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    • Recruiting and informing the potential subject.
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    • New template Subject Information Sheet is mandatory from November 2020.
    • CCMO will be the competent authority for clinical investigations with medical devices
    • Modified procedure for submitting local feasibility declaration
    • What is the impact of the GDPR on the informed consent letter?
    • Conditions for (re)starting clinical research in healthcare institutions and CRUs aligned
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New template Subject Information Sheet is mandatory from November 2020.

The CCMO has published a new template Subject Information Sheet for research subjects of 16 years and older (adults).
Researchers are encouraged to use this new template. The template will be used as criterion for the review of the submitted written information for participants. This means that both the structure of the information as well as the wording will be compared to the template informed consent.
More information can be found on the website of the CCMO: link. 

English translation

An English translation of the template is available, but can be used for information purposes only. A Dutch version has to be submitted to the review committee.
More information can be found on the website of the CCMO: link
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