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A restart plan must explain why activity stopped, what changed and which authorisation or notification route now applies.
CTIS temporary halt and restart — Define the regulatory scope
CTR Articles 37 and 38 distinguish temporary halts by their relationship to the benefit-risk balance. A safety-related restart is treated as a substantial modification.
CTIS temporary halt and restart — Build the working record
Create a halt record describing scope, effective date, participant follow-up, safety assessment and restart conditions. Include sites, product accountability and data collection so that paused recruitment does not obscure ongoing duties.
CTIS temporary halt and restart — Check before release
- Identify the reason and geographical scope.
- Confirm participant care during the pause.
- Document evidence that restart conditions are met.
CTIS temporary halt and restart — Record the decision and handover
Have medical and regulatory owners approve the restart rationale. Verify the applicable authorisation or notification requirements before communicating a site restart; operational readiness alone is insufficient.
Frequently asked questions
- Does a halt stop all participant follow-up?
- Not necessarily. Define continued care and safety activities in the halt plan.
- Are all restarts handled identically?
- No. The reason for the halt determines the applicable CTR route.