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?
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
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
ICH GCP E6(R2) – see in particular guideline
- 1.63 Certified Copy