Trial visit definition

Trial visit means a patient privilege of a longer stated duration of unsupervised community contact with an expectation of return to the hospital or institution at designated times.
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Trial visit means a patient privilege of a longer 49
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Trial visit means a patient privilege of a longer 45
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Examples of Trial visit in a sentence

  • At the first Trial visit after the washout period, the Trial Subject will complete the C1D1 assessment schedule except for the following tests, which are not required: ECG, PK blood sample and biomarker plasma sample.

  • CRO shall send quarterly overviews to the Institution, setting out the amounts earned by the Institution, based on the Trial visit s and Trial procedures completed and the Trial Data reported in compliance with this Agreement (each a “ Quarterly Overview ” ).

  • Study Visits‌Participants in the Bone Trial will follow the established T Trial visit schedule.

  • Agreed reimbursements for travel and other expenses for Trial subjects included in the Trial will be invoiced retroactively based on the patients' participation in the individual parts of the Trial visit to the Institution and on the basis of documents sent by the Trial monitor and approved by the Principal Investigator.

  • Employment services providers are located across Australia, and their contact details are available at jobactive.gov.au/serviceproviders.For more information on horticultural work and the Seasonal Work Incentives Trial visit jobs.gov.au/seasonal- work-incentives-trial.Council’s Current Works ReportinThe following works are scheduled to be undertaken throughout the Latrobe Municipality during May and June.

  • Blood samples for assessment of antibody formation against N8-GP will be drawn at the screening visit, pre-dose of N8-GP administration at all visits (except visit 2b) and at the follow-up visit approximately one month after the End of Trial visit.

  • Patient expenses shall not exceed the following amounts per person per Trial visit without the prior written consent of the Sponsor: ii) Spese ragionevoli di viaggio e sussistenza sostenute dai pazienti e fino a un (1) adulto accompagnatore (genitore/tutore) per presenziare alle visite del Trial.

  • Trial visit schedules will be prepared for each patient at randomisation, and patients should be followed on the same schedule even if their trial medication is discontinued.

  • During the End of Trial visit, subjects will complete the same questionnaires completed during the baseline visit.

  • The PI or delegated research team member should reassess concomitant medications at each Trial visit and record the required medicines on the CRF.


More Definitions of Trial visit

Trial visit means an authorized overnight absence from a state facility without a staff escort for the purpose of assessing an individual's readiness for discharge. Trial visits do not include special hospitalizations, facility-sponsored summer camps, or other facility-sponsored activities that involve staff supervision.
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Trial visit means an approved leave for a youth from an institution in a trial placement, not exceeding 30 days.
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Trial visit means an authorized overnight absence from a state facility without a staff
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Trial visit means an authorized overnight absence from a state facility without a staff escort for
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Related to Trial visit

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.

  • 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).

  • 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 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.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Phase IV Clinical Trial means a post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.

  • Phase II Trial means a clinical trial of a Licensed Product, designated as a Phase II Trial and the principal purpose of which is to make a preliminary determination that such Licensed Product is safe and active in a patient population for its intended use and is designed to obtain sufficient information about such Licensed Product’s efficacy to permit the design of a Phase III Trial(s), and generally consistent with 21 CFR § 312.21(b). For purposes of this definition, Phase II trial shall specifically exclude expansion cohorts from Phase I Trial(s).

  • Milestone Event has the meaning set forth in Section 1.11(a).

  • 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.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Phase 1 Trial means, with respect to a Product, a human clinical trial that is intended to initially evaluate the safety, metabolism and pharmacokinetics of such Product that would otherwise satisfy the requirements of 21 C.F.R. 312.21(a) or an equivalent clinical trial in a country other than the United States.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • 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.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Pivotal Clinical Trial means a Phase 3 Clinical Trial, or a Phase 2b Clinical Trial for which the applicable Regulatory Authority has determined that the data generated in such Phase 2b Clinical Trial would be sufficient, depending on its outcome, to support the Regulatory Approval for the applicable Licensed Product.

  • Treatability study means a study in which a hazardous waste is subjected to a treatment process to determine: (1) Whether the waste is amenable to the treatment process, (2) what pretreatment (if any) is required, (3) the optimal process conditions needed to achieve the desired treatment, (4) the efficiency of a treatment process for a specific waste or wastes, or (5) the characteristics and volumes of residuals from a particular treatment process. Also included in this definition for the purpose of the § 261.4 (e) and (f) exemptions are liner compatibility, corrosion, and other material compatibility studies and toxicological and health effects studies. A “treatability study” is not a means to commercially treat or dispose of hazardous waste.

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • 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 III means human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

  • Phase 1 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations.

  • Milestone Events has the meaning set forth in Section 7.2.

  • 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.

  • 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.

  • Attack directed against any civilian population means a course of conduct involving the multiple commission of acts referred to in paragraph 1 against any civilian population, pursuant to or in furtherance of a State or organizational policy to commit such attack;