The Challenge of Auditing Clinical Laboratories

Abstract

Three types of clinical laboratory audits—local (clinical trial center), core, and central laboratory audits—are conducted by the Roche Pharma Research Quality Assurance (PRQA) Department. All laboratory audits are designed to determine if the laboratory data are reliable and verifiable, if there are adequate procedures and facilities, and to clarify the status of reference ranges and source document archiving. Audits are conducted on the basis of the good clinical practice (GCP) guidelines and regulations (1,2); national laboratory requirements, for example, Clinical Laboratory Improvement Amendment (CLIA) regulations (3) or the “Guide de bonne exécution des analyses” (GBEA) (4); and, where applicable, international principles of good laboratory practices.

The approach of the three audit types together with their common audit findings is described below. It was found that each type of clinical laboratory audit had revealed its own characteristic audit findings. Follow-up actions were implemented both by the clinical laboratory and the sponsor. For example, Roche's Clinical Research Department is now requiring a precontract audit before most agreements with core/central laboratories as well as follow-up, during-contract audits with preferred central laboratories. Improved quality and greater efficiency were achieved when all partners on the team (clinical research, clinical laboratories, and quality assurance) worked together.