Study Completion means the database for the Study has been locked and all Essential Documents have been provided to the Sponsor, including a copy of the letter from the Reviewing HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator.
Study means the investigation to be conducted in accordance with the Protocol.
Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).
Study Subject an individual who participates in the Study, either as a recipient of the Investigational Product (defined below) or as a control. Subjekt studie: jednotlivec, který se účastní Studie, buď jakožto příjemce Hodnoceného léčiva (ve smyslu níže uvedené definice) nebo jako kontrolní subjekt.
Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).