The Reporting and Metrics Domain of the Clinical Trial Disclosure Maturity Model

Article 8 in our Maturity Model series

Executive Summary

The reporting and metrics domain focuses on measuring, analyzing, and communicating the performance of clinical trial disclosure activities. It encompasses the development of key performance, the creation of insightful reports, and the ensuring of data integrity. Relevant metrics and reports enable organizations to track compliance, identify areas for improvement, and demonstrate the value of their disclosure efforts.

Why this domain matters

Effective reporting and metrics form the foundation for data-driven decision-making in clinical trial disclosure. Clear visibility into disclosure performance and compliance status enables organizations to identify improvement areas, allocate resources efficiently, and demonstrate the value of transparency efforts. Well-designed metrics drive continuous process enhancement, helping sponsors adapt to evolving regulatory requirements and enhancing an organization’s ability to respond to audits or inquiries. In a complex disclosure landscape, the ability to measure, analyze, and report on disclosure activities is both a regulatory necessity and a strategic advantage, allowing sponsors to optimize processes, mitigate risks, and build trust with stakeholders:

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