End or temporary halt of a clinical investigation
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Changes
- : Added information about publication of clinical investigation reports and their summaries. The page content has been restructured.
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
Ordinary termination of a clinical investigation
The end of a clinical investigation shall be deemed to coincide with the last visit of the last subject unless another point in time for such end is set out in the clinical investigation plan.
At the ordinary termination 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 EU/EEA (if the investigation is conducted in several member states)
Until Eudamed is available the notification must be submitted by email to kki@noma.no. The email must include the CIV-ID and title of the investigation, as well as NOMAs case reference number.
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 terminated globally.
Temporary halt or early termination
The sponsor must notify NOMA when 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 notification shall be made
- 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 early or temporarily halted on safety grounds
Until Eudamed is available the notification must be submitted by email to kki@noma.no. The email must include the CIV-ID and title of the investigation, as well as NOMAs case reference number.
Clinical investigation report and summary
Content requirements
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. Guidance on the content of the clinical investigation report can be found in the EU Commission’s guidance document Q&A regarding clinical investigations (MDCG 2021-6).
The summary accompanying the clinical investigation report shall be presented in terms that are easily understandable to the intended user. The EU commission has developed guidelines on the content and structure of the summary of the clinical investigation report.
Submission deadline
At the ordinary termination of a clinical investigation the sponsor must submit a clinical investigation report and summary to NOMA no later than 1 year after termination.
In the event of a temporary halt or an early termination of a clinical investigation, the sponsor must submit a clinical investigation report and summary to NOMA no later than 3 months after termination.
Publication of the clinical investigation report and summary
The clinical investigation report and summary must be submitted as two separate documents by email to kki@noma.no.
NOMA will forward the report and the summary to the European Commission, which publishes them on the publicly available directory MDR Clinical Investigation reports and their summaries. This is a temporary solution, until Eudamed is available for this purpose.
The reports and their summaries will be published in the form they are submitted to NOMA. No redaction will be performed by NOMA or the Commission, the sponsor bearing all the responsibility for the content of the documents, including confidentiality and data protection.
More information about the procedures for publication of clinical investigation reports and summaries can be found in the document MDCG 2024-15 Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED.