Controlled Clinical Trials is an international journal that publishes manuscripts pertaining to the design, methods and operational aspects of clinical trials. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioral science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words in the following subject areas will be published: Unusual design features of specific trials that may be applicable to other studiesOrganizational structures that facilitate multicenter investigationsGeneral or specific design and operating features of data processing systems used for maintaining data bases in clinical trialsMedical, legal, and ethical issues in the conduct of clinical trialsManagement of multicenter investigationsMethods for assessing patient adherenceDesign of case report forms and other data collection methods for clinical trialsQuality assurance procedures for error detection in the data generation and processing procedures in clinical trialsData auditing practices in clinical trialsMethods for collecting and reporting adverse event data in clinical trialsRegulatory requirements for clinical trialsPatient involvement in the design of clinical trialsStatistical methods for clinical trialsHistorical review of clinical trialsMethods and case examples of monitoring clinical trials for evidence of adverse or beneficial treatment effectsCost assessment of procedures used for data generation, processing, and auditing in clinical trialsAssessment of the impact of clinical trials on the practice of medicineAs the official journal of the Society for Clinical Trials, Controlled Clinical Trials consistently addresses the needs and interests of clinicians and technical personnel responsible for the mounting and monitoring of clinical trials. For more information about the Society for Clinical Trials, visit their homepage at URL:http://www.sctweb.org/.