What is it? Why is it important?

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

What do I need to do?

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

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guideline

  • 1.63 Certified Copy
Abbreviations
  • CTU – Clinical Trials Unit
  • ISF – Investigator Site File
  • TMF – Trial Master File
Basic ↦ Documents ↦ Certified Copies ↦ Procedures
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Documents ↦ Certified Copies ↦ Procedures

Please note: the Easy-GCS tool is currently under construction.