Quality Assurance and Educational Standards for Clinical Trial Sites

Article two in this Journal of Oncology Practice (JOP) series, "Good Clinical Practice Research Guidelines Reviewed, Emphasis Given to Responsibilities of Investigators,"September 2008, described Good Clinical Practice (GCP) research guidelines, placing them into historical perspective, and discussed specific aspects of implementing the guidelines through the use of trained research professionals and wellwritten Standard Operating Procedures (SOPs). This series was inspired by publication of an American Society of Clinical Oncology (ASCO) statement in the May 20, 2008 issue of the Journal of Clinical Oncology, "American Society of Clinical Oncology Statement on Minimum Standards and Exemplary Attributes of Clinical Trial Sites,"and described in the July 2008 issue of JOP. This third article discusses two of the exemplary attributes of clinical trial sites suggested in the ASCO statement-quality assurance and formal maintenance of high educational standards-and describes the contribution of these attributes to the optimum functioning of an effective clinical trial site.