title: The research team, calibration, and quality assurance in clinical trials in periodontics.
abstract: The present report provides an overview of practical issues related to training, calibrating, and monitoring the individuals involved in conducting a clinical trial. These aspects are considered in relation to a theoretical multi-center clinical trial designed to test the safety and efficacy of a new periodontal treatment. Many factors need to be controlled in order to reduce inherent variability and provide standardization across the study population and study centers in a large-scale multi-center clinical trial. Components incorporated to control these factors include identification and recruitment of study centers, pre-study training and organization of the teams at the different research centers, quality assurance procedures and monitoring of the study for compliance with protocol and safety requirements, and management of databases. Details are given regarding the use of pre-study survey questionnaires to assess research center capabilities, methods for training and calibrating examiners and therapists and methods for integrating these aspects prior to actual study commencement, and quality assurance after the study has begun. The review considers the critical practical details regarding all of these aspects of study organization and execution.
authors.affiliation: Department of Periodontology, School of Dental Medicine, University of Pennsylvania, Philadelphia, USA.
authors.forename: A M
authors.initials: AM
authors.lastname: Polson
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards*; D015588:Observer Variation; D010348:Patient Care Team; D010510:Periodontal Diseases / Q000628:therapy*; D010517:Periodontics / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000592:standards*; D012107:Research Design; D012108:Research Personnel / Q000193:education / Q000592:standards*; D011795:Surveys and Questionnaires