What Is A TMF Certified Copy?

By Gillian Gittens, Director of eClinical Strategy and Solutions, Trial Interactive, TransPerfect

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. Continue reading for answers to the most frequently and commonly asked questions about the certified copying process for TMFs.