Jacqueline Gough1, Brett Wilson2, Mireille Zerola3, Phil Wallis4, Laila Mork5, David Knepper6, Heather Achenbach7. 1. 1 Clinical Risk Management, Eli Lilly and Company, Indianapolis, IN, USA. 2. 2 Global Development Operations, Research & Development, Bristol-Myers Squibb, Princeton, NJ, USA. 3. 3 Biometrics and Data Management, Boehringer Ingelheim, Bracknell, Berkshire, United Kingdom. 4. 4 Global Development Operations, Research & Development, Pfizer, Groton, CT, USA. 5. 5 Global Clinical Trial Management, Drug Development Operations, Allergan, Irvine, CA, USA. 6. 6 Business Operations, Allergan, Jersey City, NJ, USA. 7. 7 Clinical Trial Management, Novo Nordisk Inc, Plainsboro NJ, USA.
Abstract
BACKGROUND: TransCelerate's model approach to risk-based monitoring (RBM) includes the application of the appropriate monitoring activities to enable both the early detection and timely resolution of issues. This article is a follow-up to part 1, published in the September 2014 issue with the same title. METHODS: The intent of this paper is to share information on what has been learned by various companies' applications of central monitoring activities based on different RBM operating models. A library of risk indicators has been created, and this paper provides additional guidance on what has been learned in the application of these tools. RESULTS: The goal is to share the needs related to people, process, and technology as experienced by TransCelerate member companies. CONCLUSIONS: One of the primary issue detection methods of central monitoring is the proactive identification of areas of focus through the use of risk indicators.
BACKGROUND: TransCelerate's model approach to risk-based monitoring (RBM) includes the application of the appropriate monitoring activities to enable both the early detection and timely resolution of issues. This article is a follow-up to part 1, published in the September 2014 issue with the same title. METHODS: The intent of this paper is to share information on what has been learned by various companies' applications of central monitoring activities based on different RBM operating models. A library of risk indicators has been created, and this paper provides additional guidance on what has been learned in the application of these tools. RESULTS: The goal is to share the needs related to people, process, and technology as experienced by TransCelerate member companies. CONCLUSIONS: One of the primary issue detection methods of central monitoring is the proactive identification of areas of focus through the use of risk indicators.
Entities:
Keywords:
central statistical monitoring; organizational structure; risk indicators; risk-based monitoring
Authors: Sally P Stenning; William J Cragg; Nicola Joffe; Carlos Diaz-Montana; Rahela Choudhury; Matthew R Sydes; Sarah Meredith Journal: Clin Trials Date: 2018-08-22 Impact factor: 2.486