clinical study report


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clinical study report

A written description of a study of any therapeutic, prophylactic or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations and analysis are collated in a single report.
References in periodicals archive ?
You can download extensively annotated outlines of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) documents such as a Protocol or Clinical Study Report (CSR).
ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports E3 www.
Document-specific checklists can cover the types of source documents needed, which aids in performing the gap analysis and provides the conventions used throughout the document (for example, using past tense in the methods section of a clinical study report versus future tense in a protocol).
OTC Bulletin Board: RGRX) ("the Company" or "RegeneRx") announced today that it has received the clinical study report for its recently completed Phase 2 clinical trial evaluating RGN-259 for the treatment of dry eye syndrome.
The software saves the narratives as a Rich Text Format (RTF) file for further configuration and inclusion in the Clinical Study Report.
In addition, the company is committed to enhancing Clinical Study Report summaries for all new pivotal studies to include easy to understand consumer language summaries and additional interpretation of data as of the end of 2014.
We ask all candidates to take an assessment consisting of a page of text from a clinical study report, a sample table with an accompanying source table to verify data, and a series of questions regarding editing examples.
Regulatory documents include the study protocol, case report forms, informed consent, investigator's brochure, clinical study report, the IDE, premarket notification or 510(k), the PMA, and product labeling.
Even seasoned medical writers can feel daunted when distilling a lengthy clinical study report (CSR) into a 2,500-word manuscript for submission to a peer-reviewed journal.
Examples of blog post titles include "Importance of Language and Writing Style in a Clinical Study Report," "Regulatory Writing Must Be 'Fit for Function' Not Perfect," "Peer Review Revisited," "Importance of Language and Writing Style in a Clinical Study Report," and "Minimal Time and Effort Should be Applied to the Creation of the Clinical Study Report Synopsis.
From protocol development through final clinical study report -- we integrate deep clinical expertise with industry-leading technologies and a proven approach to support, streamline and expertly resource the entire product development process.
After the study is completed and the data are analyzed, medical writers commonly write the clinical study report and may also write submission summaries.
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