The Risk Based Monitoring Initiative was established in 2012 as one of the five initial goals created by TransCelerate to drive efficient and effective solutions into the R&D industry. Clinical trial sites have varying levels of experience and quality, but monitoring approaches are not designed to manage potential differences. In fact, research indicates that 100% SDV is not effective at identifying material risk. Still, monitoring approaches remain unchanged.
By developing a model approach for risk-based monitoring of clinical trials, TransCelerate’s objective is to both enhance patient safety and ensure the quality of clinical data.
The resource solutions generated by the Risk Based Monitoring Initiative could lead to improvement in data quality and patient safety for clinical trials and reduction in effort expended on low-value activities. In addition, adoption of the Initiative’s approach to Risk Based Monitoring could lead to cost reductions through more focused centralized monitoring activity and targeted on-site monitoring.
To find out more our Information Materials, Methodology Papers and Initiative Updates click to our Initiative Assets below.
Quality Management System
Through partnerships with Health Authorities and other industry stakeholders, the Quality Management System (QMS) Initiative aims to explore ways to improve quality across the industry.
The eSource Initiative seeks to assist TransCelerate Member Companies, and ultimately other trial sponsors in overcoming real and perceived challenges to influence more efficient data gathering practices to benefit patients, sites and sponsors.
Clinical Data Transparency
The Clinical Data Transparency Initiative was formed with a mission of developing a model approach for redacting privacy information found in clinical study reports and a model approach for the anonymization of patient-level data shared with the broader healthcare community.