July 15, 2020
A model approach to apply Risk-Based Monitoring, to direct monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data quality. Supported by a suite of tools to facilitate implementation, including a library of >100 risk indicators which sponsors may choose to apply in…
Explore
July 15, 2020
These tools delve deeper into the metrics for measuring RBM impact.
Explore
July 15, 2020
“Implementation considerations for establishing quality tolerance limits (QTLs) and risk reporting in the clinical study report (CSR) are examined and described. This framework aims to be consistent with ICH E6 (R2) and TransCelerate papers on Risk Based Monitoring (RBM) and Quality Management System (QMS).”
Explore
July 15, 2020
Describes a framework for effective risk management within clinical development. Assists organizations in understanding the benefits and basic components of risk management in clinical development. Includes a suite of change management tools.
Explore
July 15, 2020
A proposed framework describing flexible protocol deviations management approaches, elements for consideration based upon proposed interpretation of the ICH E3 definition for important protocol deviations and other associated PD Guidance with links to the PD Process Map.
Explore
July 15, 2020
A map of the protocol deviation management process containing processes for both important and non-important deviations.
Explore
July 15, 2020
Describes a framework for effective knowledge management within clinical development. Includes a suite of change management tools.
Explore
July 15, 2020
A template to assist in the identification and documentation of protocol-specific “important” deviations.
Explore
July 15, 2020
Describes a framework for effective processes management within clinical development. Assists organizations in understanding the benefits and basic components of process management for clinical development. Includes a suite of change management tools.
Explore
July 15, 2020
Provides an overview of the TransCelerate RBM initiative’s original vision for specific metrics with the potential to effectively measure the value and impact of RBM from multiple perspectives and an analysis of how those original, suggested metrics have been put into realworld practice.
Explore
