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- Published
- Updated
- Sources checked
An RFI response is strongest when every authority question connects to an answer, an amended document and a submission check.
CTIS RFI responses — Define the regulatory scope
The CTIS handbook describes requests for information during assessment. Treat the deadline shown in the relevant task as a controlled project constraint.
CTIS RFI responses — Build the working record
Create one row per question with the exact concern, scientific owner, answer, supporting evidence and changed pages. Separate drafting, sponsor approval and portal submission so that none is mistaken for completion.
CTIS RFI responses — Check before release
- Check every question has an explicit answer.
- Reconcile clean and tracked document versions.
- Verify submission evidence before closing the task.
CTIS RFI responses — Record the decision and handover
If a response changes eligibility or procedures, assess every affected country document. Escalate missing evidence early and preserve the submitted response package with its timestamp.
Frequently asked questions
- Is an internal approval enough to close an RFI?
- No. Verify the required response was submitted through the applicable CTIS task.
- Should repeated questions be merged?
- They may share evidence, but retain a visible answer and traceability for each question.