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.

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

• This is an abbreviated statistical analysis plan (ASAP) designed to outline the planned analysis required to satisfy the Clinical Study Report (CSR) synopsis of study number ADU-CL-14: A Phase 2, Open-label Evaluation of CRS-207 and Pembrolizumab in Adults with Recurrent or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinomas.

• For the other drugs or treatments that must be continued for the complicated diseases, the drug name (orother treatment name), dosage, times of use and time must be recorded on the Clinical Study Report for analysis and reporting during summary.

• However, the data on the proportion achieving transfusion independence, presented in Table 1.7 of the Celgene post- appeal submission, agrees with data presented in Table 11-17 of the Clinical Study Report (Celgene 2007) for the AZA-001 trial which describes red blood cell transfusion status whilst the patient is on-treatment.

• If additional analyses are performed to supplement the planned analyses described in this SAP they will be identified as such in the Clinical Study Report (CSR).

More Definitions of Clinical Study Report

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, means a written description of a Clinical Trial in which all of 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 Study 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 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.

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 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.