Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making Workshop Report (1999) / Chapter Skim
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1Executive Summary The goal of improving health through the use of new medicines and medical devices cannot be achieved without public confidence and participation in the clinical trials process. During clinical development, investigational therapies are tested with human subjects, yielding essential information for assessments of their safety and effectiveness.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS2 The Roundtable on Research and Development of Drugs, Biologics, and Medical Devices convened a workshop on April 14 and 15, 1998, to discuss these and related topics. Representatives of major parties with vested interests in new medical product development were included.
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EXECUTIVE SUMMARY 3 site. This training is critical to ensuring that the protocol is followed correctly and that case report forms are properly completed.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS4 FDA Clinical Study Audit Program During application review, FDA selects clinical sites that generated data for the application for auditing purposes. A thorough on-site review of these sites is conducted by trained FDA inspectors.
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EXECUTIVE SUMMARY 5 a disincentive to maintaining high quality in clinical trials. The interrelated aspects of financial reimbursement and incentives, as well as scientific conduct in clinical trials, deserve further discussion.
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ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS6 Improvements In Quality Control and Quality Assurance Methods Benchmark standards ae developed for data quality in the clinical trial setting. A significant amount of effort goes into detecting and correcting problems, such as missing data points and transcription errors, which are very different from uncertainty issues.
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