The Importance of Maintaining Chain of Custody and Audit Trails

Urine Sample

In February 2022, former Milwaukee Brewers outfielder Ryan Braun made baseball history by becoming the first major-league player to have a positive drug test overturned on appeal.

How? It came down to the samples’ chain of custody.

The National League’s most valuable player dodged a 50-game suspension when it was shown that his urine sample had not been handled in accordance with Major League Baseball’s chain-of-custody policy for drug testing. The policy required specimens to be sent to the laboratory on the same day they are collected or to be appropriately safeguarded in a cool and secure location if not immediately prepared for shipment. Instead, the collector kept the sample in a home refrigerator for two days, leading a three-person arbitration panel to rule that a lapse in protocol had been committed.

While Braun was suspended the following year and eventually admitted to using performance-enhancing drugs, the dispute clearly underscores the hazards of any failure to comply with laboratory regulations.

As cutting-edge technology intertwines with meticulous research protocols and manufacturing quality control (QC) testing, the significance of maintaining data integrity and traceability has never been more crucial. Laboratories rely on two essential

Data Integrity

Laboratory Information Management Systems (LIMS) components to achieve this: chain of custody (CoC) and audit trails.

Understanding their respective nuances and applications empowers labs to make better-informed decisions and uphold the highest data accuracy and accountability standards. Let’s take a closer look at each one in turn.

Chain of Custody (CoC)

An indispensable concept in scientific research, good manufacturing practices (GMP) and legal contexts, the core function of a chain of custody record is to ensure that a sample is never out of an accountable party’s direct supervision and control. It refers to the chronological and documented trail of the custody, control, and transfer of samples, materials, and data from their source to their ultimate destination.

Chain of Custody ensures the integrity of the data is preserved by preventing any unauthorized access, tampering, or contamination. This becomes particularly critical when dealing with sensitive or regulated data, such as in forensic investigations, clinical trials, or environmental studies.

CoC Applications

  • Forensics: In criminal investigations, maintaining an unbroken CoC is essential to ensure that evidence is admissible in court. If it can be demonstrated that the evidence presented is not as it was collected from the crime scene, or that it has been tampered with in any way, it can be ruled inadmissible – potentially destroying any case.
  • Pharmaceutical and Clinical Research: CoC is also vital in drug development and clinical trials, where data integrity and traceability are essential for regulatory compliance and patient safety. For example, during the development of the Human Papillomavirus (HPV) vaccine, clinical trial data had to be meticulously collected, preserved and transferred following CoC protocols. This ensured the data’s credibility and helped gain regulatory approval, leading to a vaccine that has since significantly reduced HPV-related diseases.
  • Environmental Monitoring: CoC helps track samples and data in environmental studies, ensuring accurate assessments and compliance with environmental regulations. For example, in the Deepwater Horizon oil spill disaster, the CoC ensured that collected samples from affected areas were uncontaminated, securely stored, and reliably analyzed. This allowed authorities to assess the extent of environmental damage and hold responsible parties accountable.

Audit Trails

An audit trail is a detailed, time-stamped record that tracks every action, change, or event that occurs within the LIMS. It serves as a transparent history of data modifications, providing an invaluable tool for identifying and addressing any discrepancies, errors, or potential issues that may arise during data handling and analysis.

The audit trail guarantees accountability by aiding in the investigation of data-related incidents and ensuring compliance with quality standards and regulatory requirements.

Audit Trail Applications

  • Data Quality Assurance: Audit trails act as a safeguard against accidental or malicious alterations, enabling the identification of erroneous inputs and enhancing data accuracy.
  • Regulatory Compliance: In highly regulated industries, such as pharmaceuticals and food testing, audit trails offer auditors an unambiguous view of data history, ensuring adherence to industry guidelines and governmental regulations.
  • Process Improvement: Analyzing audit trails can help laboratories identify bottlenecks, optimize workflows, and enhance overall data management practices.

Understanding the Difference between Chain of Custody and Audits Trails

In the digital landscape of modern laboratories, understanding the vital distinctions between chain of custody and audit trails is pivotal for ensuring data reliability, security, and compliance. The chain of custody safeguards the journey of samples and data, securing their integrity from inception to conclusion, while audit trails provide a comprehensive and transparent account of every data-related activity, bolstering accountability and facilitating continuous improvement.

By harnessing the power of these tools within LIMS, laboratories can elevate their data management practices, foster groundbreaking research, and uphold the highest standards of scientific excellence.

To learn how LabVantage provides fully integrated CoC and audit trail functionality for the forensics, pharma R&D, food & beverage, and environmental monitoring fields, contact us today.