Critical Steps for Writing an Impactful Clinical Audit Report

The amount of detail required in an audit may vary – ranging from an executive, high-level summary with detailed observations, to an exhaustive, all-inclusive report. A report may only include detailed observations, but it might also provide a list of all the documents reviewed, describing all processes reviewed in detail, along with any audit observations. While it’s critical for the auditor to understand the expectations of whom they are writing the report for, an impactful clinical audit report includes critical information to describe the status of the auditee in a factual way while excluding information that does not add value to the audience.

As defined in ICH E6 (R2), an audit is “a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).”

The audit’s output and report are written evaluations of the audit’s results. A typical audit report contains the following sections:

• General information, including who was audited, what was audited, and where the audit occurred
• Executive summary
• Summary of observations (typically in table format)
• What regulations and guidance the audit was conducted against
• Audit scope
• List of staff involved/interviewed in the audit
• Documentation reviewed during the audit
• Narrative section for describing topics covered and facilities reviewed during the audit
• Detailed observations

Industry standards are shifting to focus on building quality into studies and determining critical-to-quality factors (ref. ICH E8 R1) and an appropriate risk management approach (ref. ICH E6 R2). The audit report should identify how quality and risk management are managed throughout the entirety of the study conduct.

Critical Steps: Executive Summary

The executive summary succinctly describes the audit’s key points. This gives the audience — especially senior management — the key information and audit outcome. It should include whether it is a routine or for-cause audit, site/vendor identification, dates of audit conduct, and if there were any significant concerns or major findings. Research teams need to include a summary of these findings and an overall statement of compliance and acceptability. They should also indicate if the audit was conducted as planned, and if not, it should state the reason for any deviations from the audit plan.

Critical Steps: Observations

Observations are graded relative to the level of non-compliance or deviation. An example of this is formatting observations as critical, major, minor, or recommendation. The definitions of these are usually described in an audit’s SOPs or detailed in the report template. The definitions are based on the impact or potential to subject safety, data integrity, and the protection of human subject rights.

Multiple major audit observations may result in a systemic critical audit observation, even though each of the major observations are not “critical” themselves. Similarly, the same can be said for multiple minor observations, which may result in a major observation. Potential critical observations must be escalated – usually within 24 hours – to a client, so they can take appropriate action right away. Ideally, reports should be reviewed to ensure consistent observation grading and categorization, providing an objective perspective to verify the report is complete and clear.

Observations should be structured clearly. Typically, they start with an overarching statement of the non-compliance, followed by a detailed description of the issue with examples, and references for non-compliance (e.g., applicable regulations, guidelines, SOPs, protocol, or other study-level plans). The details provided must be factual and not based on subjective information.

When describing the critical and major observations, it’s important to also provide an impact statement. This details how the observation potentially impacts patient safety, their rights, data integrity, etc. Critical and major observations require root cause investigation and corrective and preventive action (CAPA), as ICH E6 R2 addendum section 5.20 requires. Minor observations usually only require correction. Observations must stand alone as the auditee will likely receive them separately from the report. The details in the observation must allow for the auditee to understand the observation and enable them to take action to rectify it.

Critical Steps: Trending

In addition to grading observations, observations should also be categorized – and subcategorized if need be – so trending can be performed. Trending is important to understand the organization’s health, giving visibility to repeat or systemic issues. Instead of raising an observation for each individual discrepancy, similar issues should be grouped in one observation wherever possible, instead of surfacing an observation for each individual discrepancy. For example, instead of creating an observation for a missing ethics committee (EC) letter, and another observation for a missing protocol signature page, these can be grouped under investigator site file/essential documents.

Critical Steps: Narrative

The narrative section of the report is where there are differences in the level of detail required by each organization. A best practice is to evaluate what would be value-added for a particular audit and understand the audience who will read the report. Providing too much information may take away from the site’s or vendor’s status. Some examples include:

• For a site audit, it would be relevant to detail the impact of COVID-19, as this could have resulted in missed patient visits or procedures. Facilities also may not have been available for routine patient visits, monitoring visits, or audits
• For a site audit, a detailed description of the facilities and processes relevant to clinical trial’s conduct (e.g., pharmacy, investigational product administration or infusion of investigational product, laboratory sample, and processing) must be included
• For a vendor audit, it may not be practical to describe company background/mergers in detail if the clinical or procurement team can be easily obtained from the internet
• The clinical team may be familiar with the procedures necessary in the protocol; therefore, each step of a procedure does not need to be described in detail, but rather a high-level description would suffice. If any issues with the process or procedure are identified, the narrative references in the observation section rather than including that deviation detail in the narrative
• Noting each reviewed narrative document can distract from the overall activity of the electronic trial master file (eTMF) or investigator site file (ISF) review activity. Staff can note their review for the eTMF and ISF and list any issues in the observation section or on a separate addendum to the report

Providing the correct level of information in an audit is a delicate balance. Critical to successful audit report writing is to understand the report’s audience, the essential information needed for the audience – site or vendor – to execute the plan, as well as sufficient detail allowing for a full understanding and a chance for observation correction.

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