From an all-inclusive, exhaustive report to a high-level, executive summary with in-depth observations, the amount of detail required in an audit may vary. While a report may only include a range of observations, it may also provide a list of every document reviewed, describing every process reviewed in detail, as well as any audit observations.
Although it’s important for the auditor to understand the expectations of whom they’re writing the report for, a good clinical audit report comprises critical information to describe the auditee’s status factually while eliminating information that doesn’t add value to the audience.
Here, our clinical trial data management software expert offers a guide to writing an impactful clinical audit report.
The Executive Summary
The executive summary briefly describes the key points of the audit. This gives the audience, for example, the senior management, audit outcome and key information. It should consist of major findings, significant concerns (if any), dates of audit conduct, vendor/site identification, and whether it’s a for-cause or a routine audit. Research teams must include an overall statement of acceptability and compliance as well as a summary of these findings. They should also include if the audit was performed as planned. If not, reasons must be stated as to why it deviated from the audit plan.
Observations are graded relative to the level of deviation or non-compliance. For instance, formatting observations as a recommendation, minor, major, or critical. Usually, these definitions are detailed in the report template or explained in an audit’s SOPs. The definitions are based on the potential or impact on the protection of human subject rights, data integrity, and subject safety.
Besides grading observations, observations must be categorized – and if need be, subcategorized. This will help you perform trending. Trending is important as it gives visibility to systemic or repeats issues and helps you understand the organization’s health. Instead of raising an observation for every individual discrepancy, similar groups must be grouped in a single observation wherever possible. For instance, instead of creating an observation for a missing protocol signature page and another observation for a missing EC (ethics committee) letter, these can be grouped under essential documents.
In the narrative section of the report, there are differences in the level of detail required by every organization. Assess what would be value-added for a certain audit and understand the audience who will read the report. Offering too much information may take away from the vendor’s or site’s status.
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