Clinical Trial Participant definition

Clinical Trial Participant means an individual who is eligible and who has consented or, where applicable, whose legal representative has consented on behalf of the Clinical Trial Participant, to participate in the Clinical Trial;
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Clinical Trial Participant means a person enrolled to participate in the Clinical Trial according to criteria detailed in the Protocol;
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Clinical Trial Participant means an individual participating in a clinical trial and providing Personal Information to third parties Eupraxia has contracted with to conduct the trial.
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Examples of Clinical Trial Participant in a sentence

  • Within 30 days after the termination of this Agreement, Investigator shall deliver to [choose Sponsor or CRO to match contracting party] in writing a final accounting of: all Clinical Trial Participants that participated in the Clinical Trial; the Clinical Trial Participant visits completed in accordance with the Protocol during the Term; and all reasonable direct costs incurred in connection with any transfer of the Clinical Trial to another trial site.

  • Investigator shall ensure that neither administration of the Investigational Product to any Clinical Trial Participant nor any other clinical intervention mandated by the Protocol takes place in relation to any Clinical Trial Participant until all relevant regulatory approvals and an approval from the REB have been obtained, as well as [choose Sponsor or CRO to match contracting party]’s written confirmation of the start date for the Clinical Trial at the Clinical Trial Site.

  • If the Secretary of State refuses to approve the recommended settlement, the Secretary will notify the parties of thedisapproval, and the case will proceed as though no settlement proposal had been made.(c) Scope of settlement.

  • Notwithstanding the above, medically necessary deviations from the Protocol for reasons of Clinical Trial Participant safety shall not nullify or minimize Sponsor’s indemnification obligations, as long as such deviations are consistent with prevailing standards of medical care.

  • Research Participant Concerns Clinical Trial Participant Concerns - CISCRP - Center for Infor ...

  • Any right or remedy of a third party that existed or is available apart from the relevant Third Party Rights Act is not affected; in particular, without limitation, any right of any Clinical Trial Participant to claim compensation in accordance with the Clinical Trial Compensation Guidelines referred to in Appendix 2.

  • Without prejudice to the foregoing if injury is suffered by a Clinical Trial Participant while participating in the Clinical Trial, the Sponsor agrees to operate in good faith the guidelines published in 2015 by The Association of the British Pharmaceutical Industry and entitled “Clinical Trial Compensation Guidelines” and shall request the Principal Investigator, to make clear to the Clinical Trial Participants that the Clinical Trial is being conducted subject to the Association Guidelines.

  • Clinical Trial Participant Concerns - CISCRP - Center for Infor ...

  • In the event of any claim or proceeding in respect of personal injury made or brought against the Trial Site by a Clinical Trial Participant, the Sponsor shall indemnify the Trial Site, its Agents and employees in accordance with the terms of the indemnity set out in Appendix 3 hereto.

  • Clinical Trial Medical Expenses Each Clinical Trial Participant Limit:$<xx,xxx,xxx>Aggregate Limit:$<xx,xxx,xxx>Retention:$<xxx,xxx> FIRST-PARTY COVERAGE 1.


More Definitions of Clinical Trial Participant

Clinical Trial Participant means an individual participating in a clinical trial in the EU and providing personal information to third parties Eupraxia has contracted with to conduct the trial. Clinical Trial Participant has the same meaning as “Data Subject” under Article 4 of the GDPR.
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Related to Clinical Trial Participant

  • Clinical Trial means any human clinical trial of a Product.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Pivotal Trial means a clinical study in humans of the efficacy and safety of a Licensed Product that is prospectively designed to demonstrate with statistical significance that such product is effective and safe for use in a particular indication in a manner sufficient to file for Marketing Approval of such product and would satisfy the requirements of 21 CFR 312.21(c), or a similar clinical study prescribed by the Regulatory Authorities in a country other than the United States.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Program participant means an individual certified by the secretary as a program participant under Iowa Code section 9E.3.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Study Participant means a person recruited to participate in the Study.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Class Year Study means a Class Year Interconnection Facilities Study as that term is defined in OATT Section 25 (OATT Attachment S).

  • Potential Takedown Participant shall have the meaning set forth in Section 3.2.5(b).

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • 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).

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Active Participant means, with respect to any day or date, a Participant who is in Service on such day or date; provided, that a Participant shall cease to be an Active Participant (i) immediately upon a determination by the Committee that the Participant has ceased to be an Employee or Independent Contractor, or (ii) at the end of the Plan Year that the Committee determines the Participant no longer meets the eligibility requirements of the Plan.

  • 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).

  • Drug-dependent person means a person who is using a