Is a system backup an adequate archive?

Only if the actual arrangement meets the applicable accessibility, integrity and retention needs; do not assume equivalence.

Can a departing employee retain the only archive password?

No. Establish authorized institutional continuity and test retrieval before access changes.

Handing over clinical trial archive custody in Türkiye

Published: 27 October 2026
Updated: 27 October 2026
Sources checked: 27 October 2026

A file transfer is incomplete until the receiving custodian can retrieve the records and understands the continuing obligations. Türkiye study archives need a documented handover that survives staff changes and supplier transitions.

Define custody and record scope

TİTCK good clinical practice and application resources provide the local framework for study records. Confirm applicable retention and archive-service requirements for the actual record type and arrangement. Avoid copying a single number of years into every contract without checking the study, regulatory and institutional context.

Prepare an archive acceptance record

We recommend an acceptance record listing record groups, formats, date ranges, known gaps, custodian and authorized access roles. Include electronic metadata, audit trails and decryption or viewing dependencies where applicable. A folder count does not demonstrate completeness, and a backup does not automatically function as an accessible archive.

Check retrieval and access

Reconcile the inventory with the study file plan and document known missing records.
Test retrieval of a participant-related record, a decision history and a product accountability record.
Confirm confidentiality, access removal, disaster recovery and vendor-exit responsibilities.
Record applicable retention decisions, review triggers and authority for eventual disposition.

Control later retention decisions

Obtain receiving-custodian acceptance and retain evidence of retrieval testing. Keep changes of storage location and ownership traceable after close-out. Before destruction or irreversible migration, reassess holds, applicable obligations and the ability to preserve the records' meaning and attribution.

Frequently asked questions

Is a system backup an adequate archive?: Only if the actual arrangement meets the applicable accessibility, integrity and retention needs; do not assume equivalence.
Can a departing employee retain the only archive password?: No. Establish authorized institutional continuity and test retrieval before access changes.