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.
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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.
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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.
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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.
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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.
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Related to Study Subject

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be or have been submitted to FDA or other comparable governmental entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, applicable Authorizations, and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and, for studies submitted to regulatory authorities for approval, in all material respects, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete and fairly present the data derived from such studies and trials in all material respects; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes materially call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement or the Prospectus, or the results of which are referred to in the Registration Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMA, Health Canada and other comparable regulatory agencies outside of the U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Registration Statement or the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Development of the Property Except as modified by this Agreement, the Development and the Property will be developed in accordance with all applicable local, state, and federal regulations, including but not limited to the City’s ordinances and the zoning regulations applicable to the Property, and such amendments to City ordinances and regulations that that may be applied to the Development and the Property under Chapter 245, Texas Local Government Code, and good engineering practices (the “Applicable Regulations”). If there is a conflict between the Applicable Regulations and the Development Standards, the Development Standards shall control.