What is the primary function of the Quality Assurance (QA) Team regarding trial standards?

Answer

Developing and maintaining the Quality Management System (QMS) including SOPs.

The Quality Assurance (QA) Team, sometimes referred to as the Quality Specialist, is tasked with establishing the formal framework for ensuring quality control throughout the clinical trial process. Their central responsibility involves developing and continuously maintaining the Quality Management System (QMS). This QMS is operationalized through detailed Standard Operating Procedures (SOPs), which serve as governing documents detailing how all employees must perform their required tasks consistently. The QA team reinforces this system by training site personnel on the correct execution of these SOPs. Furthermore, they provide assurance of adherence through external checks, such as conducting systematic audits, thereby offering confirmation to stakeholders that patient safety is prioritized and data integrity is upheld by respecting all relevant regulatory standards.

What is the primary function of the Quality Assurance (QA) Team regarding trial standards?

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