for capturing clinical observations, protocol-specified information, and safety data in a consistent and structured way. CRFs are crucial because they ensure that data is recorded accurately, uniformly, and in compliance with regulatory requirements. They also play a key role in validating the outcomes of a study and supporting regulatory submissions. Without well-designed and well-managed CRFs, the integrity of a clinical trial and its ability to demonstrate efficacy and safety can be compromised.

Live Systems: Managing Data While the Clinical Trial Is Active

Live clinical trial systems serve as the operational heart during a study. They offer:

• Real-time data capture and validation: Ensuring data integrity at the point of entry.
• Query management: Quickly addressing discrepancies or missing data.
• User access controls and audit trails: For transparency and accountability.

These systems are designed for agility and interaction, helping clinical teams stay on top of trial progress and quality. However, they are primarily built for the active phase of a study.

The Challenge After the Trial

According to ICH E6(R3) Good Clinical Practice Guideline, Case Report Forms (CRFs) are considered essential records in clinical research. This includes not only CRFs themselves but also associated materials such as diaries and clinical outcome assessments, including patient-reported outcomes, that are provided to the investigator and/or IRB/IEC. These documents are critical for verifying the integrity of the trial and ensuring regulatory compliance, making their accurate capture and long-term preservation of the utmost importance.

Once the clinical trial concludes, the data’s role doesn’t end. Regulatory agencies like the FDA, MHRA, and EMA require trial data, including eCRFs, audit trails, and related documents to be retained securely for 15 to 25 years or more (EU CTR No 536/2014, Art. 58(3), MHRA GCP Guide, 2022). This extended retention period ensures that the data remains accessible for audits, inspections, marketing applications, and post-marketing commitments. Failing to retain essential records like CRFs can compromise regulatory submissions and trial integrity.

This extended retention is critical for:

• Regulatory inspections and audits
• Supporting product lifecycle management
• Pharmacovigilance and safety monitoring
• Legal and scientific review

Why Not Keep all Clinical Data in the Live System?

While live systems excel during clinical trials, they are not designed for long-term clinical data preservation. Reasons include:

• System upgrades or decommissioning: Over time, platforms change or are replaced.
• Data format obsolescence: Legacy software may no longer read old data formats.
• Risk of data loss or corruption: Without appropriate safeguarding features, data integrity can be compromised, which is even more significant when retaining data for long periods of time.
• Data consolidation: CRFs should not be stored in a live system to ensure data consolidation, preventing data sprawl and maintaining a single, secure source of truth for accurate and reliable trial records.
• Cost and efficiency: Maintaining live systems for decades isn’t practical or cost-effective.

Long-Term Preservation Platforms

Some live clinical systems offer basic archiving capabilities, but they’re primarily designed for active data management, not for preserving data over decades. That’s where long-term digital preservation platforms make a critical difference. Unlike live systems, which may lack the purpose and capability required for compliance with long-term retention regulations, preservation platforms are purpose-built for longevity. They provide features like immutable storage, automated preservation copies, and comprehensive audit trails, ensuring data remains accessible, unaltered, and inspection-ready well into the future. Transferring data from live systems into a dedicated preservation environment protects clinical records from technological obsolescence, reduces risk, and meets the high standards regulators expect long after a trial ends.

A Complementary Approach to Clinical Data Management

In summary:

Both systems play distinct but complementary roles in the clinical data lifecycle. This approach minimises risks, optimises cost, and ensures regulatory readiness, protecting the integrity of your clinical trial data for years to come.

CRFs, Live Systems, and Long-Term Preservation Conclusion

As clinical trials grow more complex and regulatory expectations continue to evolve, the need for a dual-system approach has never been more evident. Live clinical systems are indispensable for managing data during the active phases of a trial but they are not built for the decades-long preservation that regulators and sponsors demand. By pairing these systems with dedicated long-term preservation platforms, organisations can ensure their Case Report Forms and associated data remain accurate, accessible, and audit-ready far beyond the trial’s close. In short, successful clinical data management doesn’t end when the trial does, and your preservation strategy shouldn’t either.