Ancillary Study definition

Ancillary Study is any study that derives support from independent funds outside of an Add Health Study.
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.

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.

  • 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.

  • 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.

  • 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.

  • UNC-Chapel Hill may provide Material to Ancillary Study Institution under this Agreement.

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

  • For detailed policies on data cleaning, variable construction, and data release, see Exhibit D - Add Health Policies on the Cleaning and Release of Ancillary Study Data.

  • Researchers are asked to pay an administrative fee to use the facility and must agree that all data appended to Add Health data will become part of the Add Health data sets that are dis- tributed to the research community.Researchers interested in obtaining archivedbiospecimen samples from Add Health, including urine and buccal cell DNA, to conduct additional biospeci- men analysis must submit an Ancillary Study proposal to the Add Health Principal Investigator.

  • We strongly encourage individuals interested in submitting an ancillary study proposal to contact the Ancillary Study Team at addhealth_ancillary@unc.edu well in advance of the submission of a proposal.

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.

  • 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.

  • ancillary works means the ancillary works described in Part 2 of Schedule A (authorised project) [and any other works authorised by the Order] and which are not development within the meaning of section 32 of the 2008 Act;

  • Interconnection Study means any of the studies defined in the CAISO’s Tariff or any Transmission/Distribution Owner’s tariff that reflect methodology and costs to interconnect the Facility to the Transmission/Distribution 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 Xxxxx 0 Xxxxx, Xxxxx 2 Study, Phase 3 Study, Post-Marketing Study, Supplemental Study or other study (including a non-interventional study) in humans to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product.

  • 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.

  • 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 Contracts, instruments and documents being or to be executed and delivered by Seller under this Agreement or in connection herewith.

  • 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.

  • 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.

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

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Ancillary Facilities means all facilities ancillary to the Temporary Casino or the Melbourne Casino identified in the Melbourne Casino Complex Development Proposals or the Temporary Casino Complex Development Proposals (as the case may be) to be constructed on or located within the Temporary Casino Site or the Site, including an hotel, restaurant, retail, recreation, entertainment and carparking facilities, residential and office accommodation, staff facilities, staff carparking, coach storage facilities and open space areas;

  • 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.