Your Easy Guide to Clinical Studies

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

 

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

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

 

After having generated a certified copy, an original document/record can be destroyed.

 

There are exceptions to this rule. Original documents/records containing wet-ink signatures must be retained. These documents are considered official accounts, where proof of authenticity can only be ascertained based on the original document/record.

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

• Ensure that copies meant to replace original essential documents/records fulfil the requirements for certified copies (e.g. the migration from a paper-based TMF/ISF filing system to an electronic filing or archiving system)
• Make yourself familiar with the procedures needed to confirm that a copy is a true copy of an original document/record, such as:
  • A person checks and verifies that the original and copied document/record are identical (e.g. the person signs and dates the copied document/record)
  • The set-up a validation process that must be complied with, thereby guaranteeing the generation of true copies

References

ICH GCP E6(R3) – see in particular guideline

• Glossary: Definition certified copy
• Glossary: Definition of essential records
• C.2.9 Requirement for certified copies