Navigating Audit Trail Data Regulations And Accessibility Changes

By James Stringer

Data is the cornerstone of clinical trials, underpinning critical decisions about therapies and trial performance. It highlights recruitment speed and drug supply management and is subject to rigorous regulatory scrutiny. The versatile nature of data means its utility varies based on the user's needs.

In a highly regulated industry, new guidelines continually emerge while existing ones gain prominence as the sector evolves. Regulatory bodies like the UK's MHRA, the EU's EMA, and the US's FDA mandate documented, human-readable, and regularly reviewed audit trails.

The EMA's March 2023 guidance emphasizes the investigator’s responsibility for audit trail reviews and data ownership, acknowledging the complexity this poses for data providers. Despite the longstanding nature of these regulations, a complete industry-wide solution remains elusive.

This raises the question: How can proprietary audit trail data, stored in proprietary formats, be effectively accessed and utilized?