Module 5 Presentations

05/07/2024

Quality Assurance and Quality Control (2) (ICH GCP §5.1)

QUALITY ASSURANCE

QUALITY CONTROL

The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. ICH GCP §1.47

All those planned and systematic actions that are established to ensure that the trial is performed and the data generated (recorded) and reported in compliance with GCP and the applicable regulatory requirement(s). ICH GCP §1.46

The Organisation for Professionals in Regulatory Affairs

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Monitoring (ICH GCP §5.18)

Verifies that:

• The rights and well-being of human subjects are protected

• The reported trial data are accurate, complete, and verifiable from source documents. • The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s)

The Organisation for Professionals in Regulatory Affairs

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