Records vs. Documentation in Clinical Trials: A Terminology Shift Under ICH E6(R3)
In clinical research, precise terminology shapes compliance strategy. One of the most important shifts in the latest ICH E6(R3) Good Clinical Practice (GCP) guideline, finalized in January 2025, is the move from referring to “documents” to using the broader term “records.”As a result, this change directly impacts how clinical trial stakeholders manage the Trial Master File (TMF) and maintain GCP compliance.
What’s the Difference Between Records and Documents?
Documents
Traditionally, documents are dynamic, working files created and edited during the course of a clinical trial. Examples include:
- Protocols
- Investigator brochures
- Monitoring visit reports
- Ethics committee approvals
These are typically managed via Document Management Systems (DMS) and go through creation, review, version control, and approval workflows.
Records
Furthermore, records are final, immutable evidence of trial activities and data integrity. Under ICH E6(R3), examples of records include:
- Finalized documents, like protocol
- Audit trails
- Metadata
- eSource data
- Logs and timestamps
- Signatures
Compared to documents, records are broader, more inclusive, and designed for traceability across the entire trial lifecycle.
ICH E6(R3): Why the Shift Toward Records Matters
Importantly, the shift in language reflects evolving regulatory expectations and aligns clinical trial oversight with broader data governance frameworks. In addition, it signals a deeper industry shift toward managing data integrity across systems and formats.
🔍 Key Updates in ICH E6(R3):
- Section 2.1: Data Governance refers explicitly to “records and data” as primary assets.
- Annex 1 replaces the older “essential documents” list with a focus on “essential records” required for trial evaluation.
In doing so, the guideline expands the scope to include all formats of evidence, whether structured or unstructured, paper or electronic.
Comparison Table: Documents vs. Records
Why the Terminology Shift Impacts TMF Compliance
Clinical Teams:
- First, SOPs and TMF policies should now reference “essential records” instead of only “essential documents.”
- Second, teams must understand the recordkeeping lifecycle from creation to long-term retention and inspection-readiness.
- Third, training programs should reinforce the difference between managing draft content and preserving finalized records.
Quality and Compliance Officers:
- Records align with ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available.
- As a result, expect increased focus on metadata, audit trails, and digital provenance in inspections.
Technology Providers:
- Consequently, the industry is moving beyond Document Management Systems to Records Management Systems (RMS) that support:
- Metadata capture
- Version history
- Access logs
- Regulatory archiving standards
The Bigger Picture: Evolving Toward Risk-Based, Data-Driven Oversight
The updated terminology in ICH E6(R3) is not cosmetic—it aligns with a broader evolution in trial management. The shift acknowledges that modern trials generate diverse types of data and digital evidence that must be captured, preserved, and inspected as part of a unified clinical trial record.
In practice, this means:
- “Records” include more than PDFs or scanned documents—they span electronic source data, operational logs, and even system-generated artifacts.
- TMF stakeholders should adopt a risk-based approach to records management, prioritizing accuracy, traceability, and audit-readiness.
Conclusion: Every Document May Be a Record, But Not Every Record Is a Document
The move from “documents” to “records” in ICH E6(R3) marks a shift in how the industry defines evidence and compliance. While “documents” remain part of the operational language, “records” now form the regulatory backbone of GCP-aligned TMF strategies.
In today’s increasingly digital environment, as clinical trials grow more decentralized and digital, embracing the language—and principles—of records management will be key to future-proofing your trial operations.
FAQs: Common Questions About Records in Clinical Trials
1. Is “document” now an outdated term in GCP?
Not exactly. While still used in daily operations, “record” is now the preferred term for regulatory and audit purposes under ICH E6(R3).
2. Do I need to change my TMF SOPs?
If your SOPs refer only to “essential documents,” you should consider updating them to align with the new “essential records” terminology.
3. What’s the impact on inspections?
Inspectors will increasingly expect a traceable, audit-ready records lifecycle, including metadata, version control, and secure archiving—not just static documents.
Documents tell a story. Records prove it. At Just in Time GCP, we help sponsors build TMFs that stand up to scrutiny—clearly, completely, and on time. Whether you need help updating SOPs, streamlining records processing, or preparing for inspection, we’re here to support you every step of the way.
Click here for more details on how we can help you achieve clinical compliance confidence.
