Certified copy

A certified copy is a copy of an original record that has been verified, either by a dated signature or through a validated process, as having the same information as the original.

Depending on the applicable standard, this includes relevant metadata and information describing the context, content, and structure of the record. A certified copy may be produced in paper or electronic form.

Definitions

The term certified copy is defined in several clinical research standards and guidance documents. The definitions differ in their treatment of metadata and the information that must be preserved.

ICH Good Clinical Practice

ICH E6(R3) defines a certified copy as:

A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information as the original, including relevant metadata, where applicable 1.

FDA guidance

The US Food and Drug Administration (FDA) defines a certified copy in its guidance Computerized Systems Used in Clinical Trials as:

A copy of original information that has been verified, as indicated by dated signature, as an exact copy having all of the same attributes and information as the original 2.

This definition appears in FDA guidance, but is not explicitly defined in 21 CFR Part 11.

Related terminology

  • Audit trail
  • Documentation
  • Source data

References

  1. International Council for Harmonisation. 2026. ICH E6(R3): Consolidated Guideline for Good Clinical Practice. Available at: https://database.ich.org/sites/default/files/ICH%20E6%28R3%29_Step4_FinalConsolidatedGuideline_2026_0616_.pdf ↩︎
  2. U.S. Food and Drug Administration (FDA). 2013. Guidance for Industry – Computerized Systems Used in Clinical Trials. Available at: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/guidance-industry-computerized-systems-used-clinical-trials ↩︎