This article is written by Elizabeth Bodi and Mike Lynch.
Clinical trial audits serve as a tool to assess if a given auditee has the required qualifications and capabilities to conduct a set of tasks. Auditing assesses standards and regulations that have or will be met. Clinical trial activities may be delegated to vendors or suppliers, including Contract Research Organizations (CROs), sample processing laboratories, Contract Development and Manufacturing Organizations (CDMOs), imaging laboratories, Central Institutional Review Boards (IRBs), etc.
In addition, audits can be used to verify the processes are followed, serving as a robust demonstration to health authority representatives that auditees are compliant and that processes impacting data integrity and patient safety have been thoroughly evaluated and vetted. Systematic audits instill confidence and assure regulatory bodies that the clinical trial sponsor maintains a vigilant oversight over every aspect of their clinical development program.
While clinical trial audit programs can be tailored to support a sponsor’s requirements and goals, it is especially important to have a focused approach when conducting routine (data) audits (i.e., investigator site audits, Trial Master File audits, data management (vendor) audits, etc.) There are additional tools and tactics to identify data outliers that may pose a risk to their development program more efficiently.
While attending the 2024 SCOPE summit, we listened to many sessions under the quality and monitoring and data tracks that resonate with our approach and client interactions. For example, assessing effective approaches for sponsors to review their data, identify outliers, and then remediate and act accordingly, are frequent conversations we have with industry.
Coming out of the summit, we are even more encouraged to recommend ways to elevate clinical trial auditing practices to a more proactive approach. For example, by leveraging artificial intelligence (AI) and central monitoring (CM) generated data, sponsors (and auditors) may get a head start by reviewing AI or CM-generated information and proactively focus their data reviews in advance of their audit. We believe that if auditors are more equipped with the issues and risks in advance of the audit, they can conduct a more targeted data review and proactively identify potential non-compliances or observations. Here are our observations and recommendations.
Leveraging Artificial Intelligence and Central Monitoring Outputs for Audit Preparation
At SCOPE, there were numerous sessions on AI use cases across the life sciences industry, many of which focused on how to maximize the value of a company’s data.
A common use case presented across these sessions was how to interact with the data using a more natural language where data analysis no longer needs to be done by data managers or statistical programmers. In a Chat GPT fashion, data reviewers could tell AI what data they wanted to see and how they wanted to see it. The data reviewer could then review the returned data set and drill down further without being required to write complex queries in a programmatic language.
Leveraging AI to automate repetitive tasks was another prevalent theme during these sessions. Tasks, such as data analysis, can be accelerated with the identification of patterns and trends with machine learning, deriving actionable insights. Leveraging AI for data analysis also increases accuracy in finding outliers that were missed during human review to identify potentially missing data.
This capability resonated with another repetitive task that is often overlooked or an afterthought until it is time for an audit – audit trail reviews. Audit trail reviews are key for a data integrity program to ensure the data is fully controlled, accurate, and complete; and until a problem has been identified, this activity does not always happen since it is generally a large data set that looks as expected. But this is a perfect use case for AI where a large data set can be analyzed by AI and outliers can be identified such as a user deleting a record with no reason documented or a user modifying a record that should not have access to that record.
With the U.S. Food and Drug Administration’s (FDA) March 2023 draft guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations stating that sponsors, clinical investigators, and other regulated entities may be requested to provide all records and data needed to reconstruct a clinical investigation, including metadata and audit trails, it is clear this is a must-have.
Utilizing CM data outputs to inform your clinical trial audits can make the selection of investigator site to audit straightforward. When preparing for an investigator site audit (ISA), the auditor may leverage CM metadata to select outliers to explore (i.e., investigator sites with high Serious Adverse Events (SAEs), protocol deviations, open action items, and data discrepancies) and zoom in on areas of risk efficiently.
So, why not leverage AI to inform audit preparation and CM metadata to have more focused audit conduct by zooming in on the key outlier data to proactively identify and resolve areas of risk that may affect your clinical trial? The time is now.
About Halloran’s Audit and Oversight Services
At Halloran, we understand navigating the complexities of clinical trial audits requires precision, expertise, and a commitment to meeting the unique needs of our clients. Partnering with us will elevate your audit experience:
Customized Audit Program Management and Execution:
We pride ourselves on tailoring audit programs to your organization’s specific goals, objectives, and timelines
Comprehensive Audit Support Throughout the Lifecycle:
From inception to closure, we are your dedicated partner throughout the entire audit lifecycle. Our team doesn’t just develop programs; we stand by your side, offering unwavering support at every stage
Client-Centric Approach:
Your success is our priority. We craft programs aligned to your unique challenges and objectives to add the most value
To discuss your audit strategy and approach, contact us today.