Certified copy

A certified copy is a duplicate of an original document, such as case report forms, patient medical records, or regulatory submissions, that has been verified by an authorized individual or entity as a true and accurate representation of the original.

Definitions

ICH E6(R2)

1.63 Certified Copy:

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, including data that describe the context, content, and structure, as the original .

Regulations pertinent to certified copies

Requirements for certified copies in clinical trials are outlined in several regulations and guidelines.

21 CFR Part 11

This US regulation sets criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

EU Clinical Trials Regulation

EU requires that certified copies of documents, whether paper or electronic, must be generated and maintained in a manner that ensures their accuracy, reliability, and integrity.

ICH GCP

The ICH defines a certified copy as a copy that has been verified by a dated signature or by a validated process to produce an exact copy having the same attributes and information as the original.

ISO 14155

While the ISO standard for clinical investigation of medical devices for human subjects provides guidance on the certification of document copies, specific requirements may be more detailed in other related regulations or guidelines, such as those provided by the FDA or EMA.

Application to e-records

The concept of a copy also applies to electronic records. The certification process for e-records typically involves verifying that the electronic copy is an exact duplication of the original electronic document.

See also