Clinical Study Report definition

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 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.

Clinical Study Report means, with respect to a Clinical Trial, a report containing the results of such Clinical Trial that is consistent in content and format with Applicable Laws and Regulations and with the guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) on Structure and Content of Clinical Study Reports.

Examples of Clinical Study Report in a sentence

• Clinical study report structure, contents and format for clinical study report.

• Clinical study report for the product under application (applications for nutritionally complete food with balanced formula is exempted from the requirement)Documents in languages other than English and Chinese must be accompanied with English or Chinese translations provided by a registered translation agency.Permit documents issued on the extension applications specified in Paragraph 1 and filed and reviewed pursuant to the Regulations shall be valid for five years.

• Clinical study report for protocol P 09-09 Efficacy and safety of BF2.649 in the treatment of Excessive Daytime Sleepiness in patients with Obstructive Sleep Apnoea syndrome (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy – Phase III EudraCT N°: 2009-017251-94, 2019.

• Clinical study report for study CA037 will be completed in QII 2008.The SPC for Abraxane, Section 4.2 includes the following statement:‘Insufficient data are currently available to recommend dose modifications in patients with mild to moderate hepatic impairment (see sections 4.4. and 5.2).

• Clinical study report: Daratumumab (HuMax-CD38) Safety Study in Multiple Myeloma – Open-label, Dose-Escalation Followed by Open-Label, Single- Arm Study.

More Definitions of Clinical Study Report

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.

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

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.” [COMMENT: The Clinical Study Report may be a publication reporting the results of the Clinical Trial.]

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

Clinical Study Report means the document in which results of the Research are compiled.

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.