Your Easy Guide to Clinical Studies

A certified copy is a copy of a primary document with the guarantee that the copy is a true and complete reproduction of the primary document.

 

Irrespective of the type of media used (e.g. photocopy) certified copies:

• Are only copies made from original documents
• Have the same information, content and structure as the original document
• Do not certify the authenticity or correctness of the original document but can only certify that the copy is a true copy

 

After having generated a certified copy, an original document can be destroyed. There are exceptions to this rule. Original documents containing wet-ink signatures must be retained. These documents are considered official records, where proof of authenticity can only be ascertained based on the original document

As a SP-INV/Site-INV, make yourself familiar with:

• Instances where certified copies become necessary (e.g. migration from a paper-based TMF/ISF filing system to an electronic filing or archiving system)
• Required procedures needed to confirm that a copy is a true copy of an original document, such as:
  • A person checks and verifies that the primary- and copy document are identical (e.g. the person signs and dates the copied document)
  • The set-up a validation process that guarantees the generation of true copies

References

ICH GCP E6(R2) – see in particular guideline

• 1.63 Certified Copy