Study Subject Clause Samples
The Study Subject clause defines the individual or group participating in a research study, specifying who will be involved as subjects. It typically outlines eligibility criteria, such as age, health status, or other relevant characteristics, and may detail how subjects are selected or excluded. This clause ensures clarity about who the research applies to, helping to maintain ethical standards and the scientific validity of the study by clearly identifying the population under investigation.
POPULAR SAMPLE Copied 1 times
Study Subject. Any qualified participant who meets all the inclusion criteria and none of the exclusion criteria set forth in the Protocol and has signed an ICF. Technical Data. As defined in DFARS 252.227-7013. Technology. Investigational drugs, biologics or medical devices that are regulated by the U.S. Food and Drug Administration (FDA) and require FDA pre-market approval or clearance before commercial marketing may begin.
Study Subject a natural person who has signed an Informed Consent and participates in the Study, either as a recipient of the Study Drug or a member of a reference or control group to whom the Study Drug is not being administered.
Study Subject a natural person who has signed an Informed Consent and participates in the Study, either as a smlouvy a který je dále specifikovaný v Článku 3.
Study Subject. 1) Principal Investigator shall make every effort to perform enrolment, selection and participation of Study Subject in Study in accordance with admission criteria and excluding criteria and schedule as stated in Protocol.
2) Investigator shall stop enrolment in accordance with the instructions of the Sponsor or the CRO when the total number of Study subjects enrolled planned to be included to the Study per the Protocol has been reached among all the sites participating in the (multicenter) Study.
3) The Study Subjects can be enrolled in the Study only following the written Informed Consent being signed and the necessary information being given to them (Study Subjects under age of majority or Study Subjects who are unfit to give informed consent shall be enrolled into the Study only provided that their legal representatives are provided the appropriate information and their consent being obtained). s vykonávaním Klinického skúšnaia bez predchádzajúceho písomného súhlasu Zadavatel‘a alebo CRO. V prípade, že ▇▇▇▇▇▇▇▇▇‘ alebo CRO takýto súhlas udelí, potom akákoľvek zmluva uzatvorená medzi Zdravotníckym zariadením a treťou stranou ako povoleným subdodávateľom musí primerane obsahovať ustanovenie článkov VII, XI, XIII a XIV.tejto Zmluvy.