- Published
- Updated
- Sources checked
Start, recruitment and end events can diverge across countries; a single project milestone cannot represent every regulatory notification.
CTIS trial event notifications — Define the regulatory scope
CTR Articles 36 and 37 address trial event notifications. Use the protocol definitions and the applicable event scope when identifying what must be reported.
CTIS trial event notifications — Build the working record
Maintain an event ledger showing country, event type, actual occurrence date, evidence source, notification due date and submission receipt. Reconcile it with site reports and the trial management system.
CTIS trial event notifications — Check before release
- Distinguish trial start from recruitment start.
- Check country end against global end.
- Resolve inconsistent source dates before submission.
CTIS trial event notifications — Record the decision and handover
Assign one accountable reviewer for the event ledger. If an incorrect date was reported, assess the correction workflow and downstream results deadlines rather than silently changing the internal tracker.
Frequently asked questions
- Is last participant last visit always trial end?
- Only if it matches the protocol-defined end and the relevant reporting scope.
- Can an internal CTMS update replace CTIS notification?
- No. Confirm the required official notification separately and retain evidence.