Eliminating Clinical Trial Shadow Charts: Aligning with Current FDA and Global Guidelines

Shadow charts persistently plague clinical trials, creating inefficiencies and introducing audit risks. But what exactly is a shadow chart, and why are regulatory bodies and research sites focused on eliminating them?

Shadow charts are duplicate, unofficial document collections that develop alongside official clinical trial documents. They typically emerge due to disconnected or insufficient systems. Common examples include:

• Printing documents from Electronic Health Records (EHRs) for manual edits, signatures, or redactions, then rescanning them into trial portals, leaving behind duplicate or residual documents.
• Creating on-the-spot duplicate forms when original documents are inaccessible during patient visits.
• Sponsors’ monitoring teams duplicating documents across shared drives, emails, and separate storage solutions to keep pace with monitoring tasks.

These shadow charts may seem harmless, but they bring three significant challenges:

1. Administrative Burden: Constantly reconciling and editing multiple versions of documents adds significant manual labor and inefficiency.

2. Audit and Compliance Risk: Multiple, inconsistent document versions directly contradict Good Clinical Practice (GCP) guidelines, creating confusion and increasing the risk of regulatory inspection findings.

3. Remote Monitoring Difficulties: Shadow charts prevent effective remote monitoring by creating uncertainty about document completeness and authenticity. When multiple document versions exist across scattered systems, monitors cannot reliably verify data remotely, undermining regulatory expectations for transparent, efficient remote oversight.

Regulatory Momentum for Eliminating Shadow Charts

Global regulatory bodies recognize the issues caused by shadow charts and have clearly paved the way for their elimination by advocating electronic management and source documentation solutions:

• FDA eSource Guidance (Updated):
  The FDA continues to encourage electronic capture, management, and storage of clinical trial data and documents. FDA’s updated eSource guidance outlines best practices for maintaining electronic records to ensure compliance, data integrity, and seamless inspection readiness. The guidance explicitly allows electronic records as legitimate original source documentation, eliminating the need for duplicate paper charts.

• ICH E6 (R3) Updates (Current and Ongoing):
  The International Council for Harmonisation (ICH) is reinforcing and expanding guidelines through the latest ICH E6 (R3) revision. These updates further emphasize digital data integrity, risk-based monitoring strategies, and standardized electronic document management practices globally. Sponsors, CROs, and research sites are urged to adopt centralized, validated electronic document management systems to mitigate data management risks and eliminate shadow charts.

Why Sites and Sponsors Should Transition to Centralized Digital Systems

Given the regulatory framework now firmly in place, eliminating shadow charts is achievable and strategically beneficial. Implementing a unified electronic solution for managing clinical trial documents at sites and for sponsors delivers clear advantages:

• Reduced Administrative Overhead:
  Centralized document systems significantly lower the need for manual reconciliation and reduce repetitive tasks, enhancing operational efficiency.

• Improved Compliance and Audit Readiness:
  A single electronic source ensures version control, transparency, traceability, and full compliance with global regulatory standards, dramatically decreasing audit risks.

• Enhanced Collaboration and Remote Monitoring:
  Sponsors and research sites can collaborate seamlessly, enabling remote monitoring practices aligned with FDA and global regulatory recommendations for decentralized trial management.

Action Steps for Sites and Sponsors

To permanently eliminate shadow charts and align with current FDA and global guidelines:

1. Implement a Single Source of Truth:
   Deploy a validated electronic document management system designed explicitly for clinical research environments.

2. Digitize and Standardize Document Workflows:
   Establish electronic workflows that mirror regulatory expectations and eliminate paper dependencies entirely.

3. Ensure Regulatory Alignment:
   Continuously evaluate and ensure your processes align with evolving FDA eSource guidelines and ICH E6 (R3) standards, focusing specifically on risk-based, digitally enabled management.

Final Thoughts

The regulatory environment clearly supports—and even mandates—transitioning to comprehensive digital documentation systems. By proactively eliminating shadow charts through a unified electronic management approach, clinical trial sites and sponsors can streamline operations, ensure regulatory compliance, and mitigate significant operational risks.

It’s time to close the chapter on shadow charts—digitally.