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Adding a site is a controlled expansion of an existing study. A recruitment shortfall may explain the decision, but it does not establish the new site's readiness or complete the applicable regulatory steps.
Define the proposed addition
Consult the current TİTCK and ethics application guidance for the site's submission requirements. Separate the proposed investigator and institution from an already authorized site. A familiar hospital name or a sponsor feasibility approval cannot substitute for the study-specific documentation and decisions.
Create a site-specific evidence pack
Our recommended evidence pack joins investigator qualifications, local facilities, contract status, insurance impact, consent contact details and pharmacy arrangements. Record dependencies against the proposed activation date. If a service is delivered by another institution, identify the operational interface and the documents needed to explain it.
Release only after reconciliation
- Verify the institution, investigator and address against every site-specific document.
- Reconcile the proposed participant allocation with insurance, budget and product supply.
- Confirm applicable decisions, signed agreements and current approved participant materials.
- Document a named release decision after pharmacy, laboratory and emergency-care checks.
Check the first participant pathway
Walk the first participant's visit through scheduling, consent, eligibility confirmation, product receipt and safety contact. Close unresolved gaps before recruitment release. Preserve the addition history so subsequent reports distinguish the new site's authorization date from its first enrollment date.
Frequently asked questions
- Does sponsor selection activate the site?
- No. Selection is an internal milestone; applicable decisions and operational readiness still need reconciliation.
- Must the new site use the same consent contact details?
- Study information may be shared, but local investigator and participant contact details need site-specific verification.