Clinical Trial Report definition

Clinical Trial Report means, with respect to a human clinical study of a Product, the final study report from such clinical study.
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Clinical Trial Report means a report of a clinical study of any Lead Molecule or Product where the clinical and statistical description, presentations, and analyses are integrated into a single report, incorporating tables and figures into the main text of the report or at the end of the text, with appendices containing such information as the protocol, sample case report forms, investigator-related information, information related to the test drugs/investigational products including active control/comparators, technical statistical documentation, related publications, patient data listings, and technical statistical details such as derivations, computations, analyses, and computer output.
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Clinical Trial Report means a written description of a clinical
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Examples of Clinical Trial Report in a sentence

  • In addition, with respect to each Phase II Clinical Trial completed for any Product during the ROFN Period, as promptly as practicable following completion of such Clinical Trial, RBNC shall prepare and deliver to Amgen the Clinical Trial Report with respect to such Phase II Clinical Trial.

  • The Parties shall work together to ensure such Monthly Clinical Trial Report is in a form acceptable to Avro.

  • UHN and/or UHN CRO shall provide such Monthly Clinical Trial Report to Avro within [***] after the end of each calendar month.

  • For purposes of the immediately preceding sentence, beneficial ownership shall be determined in accordance with Section 13 (d) of the Securities Exchange Act of 1934, as amended, and Regulation 13 D-G thereunder, except as otherwise provided in clause (1) of the immediately preceding sentence.

  • OV shall provide R-Pharm with (a) an electronic draft of the final clinical study report and the tables and listings (“mBC Clinical Trial Report”) for R-Pharm to provide comments to OV (which comments shall be provided within forty-five (45) days of receipt of the draft of the mBC Clinical Trial Report) and (b) a final version of the mBC Clinical Trial Report, in each case as soon as reasonably practicable following mBC Clinical Trial Completion.

  • OV shall consider in good faith any comments provided by R-Pharm on the mBC Clinical Trial Report and shall not include any statements relating to the Product which have not been approved by R-Pharm.

  • These data will be reported separately in a Clinical Trial Report Addendum.

  • Table 5: Disposition of Postmenopausal Women in Trial ERC-231 Disposition Source: Adapted from Statistical Review Table 2, page 9, Medical Officer Review Table 6, page 54, and NDA 208470, Trial ERC-231 Clinical Trial Report, Figure 8-1, page 66 of 591.

  • The results will be reported either as an amendment to the Clinical Trial Report or in a separate Clinical Trial Report.

  • China only: The Clinical Study Report will be compliant with the elements from the NMPA 2016 No. 58 Announcement Annex 5 “Template of Clinical Trial Report of Medical Devices”.

Related to Clinical Trial Report

  • 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.

  • Clinical Trial means any human clinical trial of a Product.

  • 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.

  • 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.

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

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • 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: