Procedure for research projects involving radiation sources or therapeutic products capable of emitting ionising radiation

Depending on the research plan, there are specific rules governing the approval process and execution of research projects involving radiation sources or therapeutic products capable of emitting ionising radiation.

Different procedures depending on the type of research project

Depending on the type of research project, the therapeutic product to be investigated and/or the accompanying inquiries, different rules apply to the submission of applications and approval processes. The requirements applicable to a specific research project can be found using the following filters.

Does the research project involve a clinical trial?

Is the study investigating a therapeutic product capable of emitting ionising radiation?

Is the research project subject to Art. 19 para 2 of the Human Research Ordinance (HRO)?

Is the therapeutic product a medicinal product or a medical device?

Is the clinical trial subject to Art. 28 para 2 of the Clinical Trials Ordinance (ClinO)?

What category does the clinical trial involving medicinal products fall into?

What category does the clinical trial involving medical devices fall into?

Approved medicinal product (Category A)

Download (572708)

Medicinal product used outside scope of approval (Category B)

Download (592029)

Unapproved medicinal product (Category C)

Download (604876)

Medicinal device with CE certification (Category A)

Download (564112)

Medicinal device used outside scope of CE certification or uncertified medicinal device (Category C)

Download (603185)

Trials, in which Art. 28 para. 2 ClinO is not applicable

Download (587166)

Trials, in which Art. 28 para. 2 ClinO is applicable

Download (593016)

Projects, in which Art. 19 para. 2 HRO is not applicable

Download (590804)

Projects, in which Art. 19 para. 2 HRO is applicable

Download (594918)