End or temporary halt of a performance study
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Sponsor’s obligations at the end of a performance study, or in the event of a temporary halt or early termination, are described in IVDR Article 73. The requirements apply to studies that require an application or a notification to NOMA.
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Ordinary termination of a performance study
The end of a performance study 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 performance study plan.
At the end of a performance study 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 study 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 title of the performance study, PS-ID and NOMAs case reference number.
If the performance study is conducted outside of the EU/EEA in addition to Norway, the sponsor is encouraged to notify NOMA when the performance study is ended globally.
Early termination or temporary halt of a performance study
The sponsor must notify NOMA if a performance study 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
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no later than 15 days if the performance study is terminated early or temporarily halted.
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no later than 24 hours if the performance study 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 title of the performance study, PS-ID and NOMAs case reference number.
Performance study report and summary
Content requirements
The performance study report must meet the requirements in section 2.3.3, part A, Annex XIII in IVDR.
The summary accompanying the performance study report shall be presented in terms that are easily understandable to the intended user. This may be health professionals and/or patients.
Submission deadline of the performance study report and summary
At the ordinary termination of a performance study the sponsor must submit a performance study report and a summary to NOMA no later than 1 year after termination.
In the event of a temporary halt or an early termination of a performance study, the sponsor must submit a performance study report accompanied by a summary to NOMA no later than 3 months after termination. If the performance study is recommenced within 3 months of the temporary halt, the report can be sent to NOMA when the performance study is completed. The report must contain information about the temporary halt.
Until Eudamed is available the performance study report and summary must be submitted by email to kki@noma.no. The summary and the report will be made publicly accessible. Arrangements for publication in the absence of Eudamed will be made.