Clinical trial (study) report
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Clinical trial (study) report is a comprehensive and formal document that provides a detailed account of a clinical trial's design, methodology, results, and conclusions. This report is essential for transparently documenting the study's objectives, methods, participant characteristics, data collection, statistical analyses, and outcomes. It serves as a critical component in the dissemination of trial findings, informs healthcare decisions, and aids regulatory authorities in evaluating the safety and efficacy of medical interventions.
Definitions
ICH E6
A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report [1] [2].
See also
Links to this page
- Quality control (← links)
- Glossary:Clinical trial (study) report (redirect page) (← links)
References
- ↑ ICH website, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
- ↑ ICH website, Structure and content of clinical study reports E3 https://database.ich.org/sites/default/files/E3_Guideline.pdf