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Early termination is a participant, evidence and disclosure decision; closing a project budget does not complete it.
CTIS early termination — Define the regulatory scope
CTR Articles 37 and 38 address early termination and its reasons. Classify whether the decision relates to a change in benefit-risk before selecting the notification workflow.
CTIS early termination — Build the working record
Prepare a termination package with decision date, medical rationale, follow-up arrangements, site communication, product disposition and outstanding data. Assign ownership for results preparation even when recruitment never reached its target.
CTIS early termination — Check before release
- Reconcile termination scope across countries.
- Document participant information and follow-up.
- Preserve the analysis and disclosure responsibilities.
CTIS early termination — Record the decision and handover
Record what remains open after the official notification. Sponsor approval should cover safety follow-up, data access and the evidence retained for interpreting incomplete results, not only the final site visit.
Frequently asked questions
- Does early termination eliminate results reporting?
- Do not assume so. Assess the applicable results obligations and explain incomplete data.
- Can business reasons and safety reasons be combined?
- Record each accurately and determine the route from the substantive facts.