A certified copy is a copy of an original record that has been verified to contain the same information, including relevant metadata. ICH E6(R3) allows for verification via a dated signature or generation through a validated process. The term is media-neutral: a certified copy can be in paper or electronic form.
Equivalence to the Original Record
The decisive criterion is not visual similarity, but proven information equivalence. For example, if handwritten laboratory values are digitized, the copy must reflect the values as well as the context necessary for their meaning. Where relevant, this includes metadata such as author, date, time reference, or the assignment to the participant and the study process.
A scanned page does not become a certified copy simply by being in PDF format. Only a dated confirmation or a validated process proves that the copy matches the original. The process used must therefore be designed so that its result can be traced for the respective type of record and does not merely generate a technical image file.
When Replacement Becomes Permissible
The certified copy takes on particular importance when it is intended to permanently replace an original essential record. In such cases, ICH E6(R3) requires the copy to meet the requirements for a certified copy. Consequently, an investigative site transferring its paper records to a controlled digital archive needs a documented conversion and quality process before destroying or handing over the originals.
The replacement concerns the record, not the professional decision documented within it. A certified copy of a signed delegation log makes its content accessible but changes neither roles, dates, nor validity. For inspections, it remains important that storage location, access, and retention are regulated so that the replaced record is available in the required context.
Distinction from Source Data Verification and Essential Records
Source Data Verification compares reported study data with its source records. For example, it checks whether a laboratory value reported in the eCRF matches the corresponding laboratory report. In contrast, a certified copy is itself a form of record that can represent an original in terms of content and metadata; it is not a verification step for data comparison.
Essential Documents refers to the fundamental evidence of a clinical trial. These can include originals and certified copies. Not every essential record needs to be copied, and not every file in an archive meets the requirements of a certified copy without proof of verification. This distinction becomes immediately practical when digitizing the study file.
Verification must also capture the time of creation and the completeness of the copying scope. For a multi-page informed consent document, it is not enough to confirm only the signature page; information pages, the version, and any translations are also part of the faithful reproduction. If the original contains corrections, marginal notes, or attached labels, the copy must not silently omit these features. A validated mass process can systematically ensure such checks, while in individual cases, dated confirmation creates the necessary chain of evidence.
A certified copy therefore differs from a mere working copy by its intended evidentiary value. Working copies facilitate, for example, the preparation of a monitoring visit without necessarily representing the original. If, on the other hand, a record is to be permanently available only digitally, it must be determined in advance who will verify equivalence, how errors will be handled, and what evidence must be retained for the transition.
The provision of evidence must cover the specific document class, not just the general capability of a scanner.
Relevance for clinical trials
In the event of site closure, archive migration, or a change in the document management system, the quality of the copy determines whether the documentary evidence persists. Records with handwritten additions, multi-page documents, signatures, and dates are particularly critical. If proof of equivalence is missing, electronic filing may facilitate access without replacing the original in a compliant manner.
Full-service CROs like Mediconomics provide support in defining conversion processes, sampling and acceptance criteria, as well as TMF or ISF migration planning. Quality Management, Clinical Operations, and Document Management can coordinate proof of process validation, the assignment of document classes, and the controlled transfer of digital assets for archiving.
Frequently Asked Questions (FAQ)
Is a signed copy without a date sufficient?
The ICH definition explicitly specifies a dated signature for verification by signature. If the date is missing, this method of documenting the copy has not been fully implemented.
Can a certified copy replace a paper original?
Yes, if it is intended to permanently replace the original and meets the requirements for a certified copy. The equivalence of information and relevant metadata must be verified.
Is a certified copy the same as a source record?
No. It is a verified copy of an original record. Whether it is used as the authoritative source in a specific data flow also depends on the specifications for the study.
Regulatory References
- ICH E6(R3), Good Clinical Practice – establishes the definition and requirements for permanent replacement with copies.
- EMA/INS/GCP/112288/2023 – addresses the integrity of electronic data and the control of computerized systems.
- EudraLex Volume 4, Annex 11 – requires risk-based controls for data integrity in the system lifecycle.
