Risk-based Approach to Determine the Need for an Audit: In What Situations Should an Audit Be Performed?

Abstract

In clinical trials, the need for an audit should be determined using a risk-based approach as part of a quality assurance process. However, it is difficult to define clear evaluation criteria because various risks are associated with investigator-initiated clinical trials. For example, while several Japanese standards for the conduct of clinical trials suggest that an audit should be performed “as needed,” the exact meaning of “needed ” is unclear. Therefore, this study aimed to define indications that can be used by a principal investigator to determine the need for an audit.

We first examined prerequisites to simplify our risk evaluation. They were, 1）it is to be performed for individual clinical trials, rather than to act as a systems audit to examine facilities or functionalities, and 2）it is to be performed for clinical trials that satisfy quality control measures above a certain level. Based on these prerequisites, we then examined the risk factors that are generally considered in investigator-initiated clinical trials. The results revealed that the need for an audit increases when the outcomes of the trial can be biased by conflicts of interest, and when the study intervention is highly invasive, posing a safety concern to the participants. Other situations, such as the study design and quality management level, affect the need for an audit to a lesser extent. It should be noted that the need for an audit shall be appropriately determined for each actual particular trial with reference to these ideas.