We are being asked to ensure that any participant identifiable information be archived separately from pseudo anonymised /case report forms (CRF) data by placing the information in a clearly marked sealed envelope.

I understand that we don't need to redact patient identifiable information as secure archiving fulfills confidentiality required by GDPR and Clinical Trial regulations. Does the same principle not apply and we shouldn't be required to separate patient identifiable information from CRFs. If correct can anyone provide back up information to support this as it seems a lot of work to separate documents if not required.