Spring Intro 2023

24/03/2023

• Subjects receive inferior treatment than national normal clinical practice • National law restricts the examination e.g., of abortion or the use of fetal cells • Objection concerning the safety or reliability of subjects for data presented by the Member State concerned has not been considered by the rapporteur Member State • Negative opinion issued by the National Ethics Committee The reportingMember State's conclusionmust in principlebe fo l owed, but if it is concluded that theclinical trial is acceptablewithor without conditions, thedecision neednot be fo l owed if:

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Supervision - Corrective actions

• Member State concerned may: o Revoke the state of the clinical trial

o Issue a temporary ban on continuing the clinical trial o Require the sponsor to change any aspect of the clinical trial • The sponsor / investigator must be given the opportunity to comment (7 days) except if immediate action is required • Other MSCs must be notified via the EU portal, consultation with these can be carried out before action is taken (CTIS function ad-hoc assessment)

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