Meeting expectations with human-readable audit trail

Meeting expectations with human-readable audit trail

A regulatory requirement

Audit trails are a cornerstone of compliance in clinical trials, ensuring transparency and data integrity throughout the research process. However, despite being a regulatory requirement outlined by authorities such as the FDA and EMA, the execution of audit trails in clinical trial technology has historically been a source of frustration for trial teams and clinical sites. Many eClinical systems generate audit trails that are either not readily accessible or not easily interpretable, creating significant pressure during regulatory inspections.

Interpreting the regulations

One of the most significant challenges in creating audit trails is determining what data points should be included. While regulatory guidelines provide recommendations, they live room for flexibility in the design and setup of audit trails. As an example, the EMA ‘Guideline on computerized systems and electronic data in clinical trials’ requests that “the audit trail should show the initial entry and the changes (value - previous and current) specifying what was changed (field, data identifiers) by whom (username, role, organisation), when (date/timestamp) and, where applicable, why (reason for change)”*. Such requirements are straight forward in some areas but leave room for interpretation in others.

This lack of specificity has been subject to difficulty in implementing interpretable audit trails by eClinical vendors. For example, should audit trails also include automated system actions, such as system-generated timestamps or background processes? Including too little information risks non-compliance, while including too much can overwhelm the audit trail, making it unwieldy and difficult to navigate.

The impact of overcomplicated audit trails

An overly detailed audit trail may create more problems than it solves. If inspectors have to sift through extensive logs of irrelevant or repetitive information to find critical data, the purpose of the audit trail – to provide clarity and accountability – is defeated. This can lead to:

• Inspection delays: Inspectors may need additional time or assistance to locate specific information, causing disruptions.

• Increased workload: Trial teams may need to invest significant time in curating and explaining the audit trail, potentially making mistakes when pressurized by an on-going inspection.

• Missed insights: Important data points can become buried in an avalanche of unnecessary details, increasing the risk of findings or questions about data integrity.

Fulfilling the need for regular audit trail reviews

Readable audit trails are not just a convenience; they are essential for trial teams to comply with regulatory requirements for audit trail reviews. According to the same EMA guidelines as above: "Procedures for risk-based trial specific audit trail reviews should be in place and performance of data review should be generally documented."*

When audit trails are poorly formatted or difficult to interpret, trial teams may struggle to perform these required reviews, leading to gaps in documentation and potential compliance risks. Readability ensures that reviewers can efficiently identify and evaluate key data changes, supporting both risk-based monitoring strategies and successful inspections.

 Additional challenges with audit trails

Beyond accessibility and readability, other common challenges include:

• System usability: If the audit trail feature is hard to navigate, trial teams may struggle to utilize it effectively during routine monitoring or audits.

• Data visualization: Without clear formatting, such as tabulation or sorting options, audit trails can appear as incomprehensible blocks of text.

• Cross-functional visibility: Ensuring that audit trails are accessible to both internal teams and external inspectors can be a logistical hurdle.

• Scalability: As trials grow in complexity, audit trail systems must handle increasing volumes of data without compromising performance or usability.

CRScube’s approach to audit trails

At CRScube, we recognize the importance of balancing regulatory compliance with practical usability. Our solutions address these challenges with simplicity, designed to make audit trails both human-readable and readily accessible:

• Tabulated and on-screen: Audit trails in our data capture solutions are presented in a clean, tabular format, ensuring clarity and ease of use. Each entry includes the essential details of who made a change, what was changed, and when it occurred – meeting regulatory requirements without overloading the user with extraneous information.

• Accessible in multiple areas: Audit trail data is available directly within the platform’s interface, allowing users to access relevant audit trail data from various parts of the system. This ensures that critical information is always at the user’s fingertips.

• Simple navigation: Filtering options allow users to quickly locate specific data points, minimizing the time spent searching through logs.

By combining simplicity with robust functionality, our audit trails allow timely review of audit data during inspections and routine reviews, without any burden to the trial team or site users, making compliance that much easier.

* Guideline on computerised systems and electronic data in clinical trials, EMA/INS/GCP/112288/2023