Operating Model and Governance Domain of the Clinical Trial Disclosure Maturity Model

Article 6 in our Maturity Model series

Executive Summary

Disclosure process management is the systematic way of organizing and carrying out activities related to clinical trial disclosure. This includes creating, implementing, and overseeing clear and consistent processes for the accurate and timely disclosure of clinical trial information. Disclosure process management is not merely an administrative task but the foundation of effective clinical trial transparency. Strong performance in this domain is a prerequisite for consistent, efficient, and compliant disclosure practices. By implementing standardized processes, organizations can minimize errors, improve efficiency, and consistently meet regulatory requirements.

Why this domain matters

The disclosure process management domain is the operational core of clinical trial transparency efforts. It shapes how organizations execute their disclosure activities, from initial planning to final publication. Effective process management ensures disclosure tasks are performed consistently, efficiently, and in compliance with regulatory requirements, regardless of the complexity of the trial or the variety of disclosure obligations. Well-defined disclosure processes are essential for several reasons:

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