Clinical Research and GCP Update

Site Suitability Template. V 0.3 (endorsed on October 9, 2019)

• Simple self-certification! • Not a mandatory form • No guidance here on who is a suitable signatory. • Information required to assess the suitability of the sites and facilities will vary between different Member States. • Due to varying national legislation and policy which applies in different Member States. • Some Member States will require a signed declaration only, some Member States will require additional information!

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Recruitment and Informed consent procedure template V3 Nov 2019

• It is not mandatory to use this template. • The appropriateness of how subjects will be recruited into the trial and arrangements for obtaining informed consent should be assessed under the Part II assessment, as per Article 7 of the Regulation “Prior Interviews” (Whereas 30; Article 29.2.c), only how long subjects are given to decide. • Nothing explicit on consent

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© Brookwood Global (Canary Ltd) 2021

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