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Pausing recruitment does not necessarily stop treatment or follow-up. Türkiye study teams need a precise scope statement so sites understand which activities cease and which participant responsibilities continue.
Define the reason and scope
Review the current TİTCK application and safety guidance for the circumstances and any applicable notification or decision requirements. Distinguish a recruitment pause from suspension of dosing, a supply interruption and early termination. The label in a project email cannot replace that assessment.
Create a controlled pause instruction
We recommend a pause instruction that states affected countries, sites, participant groups, activities and effective time. Include the medical contact and instructions for people already screened or scheduled. Preserve the reason and decision authority; avoid circulating different informal explanations through clinical, pharmacy and recruitment channels.
Check continuity at each site
- Identify screening, enrollment, dosing and follow-up activities separately.
- Protect ongoing participant care and confirm how urgent safety questions are handled.
- Reconcile site receipt, recruitment notices, product supply and public status information.
- List restart evidence, required decisions and a named authority to release the pause.
Set explicit restart conditions
Before restart, check whether the cause has been resolved and whether protocol, consent, training or supply changes are needed. Document site acknowledgement of the released instruction. A recovered recruitment target is not sufficient evidence that the underlying medical or quality concern is closed.
Frequently asked questions
- Does recruitment halt mean every visit stops?
- No. Define the affected activities and maintain clinically appropriate follow-up and safety arrangements.
- Who may announce restart?
- Use the assigned sponsor authority after applicable requirements and documented restart conditions have been satisfied.