End or temporary halt of a clinical investigation
Published:
Changes
Sponsors’ obligations at the end of a clinical investigation or in the event of a temporary halt or early termination are described in MDR Article 77. The requirements apply to investigations that require application or notification to NOMA.
Page contents
Early termination or temporary halt of a clinical investigation
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 EU commission has developed guidelines on the content and structure of the summary of the clinical investigation report. The summary and the report may be published by the EU Commission.
Ordinary termination of a clinical investigation
At the end of a clinical investigation, the sponsor shall notify NOMA
- no later than 15 days after termination in Norway.
- no later than 15 days after termination in an EU/EEA member state (if the investigation is conducted in several member states).
If the clinical investigation is conducted outside of the EU/EEA in addition to Norway, the sponsor is encouraged to notify NOMA when the investigation is ended globally.
The sponsor must submit a clinical investigation report and a summary to NOMA no later than 1 year after termination.
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 EU commission has developed guidelines on the content and structure of the summary of the clinical investigation report. The summary and the report may be published by the EU Commission.