Ancillary Study definition

Ancillary Study is any study that derives support from independent funds outside of an Add Health Study.
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Ancillary Study means, (a) with respect to a Monotherapy Licensed Product, (i) any Phase I Clinical Trials, and (ii) any pre-clinical bioequivalence studies or similar studies conducted prior to a Phase I Clinical Trial that in each case (1) are conducted for such Licensed Product in the Field in any jurisdiction and (2) are not, in whole or in part, an expansion study Phase II Clinical Trials, Phase III Clinical Trials, a Pivotal Trial or Clinical Trials conducted after Regulatory Approval of such Licensed Product, or (b) with respect to a Licensed Product that is being studied in combination with a chemotherapy product, whether or not in fixed dosage form, any pharmacokinetic studies or bioequivalence studies or dose escalation studies of the Licensed Product from a Phase I Clinical Trial that is not in whole or in part an expansion study, Phase II Clinical Trial, Phase III Clinical Trial, Pivotal Trial, or Clinical Trial conducted after Regulatory Approval of such Licensed Product.
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Examples of Ancillary Study in a sentence

  • Ancillary Study Manuscripts An Ancillary study derives funding from other than MESA contract funds.

  • The Add Health team makes the concluding decision about the final release date of the Ancillary Study datasets.

  • For work that includes analysis of data and/or specimens from HPTN studies that extends beyond planned protocol assessments and study objectives, the HPTN LC and SDMC will obtain approval from the relevant Protocol Chair(s); in these cases, Ancillary Study approval may be required.HPTN LC and SDMC manuscripts that use data and/or specimens from HPTN studies will be submitted to the MRC prior to journal submission.

  • Note: As of November 2010, analysis-only grants involving no such additional CC services require the submission of a Manuscript Proposal form, but not an Ancillary Study Proposal Form.

  • Ancillary Study proposals are circulated to the Steering Committee for approval and coauthor nominations usually include investigators with special expertise and/or interest in the proposal topic.

  • The estimate shall be sufficiently detailed to enable review, by the TOWN and BRS, of all site and building components and systems.

  • Upon early termination of this Agreement, the Ancillary Study Institution shall return all Confidential Information (as defined in Section 12), Materials, and any Add Health Data in its possession at the time of termination to UNC-Chapel Hill.

  • Has a faculty appointment or research position at Ancillary Study Institution or UNC-Chapel Hill, as applicable.

  • Such report shall be made to the contact noted in this Agreement as soon as reasonably possible, but, in any event, no later than five (5) business days from the date on which Ancillary Study Institution becomes aware that the Data have been used or disclosed in a manner not provided for by this Agreement.

  • When the Ancillary Study data are shared to the Add Health staff, the Ancillary Study Investigator must provide Add Health with the preliminary documentation for the additional variables.

Related to Ancillary Study

  • Ancillary state means any state other than a domiciliary state.

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • Interconnection Studies means the Interconnection Feasibility Study, the System Impact Study, and the Facilities Study described in Tariff, Part IV and Tariff, Part VI.

  • Research Budget has the meaning set forth in Section 2.2.

  • Ancillary service means a supplemental service that supports the diagnosis or treatment of the patient’s condition. Examples include diagnostic testing or screening services and rehabilitative services such as physical or occupational therapy.

  • Ancillary Services means those services that are necessary to support the transmission of capacity and energy from resources to loads while maintaining reliable operation of the Transmission Provider’s Transmission System in accordance with Good Utility Practice.

  • Buyer Ancillary Agreements means all agreements, instruments and documents being or to be executed and delivered by Buyer under this Agreement or in connection herewith.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Interconnection Study means any of the studies defined in the CAISO Tariff or, if applicable, any distribution provider’s tariff that reflect the methodology and costs to interconnect the Project to the Participating Transmission Owner’s electric grid.

  • Collaborative pharmacy practice agreement means a written and signed

  • Power production activities means any business operation that involves a project commissioned by the government of Iran whose purpose is to facilitate power generation and delivery, including, but not limited to, establishing power-generating plants or hydroelectric dams, selling or installing components for the project, providing service contracts related to the installation or maintenance of the project, as well as facilitating such activities, including by providing supplies or services in support of such activities.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

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

  • Ancillary Assets means sovereign debt in the currency of denomination of the ETP Securities with an original maturity of less than one month which is rated at least A-1 by Standard & Poor's Ratings Services, and/or P-1 by Moody's Investors Service Ltd. and/or F1 by Fitch Ratings Limited.

  • 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.

  • Development Plan has the meaning set forth in Section 3.2.

  • 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 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).

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • 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.

  • Seller Ancillary Agreements means all agreements, instruments and documents being or to be executed and delivered by Seller under this Agreement or in connection herewith.

  • 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 1 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Regulatory Services Agreement means the agreement between BSEF and the Regulatory Services Provider whereby the Regulatory Services Provider provides market surveillance and trade practice surveillance functions as well as other compliance related services to the SEF operated by BSEF.

  • Phase 1 Trial means, with respect to a Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).

  • Ancillary Agreement has the meaning set forth in the Separation Agreement.