Approved study definition

Approved study means a medical research study:
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Approved study means a course or program approved by the Minister, on the recommendation of the Board, pursuant to subsection 3(2);
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Approved study has the meaning set forth in Section 3.5(a).
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Examples of Approved study in a sentence

  • Approved study for an intercalated degree does not constitute interrupted progress.

  • Approved study abroad program of Indiana University in the student’s non-native country will apply toward this requirement.

  • Approved study leave may be pooled and accessed over the period of study.

  • Study protocols with approved (by the JKEUPM) final reports, orb Approved study protocols declared Inactive by the review panel if no communication is received from study team for a period of twelve months.c. Study protocols for initial review with resubmissions beyond 90 days from date of action letter.Upon receipt of JKEUPM FORM 3.2: STUDY FINAL REPORT, the JKEUPM panel reviews it in accordance with SOP III.

  • Approved study assistance up to the full tuition fee will be paid from the relevant cost centre prior to commencement of the course by the staff member.

  • Study protocols with approved (by the JKEUPM) final reports, or b Approved study protocols declared Inactive by the review panel if no communication is received from study team for a period of twelve months.

  • Approved study: graduate or undergraduate courses successfully passed after prior approval by the appropriate Xxxx of Academic Affairs.

  • Approved study abroad program: These programs include only those approved by the UNC-Chapel Hill Study Abroad Office or the UNC-Chapel Hill Honors Program.

  • The UO Foreign Study Programs Committee in collaboration with Study Abroad staff will identify which UO-sponsored programs will meet the International Cultures requirement, based on the following criteria: • Students must be enrolled full-time and maintain satisfactory academic progress throughout their academic programs abroad.• Approved study abroad programs must be a minimum of five weeks in length.

  • Approved study personnel will use this list to identify subjects that fulfill inclusion criteria and are not excluded according to exclusion criteria, and then contact potential subjects to ask if they might be willing to participate in the study.


More Definitions of Approved study

Approved study means a study that the Parties have agreed shall be conducted and jointly funded in accordance with Section 4.6, which comprises (a) each study designated as an Approved Study in the 2007-2009 Clinical Development Plan as of the date of this Amendment No. 2 and (b) each other study that shall be designated as • • an Approved Study in a subsequent Clinical Development Plan in accordance with the procedures set forth in Section 4.3(f), each Proposed Study or Emergency Study that is added to the then-current Clinical Development Plan as an Approved Study in accordance with the provisions of Sections 4.3 (f) or 4.3 (i), as the case may be, and each Contingent Approved Study that shall be designated as an Approved Study in accordance with the provisions of Section 4.3(h).
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Approved study means the data collection, evaluation, analyses and professional services report, with a scope as defined in Exhibit “A”.
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Approved study means the study described in the DAR for which the Data is to be used.
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Approved study means the study described in the CSR for which access is to be provided.
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Related to Approved study

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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 I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • 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.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Approved program or approved State means a State administered NPDES program which has been approved or authorized by EPA under 40 CFR Part 123.

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

  • 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 I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • 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 II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • 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 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.

  • Approved Source means Cisco or a Cisco authorized reseller, distributor or systems integrator.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Feasibility Study means the evaluation and analysis of the potential of a project, which aims at supporting the process of decision-making by objectively and rationally uncovering its strengths and weaknesses, opportunities and threats, as well as identifying the resources required to carry it through and ultimately its prospects for success;

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

  • Phase III Trial means a human Clinical Trial of the Licensed Product, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use; (b) to define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) consistent with 21 CFR § 312.21(c).

  • Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Phase 3 Study means a clinical study of an investigational product in patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in a country other than the United States. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents [***]

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • 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 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.