Clinical Study Report definition

Clinical Study Report means a description and analysis of the results of a controlled clinical trial with respect to a product that meets the description in the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Guideline E3, Structure and Content of Clinical Study Reports (ICH E3) (including all additions, supplements, and modifications thereto), or provides a reasonable rationale for not addressing all aspects of ICH E3 that are relevant for a given study.

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Clinical Study Report means a report on the clinical trial presented in an easily searchable format, prepared in accordance with Annex I, Part I, Module 5 of Directive 2001/83/EC and accompanying an application for marketing authorisation.

Clinical Study Report means the final clinical study report generated in connection with a Clinical Trial containing all Information generated by the Clinical Trial, cleaned and statistically analyzed.

Examples of Clinical Study Report in a sentence

• Moreover, if publication of the Clinical Trial to the peer reviewed literature has not occurred within twelve (12) months of Clinical Trial completion, ▇▇▇▇▇▇▇ or its designee may post the results of the Clinical Trial to a clinical trial results web site in the form of a Clinical Study Report Synopsis in ICH-E-3 format, if applicable.

• Moreover, if publication of the Clinical Trial to the peer reviewed literature has not occurred within twelve (12) months of Clinical Trial completion, Janssen or its designee may post the results of the Clinical Trial to a clinical trial results web site in the form of a Clinical Study Report Synopsis in ICH-E-3 format, if applicable.

• Moreover, if publication of the Clinical Trial to the peer reviewed literature has not occurred within 18 months of Trial completion, Sponsor may post the results of the Clinical Trial to a clinical trial results web site in the form of a Clinical Study Report Synopsis in ICH-E-3 format, if applicable.

• On a Product-by-Product basis, no later than [***] months before the anticipated Completion of the Phase 2 Dose-Ranging Trial, the Parties shall define and agree on the format and substantive content of the Draft Study Report and the Final Study Report in accordance with the ICH E3 industry guidelines for Structure and Content of Clinical Study Report.

• The remaining * (as may be adjusted up or down based upon actual costs as determined by JMC) shall be paid within thirty (30) days of the receipt by Fujisawa of a Final Clinical Study Report meeting the guidelines of the ICH (International Conference on Harmonization).

More Definitions of Clinical Study Report

Clinical Study Report in accordance with ICH E6 Section 1.13, is a written description of a Clinical Trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report. The Clinical Study Report contains information on results including reactogenicity, adverse events, immunogenicity and other clinical or laboratory observations made with respect to the intervention employed in conducting the trial. A detailed description of the contents of a Clinical Trial Report is found in ICH E3 “Structure and Content of Clinical Study Reports.”

Clinical Study Report has the meaning set forth in Section 3.8.1.

Clinical Study Report means a report on the clinical trial presented in an easily searchable format, prepared in

Clinical Study Report means a clinical study report, or other equivalent document or series of materials, constituting a summary report of the clinical and medical data resulting from a Clinical Study and prepared for incorporation into filings or submissions seeking Regulatory Approval for a Product, and includes all statistical analyses as per the statistical analysis plan at interim analysis and final analysis.

Clinical Study Report means the document in which results of the Research are compiled, as specified in Article 24, paragraph (2) of the Ordinance.

Clinical Study Report means an “integrated” full report of an individual study of SPR206 that includes statistical descriptions, presentations and analyses, 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, prepared under the guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Clinical Study Report means a clinical study report consistent with the guidelines for a clinical study report set forth by the International Council for Harmonization that is submitted to the FDA to support further clinical research or Regulatory Approval.