SOP Deficiencies and Documentation Errors Dominate EMA GCP Audit Findings
Posted on: Thursday, July 16, 2015

In a report released by European Medicines Agency (EMA) earlier this month, auditors from the Agency found many clinical sites to have several major deficiencies in compliance with Good Clinical Practices (GCP). About 58% of the findings related to errors in study documents, either poor source documents or bad documentation practices, while about 15% findings were related to SOP errors. Auditors also found many instances of poor trial management by the sponsors including areas such as clinical monitoring practices, data management and poor sponsor audits. About 70% of the audits were conducted at clinical sites, with the sponsor offices and CROs accounting for about 22% of the audits. The clinical labs were the least likely to get audited with only about 3% of the total audits being of labs. These findings are very similar to those found by FDA during its audits thereby confirming that these issues are universal in nature and trial sponsors must pay attention to avoid negative findings about their trials. There are multiple resources to train personnel in SOP and documentation practices so these findings are truly avoidable.
 

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research