End or temporary halt of a performance study
Published:
Changes
The sponsor’s obligations at the end of a performance study, or in the event of a temporary halt or early termination, are outlined in Article 73 of the IVDR. The requirements apply to studies subject to an application or a notification.
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Early termination or temporary halt of a performance study
NOMA must be notified 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 sponsor must notify NOMA
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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 or temporarily halted on safety grounds.
The sponsor must submit a performance study report accompanied by a summary to NOMA no later than 3 months after termination. This also applies in the event of a temporary halt unless the performance study is recommenced within the 3 months. In this case, the report should be sent to NOMA when the performance study is completed. The report must contain information about the temporary halt.
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. The summary and the report will be made publicly accessible. Arrangements for publication in the absence of Eudamed will be made.
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:
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no later than 15 days after termination in Norway.
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no later than 15 days after termination in an EU/EEA member state (if the study is conducted in several Member States).
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.
The sponsor must submit a performance study report and a summary to NOMA no later than 1 year after termination.
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. The summary and the report will be made publicly accessible. Arrangements for publication in the absence of Eudamed will be made.