Legendary designer Coco Chanel famously said about fashion, “If you want to be original, be ready to be copied.”

When it comes to trial master files (TMFs), questions about original documents and copies are raised more than any other topic. A lot of confusion surrounds two factors: what constitutes a certified copy and when a certified copy is required.

While recent regulatory guidance has helped determine best practices that eliminate some of this confusion, questions still remain. Below are answers to the most frequently and commonly asked questions about the certified copying process for TMFs.

What Is A Certified Copy?

The Food and Drug Administration (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 of the same attributes and information as the original.”

Why Do You Need A Certified Copy?

According to the European Medicines Agency (EMA), “The ICH GCP guideline requires that copies (irrespective of the media used) in the eTMF that irreversibly replace originals should be certified copies of the original. Any transfer or conversion (e.g. digitization or printing), which does not fulfill the criteria for a certified copy, is not suitable to replace an original file.”

In other words, if an original document is destroyed by accident or deliberately, the copy filed in the eTMF must be a certified copy.

How Do You Verify An Exact Copy?

Verification is signing and dating to attest that a copy was produced through a validated process that ensures a copy contains the same information as the original, including data about the document’s context, content, and structure.

What Is A Validated Process?

This is where regulatory guidance becomes vague. EMA guidance has defined steps for the quality control (QC) of certified copies and says the process of digitization should be validated to ensure no information is lost or altered, but offers no further direction.

Validation is testing whether something works, documenting what was done, when it was done, and what happened.

The DIA Document and Records Management (DRM) community has produced a comprehensive framework around the paper destruction process, which also provides more direction on a validated process. The framework states, “A quality driven validated process should be established for image quality, indexing quality, metadata accuracy, and the establishment of the certified copy. Monitoring of the validated process needs to be documented. If completion of QC steps is being documented electronically, an audit trail and/or electronic signature functionality is to be implemented as part of the overall validation of the system.”

In short, a validated process is a tested, reliable, quality-driven set of actions defined by a standard of procedure (SOP) on which staff are trained.

What About Site Documents?

Since a trial’s investigator site file (ISF) is part of the TMF, the same principles apply for site documents. Original site-generated documents should remain at the site. If required, copies should live in the sponsor’s TMF. However, those copies do not need to be certified copies, because the original is not getting replaced or destroyed.

Not every copy in the TMF must be a certified copy. A copy only needs to be certified if it permanently replaces a destroyed original.

By relying on guidance from regulatory organizations like the FDA and EMA, and referring to the questions and answers above, you can more confidently determine when you need certified copies and how to properly create them.

How Can You Create a Certified Copy?

Many eTMF systems now have a certified copy capability, including Trial Interactive’s (TI) eTMF. The latest version of TI introduced the ability to ensure a certified copy workflow. With this feature, users can upload a document in a room with the certified copy capability enabled, verify the document uploaded, and review copy certification text before providing credentials to certify the document. Users can review a certified document and view the details related to that certification. This feature also works in the myTI mobile app.

For help with certified copies or other TMF and clinical document supports, contact us at info@trialinteractive.com.