Abstract
Central monitoring, on-site monitoring, and off-site monitoring provide an integrated approach to clinical trial quality management. TransCelerate distinguishes central monitoring from other types of central data review activities and puts it in the context of an overall monitoring strategy. Any organization seeking to implement central monitoring will need people with the right skills, technology options that support a holistic review of study-related information, and adaptable processes. There are different approaches actively being used to implement central monitoring. This article provides a description of how companies are deploying central monitoring, as well as samples of the workflows that illustrate how some have implemented it. The desired outcomes include earlier, more predictive detection of quality issues. This paper describes the initial implementation steps designed to learn what organizational capabilities are necessary.
Article PDF
Similar content being viewed by others
Avoid common mistakes on your manuscript.
References
TransCelerate. Position paper: risk-based monitoring methodology. http://www.transceleratebiopharmainc.com/wp-content/uploads/2013/10/TransCelerate-RBM-Position-Paper-FINAL-30MAY2013.pdf.
ICH. ICH harmonised tripartite guideline, guideline for good clinical practice E6(R1). http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html. Accessed April 18, 2014.
US Food and Drug Administration. Guidance for industry oversight of clinical investigations: a risk-based approach to monitoring. www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm269919.pdf. Accessed April 18, 2014.
Kirkwood A, Cox T, Hackshaw A. Application of methods for centralized statistical monitoring in clinical trials. Clin Trials. 2013;10:783–806.
Buyse M, George SL, Evans S, et al. The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials. Stat Med 1999;18:3435–3451.
Venet D, Doffagne E, Burzykowski T, et al. A statistical approach to central monitoring of data quality in clinical trials. Clin Trials. 2012;9:705–713.
Barnes S, Katta N, Sanford N, Staigers T, Verish T. Technology considerations to enable the risk-based monitoring methodology. Therapeutic Innovation & Regulatory Science. 2014. 2014;48:536–545.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
About this article
Cite this article
Wilson, B., Provencher, T., Gough, J. et al. Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Part 1. Ther Innov Regul Sci 48, 529–535 (2014). https://doi.org/10.1177/2168479014546335
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1177/2168479014546335