title: The future of monitoring in clinical research - a holistic approach: linking risk-based monitoring with quality management principles.
abstract: Since several years risk-based monitoring is the new "magic bullet" for improvement in clinical research. Lots of authors in clinical research ranging from industry and academia to authorities are keen on demonstrating better monitoring-efficiency by reducing monitoring visits, monitoring time on site, monitoring costs and so on, always arguing with the use of risk-based monitoring principles. Mostly forgotten is the fact, that the use of risk-based monitoring is only adequate if all mandatory prerequisites at site and for the monitor and the sponsor are fulfilled.Based on the relevant chapter in ICH GCP (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use - Good Clinical Practice) this publication takes a holistic approach by identifying and describing the requirements for future monitoring and the use of risk-based monitoring. As the authors are operational managers as well as QA (Quality Assurance) experts, both aspects are represented to come up with efficient and qualitative ways of future monitoring according to ICH GCP.
authors: GCP-QA-Consulting, Düsseldorf, Germany. e.ansmann@web.de
authors: Eva B
authors: EB
authors: Ansmann
authors: Arthur
authors: A
authors: Hecht
authors: Doris K
authors: DK
authors: Henn
authors: Sabine
authors: S
authors: Leptien
authors: Hans Günther
authors: HG
authors: Stelzer
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000191:economics / Q000639:trends; D026661:Clinical Trials Data Monitoring Committees / Q000191:economics* / Q000639:trends*; D002986:Clinical Trials as Topic / Q000191:economics* / Q000639:trends*; D003299:Cooperative Behavior; D017046:Cost Savings / Q000639:trends; D004282:Documentation / Q000191:economics / Q000639:trends; D004345:Drug Industry / Q000191:economics* / Q000639:trends*; D016903:Drug Monitoring / Q000191:economics* / Q000639:trends*; D015507:Drugs, Investigational / Q000009:adverse effects* / Q000627:therapeutic use*; D057286:Electronic Health Records / Q000191:economics / Q000639:trends; D005858:Germany; D006694:Holistic Health / Q000191:economics* / Q000639:trends*; D006801:Humans; D007318:Inservice Training / Q000191:economics / Q000639:trends; D033183:Interdisciplinary Communication; D061214:Patient Safety / Q000191:economics; D018579:Patient Selection; D011785:Quality Assurance, Health Care / Q000191:economics* / Q000639:trends*; D012017:Referral and Consultation / Q000191:economics / Q000639:trends; D018570:Risk Assessment / Q000191:economics* / Q000639:trends*; D017749:Total Quality Management / Q000191:economics / Q000639:trends*
chemical_list: D015507:Drugs, Investigational
keywords: monitoring; quality management; risk-based monitoring
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