CQA involvement in corrective action. In all companies, except one, CQA is informed about the planned corrective actions for findings requiring a response (i.e., all companies for all critical and major findings, 80% of the companies for minor findings too). In 90% of the companies the adequacy of the corrective actions is assessed by CQA. With regard to the completion of corrective actions, CQA is informed less frequently (70% for critical, 60% for major, and 40% for minor findings).

Three-quarters of the companies conduct checks/controls to find out if corrective actions were performed. However, the individual responses revealed that such checks do not occur via re-audit, but via either further routine audits, documentation review, or spot checks in case of critical findings. A formal audit closure statement is issued for 55% of the companies.

Response Time to Audit Reports

Three-quarters of the companies perform systematic trend analyses of audit findings across multiple investigator site audits. The frequency of trending varies considerably from company to company. However, about one-third evaluate data quarterly, another third annually, and the remaining companies either both or ad hoc.

Types of trend analysis. Twenty-two companies reported conducting trend analysis. The following analyses were conducted: across all audits, by study, by project, by therapeutic area, by region, by country, by phase, and by study type (eg., GP or hospital). About 80% perform analyses across all audits, and about 60% perform analyses for specific studies/projects. However, only one-third prepare an audit summary report per study that addresses the main audit findings for the study.

About 30% of the companies performing systematic trend analyses (6 out of 22) calculate an overall compliance rate across audits.

Although 25% of all companies (7 out of 28) have Quality Key Performance Indicators in place, only two of them use the overall compliance rates to calculate Quality Key Performance Indicator(s).

If trend analysis results are calculated (22 companies), about 90% use them to support process improvement, with senior management involved for most of these companies.

To put this into perspective, about 70% of all companies use trend analysis results to support process improvement.

Communication of trending results. Trending results are communicated by 90% of companies conducting trend analyses (n=22) to various functions outside of CQA. These functions are: management (18 companies), study teams (12 companies), project teams (10 companies), functions (e.g., PV) (16 companies), and investigators' meetings (4 companies).