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A Practical Guide to FDA 21 CFR Part 11 Compliance
FDA 21 CFR Part 11 is the regulation that establishes the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. For organizations in the pharmaceutical, biotechnology, and CRO sectors, this regulation
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A Practical Guide to ICH Guidelines for Clinical Trials
The ICH guidelines for clinical trials represent a harmonized international standard for the design, conduct, monitoring, recording, analysis, and reporting of clinical research involving human participants. This unified framework is intended to ensure that clinical data submitted to regulatory authorities, such as the FDA, EMA, or PMDA, is mutually acceptable across these regions. The Purpose
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Statistical Analysis Plan Template: A Guide for Clinical Trials Documentation
A statistical analysis plan template is a standardized, regulatory-aligned framework that details the specific methods for analyzing clinical trial data. It serves as a comprehensive blueprint for the analysis, ensuring all procedures are prospectively defined, objective, and reproducible. This technical document expands upon the high-level statistical concepts from the clinical trial protocol, providing a granular,
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A Guide to the Clinical Study Report Template for Regulatory Submissions
A clinical study report (CSR) template serves as the standardized framework for authoring the comprehensive account of a clinical trial for regulatory authorities. This structured blueprint, designed in accordance with guidelines like ICH E3, ensures that all critical information is presented logically and consistently for review by agencies such as the FDA and EMA. The
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A Guide to Protocol Development for Clinical Trials
A clinical trial protocol is the detailed, formal plan for a research study. It is the single source of truth that defines the study's objectives, design, methodology, statistical considerations, and organizational structure. Its purpose is to ensure the safety of trial participants and the integrity of the data collected. The Protocol's Role in Clinical Operations