Quality Assurance

The Sponsor is responsible for the implementation of a system of Quality Assurance in order to ensure that the Study is performed and the data is generated, recorded and reported in compliance with the Protocol, GCP and other applicable requirements.  Documented Standard Operating Procedures are a prerequisite for quality assurance.

All observations and findings should be verifiable, for the credibility of the data and to assure that the conclusions presented are correctly derived from the Raw Data. Verification processes must therefore be specified and justified. 

Statistically controlled sampling may be an acceptable method of data verification in each Study.  Quality control must be applied to each stage of data handling to ensure that all data are reliable and have processed correctly.

Sponsor’s audits should be conducted by persons independent of those responsible for the Study. Investigational sites, facilities, all data and documentation should be available for inspection and audit by the Sponsor’s auditor as well as by the Regulatory Authority(ies).

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Definitions, Pre-requiste for the study, Responsibilitiles, Record Keeping and Data Handline, Quality Assurance, Statistics, Special Concerns, Appendices