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Quiz: Select the right reviewing committee
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Question 1 of 2
1. Question
1 A phase I study with a non-licensed cellular product
A physician-investigator at a Dutch university medical center is planning a phase I clinical study using a non-licensed cellular product in adult patients with melanoma. Specifically, the patients’ immune cells will be isolated and cultured ex vivo with specific cytokines in order to drive differentiation of the cells. The cells will then be incubated with synthetic peptides derived from tumor-specific proteins, and subsequently returned to the patient.
To which review body or bodies must the research file be submitted? (use the Committee Finder tool; for your conveniences it will open in a separate tab in your browser)
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Question 2 of 2
2. Question
2. A clinical study with a new device with CE marking
A company is planning a clinical study to investigate a new medical device using adult patients with high blood pressure who do not respond to standard medications. For the device the company has obtained CE marking (Conformité Européene; in English: European Conformity) for the indication that is investigated in the clinical study.
Which body or bodies must approve this clinical study? (use the Committee Finder tool; for your conveniences it will open in a separate tab in your browser)
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