Registration Study definition

Registration Study means a Clinical Trial that is intended (as of the time the Clinical Trial is initiated) to obtain sufficient data and results to support the filing of an application for Regulatory Approval (but may not include the data that may be necessary to support the pricing and/or reimbursement approvals).
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Registration Study means a human clinical trial, the principal purpose of which is to establish safety and efficacy in patients with the disease being studied, as further described in 21 C.F.R. §312.21(c) (including, any such clinical study in any country other than the United States), which is designed and intended to be of a size and statistical power sufficient to serve as a pivotal study to support the filing of an MAA for the indication being studied.
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Registration Study means any Clinical Trial of a Licensed Product for which [***].
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Examples of Registration Study in a sentence

  • The Contractor shall coordinate his work with the following Campus Calendar, and No Utility shutdowns will be permitted during Registration, Study Periods, Exam Periods, or Commencement.

  • Age-specific Incidence and Prevalence of Keratoconus: A Nationwide Registration Study.

  • Thrombolysis with 0.6 mg/kg intravenous alteplase for acute ischemic stroke in routine clinical practice: the Japan post-Marketing Alteplase Registration Study (J-MARS).

  • Services include: Admissions, Registration, Study Abroad, Student Finance, Research/Taught Examinations, Student/Graduate Records.– Information about services: www.tcd.ie/academicregistry– Opening hours: Mon, Wed, Fri 9:30-­‐17:00; Tue, Thu 9:30-­‐18:00– T +353 1 896 4500 / E academic.registry@tcd.ieOffice of the Dean of Graduate Studies (www.tcd.ie/Graduate_Studies)– The Dean of Graduate Studies, Prof.

  • US Registration Study OncologyA Phase III randomized study using Xilonix™ was started in March 2013 (IND #114,759).


More Definitions of Registration Study

Registration Study means a Phase 2/3 Clinical Study or Phase 3 Clinical Study. For purposes of Section 7.2, if a Clinical Study becomes a Phase 2/3 Clinical Study after the dosing of the fifth (5th) patient, the applicable Milestone Event shall be deemed to occur on the date that the Party conducting such Clinical Study receives the evidence described in clause (b) of the definition of Phase 2/3 Clinical Study from the applicable Regulatory Authority or, if earlier, on filing of a Drug Approval Application based on the results of such Clinical Study.
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Registration Study means a Clinical Study in humans that is intended to obtain the data sufficient to support the filing of an NDA for a product with any applicable Regulatory Authority. Registration Studies include any Clinical Studies designed as a pivotal study to confirm with statistical significance the efficacy and safety of a product with respect to a given indication (whether structured as a superiority, equivalence or non-inferiority study), which study is performed for purposes of filing an NDA to obtain Regulatory Approval for such product or such indication from the applicable Regulatory Authority (regardless of whether such Clinical Study is identified as a Phase 3 Clinical Study on XxxxxxxxXxxxxx.xxx), including a Clinical Study as described under 21 C.F.R. §312.21(c) with respect to the United States (or, with respect to a jurisdiction other than the United States, a similar Clinical Study).
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Registration Study means a Clinical Trial of a Licensed Product which is sufficiently powered to demonstrate the efficacy and safety of such Licensed Product for purposes of obtaining a Product Approval of such Licensed Product in the U.S. or EU.
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Registration Study means (i) a Phase III Clinical Trial or (ii) any other human clinical trial of a Licensed Product or Lilly Product that is intended to support the submission of a Regulatory Application without conduct of any subsequent Phase I Clinical Trial, Phase II Clinical Trial, or Phase III Clinical Trial.
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Registration Study means the trial is intended to obtain sufficient data to support an application for regulatory approval. The target population for this study represents a subgroup of patients from our completed Phase 3 trial who showed the most survival benefit from Multikine and who can be selected prior to surgery, when Multikine is given. In the prior study, those patients saw their 5-year death rate cut in half vs control.
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Registration Study means a Pivotal Clinical Trial or a Converted Clinical Trial.
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Registration Study means a clinical study that would satisfy the requirements of 21 C.F.R. § 312.21(c) (or analogous statutory requirements outside of the United States).
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