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A fast reply can create a second query if the revised protocol, consent and cover letter tell different stories. Türkiye study teams should manage each authority or ethics question as an evidence-linked decision.
Separate the questions and recipients
Use current TİTCK and ethics application guidance for the relevant response route and document requirements. Keep each recipient's questions and decision history distinct. A clarification accepted by one reviewer does not automatically resolve another reviewer's concern or authorize an unrelated study change.
Build a response matrix
We recommend a matrix with the original question, response owner, proposed answer, supporting document location and downstream impacts. Preserve the question's wording for accurate handling within the study team. Have scientific answers reviewed by the responsible expert rather than asking the submission coordinator to infer a clinical justification.
Check the complete revised package
- Break compound questions into accountable actions without losing the reviewer's original context.
- Link every promised change to a clean document, redline and controlled version.
- Check whether the answer affects other recipients, sites, systems or participant materials.
- Reconcile the cover letter, attachment list and final signed submission before dispatch.
Freeze the submitted answer
Freeze the submitted matrix with its evidence and receipt. Record later clarification as a new step instead of editing the historical answer. If the team cannot support an assertion, explain the limitation and proposed resolution rather than presenting an assumption as established fact.
Frequently asked questions
- Can the cover letter contain the whole correction?
- It can explain it, but affected controlled documents must also be reconciled.
- Should every reviewer receive exactly the same reply?
- Use consistent scientific facts while addressing each recipient's actual questions and applicable submission requirements.