Informed Consent 1. 5 Informovaný souhlas a) The Investigator shall obtain in compliance with all Applicable Regulatory Requirements an EC/IRB approved informed consent properly signed by or on behalf of each Study subject prior to the subject’s participation in the Study. b) The Investigator shall use the form of the informed consent (the “Informed Consent Form”) provided by PSI and approved in compliance with all Applicable Regulatory Requirements.
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Informed Consent 1. 5 Informovaný souhlas
a) The Investigator shall obtain in compliance with all Applicable Regulatory Requirements an EC/IRB approved informed consent properly signed by or on behalf of each Study subject prior to the subject’s participation in the Study.
b) The Investigator shall use the form of the informed consent (the “Informed Consent Form”) provided by PSI and approved in compliance with all Applicable Regulatory Requirements.
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Sources: Clinical Study Agreement