Some Aspects of Digitalization and Digital Transformation in Clinical Research: Bridging TMF Completeness, Work Delivery, and Financial Recognition for Data Quality, Audit Readiness, and Financial Integrity.

This concept paper proposes a unified operational-financial framework in clinical research by aligning Trial Master File (TMF) completeness with revenue recognition practices. It suggests treating TMF documents as verifiable evidence of work completion, enabling a structured mapping of deliverables to the Work Breakdown Structure (WBS) and Gantt-based planning. The approach supports real-time operational visibility, audit readiness, and financial transparency by bridging contractual scope, project execution, and financial reporting.

Building on recent digital transformation trends, the article integrates insights from project management (PMBOK), regulatory expectations (ICH GCP E6(R3)), and financial accounting standards (IFRS 15 and ASC 606). 

The work complements a previously published budgeting framework and suggests that TMF completeness can serve as a central integration point across planning, operations, and finance.