Auditing under Multiple Standard Operating Procedures: The View of a Contract Research Organization

Abstract

Quality assurance in general has to confirm that any type of performance within the course of clinical trials is achieved at the specific quality level defined for this task in its standard operating procedures (SOPs). But who ensures that the sponsor's SOPs are fully compliant with good clinical practice (GCP) regulations and local requirements? Is it enough that an independent auditor only confirms that the audited individual work matches the quality standard defined by the company's SOPs? They might be inconsistent with applicable regulations. The unbiased reader of a mere audit certificate, however, could presume that this document implies GCP compliance, which might not be true at all. Would this dilemma oblige the auditor to audit the sponsor's SOPs first?

Another difficult situation arises if two or more contract research organizations (CROs) work together in conducting one multinational trial and their SOPs do not fully comply with the sponsor's SOPs. The worst case scenario would be if SOPs change during the conduct of a clinical trial, imaginable in connection with company mergers or a takeover. Practical solutions for the outlined problems and misconduct will be discussed.