Subject consent and enrolment into the Study Sample Clauses

Subject consent and enrolment into the Study. As well as complying with the requirements of GCP and other legislation appropriate to clinical trials, medical treatment, and the processing of personal and medical data, the Institution shall procure that the Principal Investigator shall, before entering a patient into the Study: 3.6 Souhlas Subjektu a zařazení do Studie. Kromě splnění požadavků GCP a dalších právních předpisů příslušných pro klinická hodnocení, zdravotní péči a zpracování osobních a zdravotních údajů Instituce zajistí, aby Hlavní zkoušející před zařazením pacienta do Studie: 3.6.1 exercise independent medical judgement as to the compatibility of each prospective Subject with the requirements of the Protocol; 3. 6.1 provedl nezávislý lékařský úsudek, zda každý potenciální Subjekt splňuje požadavky Protokolu; 3.6.2 advise the Sponsor of all instances in which, in the Principal Investigator’s judgement, there is any question as to any prospective Subject’s suitability for participation in the Study, and abide by the Sponsor’s decision as to whether or not to enrol that Subject into the Study; 3
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