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Certified Copies: A Guide to FDA, EMA, and More

August 07, 2023

Electronic Trial Master Files (eTMF) are becoming increasingly common among sponsors and CROs in the clinical trial sphere. eTMFs can help save time, money, and resources by minimizing the need for paper documentation and streamlining operations. Understanding the regulatory landscape for certified copies is critical for compliance as clinical trials continue to cross borders. Regulatory authorities such as the FDA, EMA, PMDA, Health Canada, and TGA may have different standards for certifying eTMF copies. This blog will provide an overview of certified copy regulations, highlight important distinctions between various regulatory bodies, and discuss recommended practices for producing certified copies.

The Role of Certified Copies in eTFMs

Many clinical trial documents are still documented on paper, typically with handwritten signatures. Transforming these papers to electronic format within eTMFs not only facilitates management and storage but also enables the eventual destruction of paper originals. Here's where certified copies come in handy.

A certified copy is an exact replica of an original document that has been validated. Both the FDA and the EMA define certified copies differently, but the essential notion is the same: a certified copy must contain all of the same information and attributes as the original document. Generating certified copies is critical for guaranteeing regulatory compliance and preserving the eTMF's integrity.

Comparing Certified Copy Requirements Across Regulatory Authorities

It is critical to grasp the differences and similarities in the rules set forth by various regulatory authorities when it comes to certified copies. While the overall concept of a certified copy stays the same, the methods of certification and specific standards may differ.

The FDA defines a certified copy as “a copy of original information that has been verified, as indicated by a dated signature, as an exact copy having all the same attributes and information as the original.” On the other hand, the EMA defines it as “a paper or electronic copy of the original document that has been verified (e.g., by a dated signature) or has been generated through a validated process to produce an exact copy having all the same information, including data that describe the context, content, and structure, as the original.”

The main distinction between the two definitions is the manner of certification. The FDA specifically emphasizes certification by signature, whereas the EMA allows certification by signature or through a proven method.

Furthermore, other regulatory bodies around the world may have their own standards for certified copies. To maintain global compliance in clinical trials, it is critical to keep informed of and adhere to these requirements.

Knowing the variations in regulatory authorities' norms and practices is critical for worldwide compliance. A table comparing the certification systems, document retention regulations, and language requirements for the FDA, EMA, PMDA, Health Canada, and TGA is provided below:

Comparison Table of Certified Copy Requirements

Regulatory Authority

Certification Method

Language Requirements

FDA (USA)

Verified copy with dated signature

English

EMA (Europe)

Verified copy with signature or validated process

English or local language

PMDA (Japan)

Verified copy with dated signature

Japanese

Health Canada (Canada)

Verified copy with dated signature

English or French

TGA (Australia)

Verified copy with dated signature

English

While some procedures are comparable across regulatory agencies, it is critical to be knowledgeable about each authority's individual rules and requirements to maintain global compliance in clinical trials. For the most up-to-date information, always reference the relevant authorities' most recent instructions.

Cracking the Certified Copy Code

Verified copies are critical to the successful use of eTMFs in clinical trials. Organizations may unleash the full potential of eTMFs by using best practices and adhering to regulatory rules, eventually saving costs and enhancing efficiency.

Octalsoft's eTMF software solution provides a digital platform and strategy for electronically capturing, organizing, sharing, and storing all critical documents, photos, and artifacts that develop over the course of a regulated clinical trial. The system includes the DIA TMF Reference Model, which enables users to organize their content according to a known taxonomy and structure. Built-in checklists and milestone tracking capabilities enable you to actively assess the completeness and compliance of any material in real-time.

Learn even more about Octalsoft eTMF here. Got questions or curious about how to leverage it in your studies? Book a Demo with us today!

Arun Janardhanan

Arun Janardhanan

This piece is co-authored by Nishan Raj, Senior Content Writer at Octalsoft.

Arun Janardhanan

This piece is co-authored by Nishan Raj, Senior Content Writer at Octalsoft.
Wherever there is the latest news, the newest culture shift, and the zaniest people, you are bound to find Mr. Arun Janardhanan, Senior Project Manager and Delivery Manager at Octalsoft. Arun discovered his love for technology early and quickly chose a career in IT. We at Octalsoft were lucky to scoop him up just in time before this jet setter zoomed off into the horizon. From ideating and innovating and on to managing executions of our products, critical to all strategic discussions, Arun is ever-present when it comes to developing new strategies, processes, structures, and organizational systems.

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