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Last participant last visit, site close-out and a regulatory completion notice are different milestones. Treating them as one date can obscure unfinished safety follow-up or product reconciliation in a Türkiye study.
Define each closing milestone
TİTCK provides completion notification information and separate product closure resources. Use the applicable current guidance to establish each submission and its triggering event. Avoid a universal deadline calculated from a convenient database date; the relevant event and reporting requirement need explicit confirmation.
Create a closure dependency map
Our recommended dependency map links participant care, data queries, site close-out, product accountability, submission records and archive transfer. Each stream has its own owner and completion evidence. A site may stop recruitment while still caring for participants, and a finished visit schedule may leave unresolved safety information.
Check the final handover
- Agree the protocol-defined completion event and reconcile country and global milestones.
- Confirm outstanding participant follow-up, queries and safety reconciliation responsibilities.
- Reconcile received, used, returned and destroyed product before the closure package is finalized.
- Archive applicable notifications, receipts and signed handover records with the study file.
Keep residual obligations visible
A closure meeting should leave a short residual-obligations register, not merely a green dashboard. Identify who answers later authority questions, maintains contact details and retrieves records. Retain evidence that receiving archive and safety teams have accepted their ongoing duties.
Frequently asked questions
- Does site close-out end all sponsor responsibilities?
- No. Reporting, follow-up and record responsibilities may remain after the operational visit.
- Can product closure be inferred from zero stock?
- No. Reconcile the full quantity history and the applicable closure documentation.