General Concepts with Regard to Quality Control/Quality Assurance in Data Management

Abstract

Since the quality assurance system mentioned in the guideline for good clinical practice (GCP) for trials on medicinal products in the European Community is all too often limited to the data verification by clinical research monitors, the requirement to establish a quality system is placed in a broader perspective and extended to all data management activities. To implement a full quality system, commitment by management is required. Quality control/quality assurance (QC/QA) can only be effective in data management if the resources are provided to in-process personnel to perform validations through in-process quality control and to the independent QA audit group responsible for in- and post-study auditing.