Module 5 Presentations

05/07/2024

In this presentation we will cover

• History, objectives and basic principles of GCP • Quality & Compliance & Audits & Inspections • Fraud & Misconduct in clinical research • Case studies & Examples

The Organisation for Professionals in Regulatory Affairs

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Quality Assurance and Quality Control (1) (ICH GCP §5.1)

• Sponsor should implement quality assurance (QA) and quality control (QC) control systems (QMS = Quality management system) with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, documented (recorded) and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s).

• Direct access to documents required

• QC at each stage of data handling

All agreements in writing

•

The Organisation for Professionals in Regulatory Affairs

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