NoMA must be notified if a clinical investigation is terminated early or in the event of a temporary halt. The notification must include a justification for the early termination or temporary halt.
The sponsor must notify NoMA
- no later than 15 days if the clinical investigation is terminated early or temporarily halted.
- no later than 24 hours if the clinical investigation is terminated or temporarily halted on safety grounds.
The sponsor must submit a clinical investigation report and a summary to NoMA no later than 3 months after termination. This also applies in the event of a temporary halt unless the investigation is recommenced within the 3 months. In this case, the report should be sent to NoMA when the clinical investigation is completed. The report must contain information about the temporary halt.
The clinical investigation report must meet the requirements set out in MDR section 2.8 of Chapter I and Section 7 of Chapter III of Annex XV.
The summary accompanying the clinical investigation report shall be presented in terms that are easily understandable to the intended user. This may be health professionals and/or patients. The summary will be published.