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NHG Health Office of Human Research Protection Programme (OHRPP)

PCR 004 Module

Overview of course and agenda

Last updated 14 August 2026

PCR-004: Monitoring, Audits and Inspections Module

This online PCR module covers the closely related topics of monitoring, audits, and inspections across all research types. Participants will understand the purposes, processes and preparation required for monitoring, audit and inspection by institution, sponsors and regulatory authorities. Common audit findings and corrective actions will also be covered in this module.

This online course encompasses the following topics related to monitoring, audits and inspections:

  • Overview of Monitoring, Audits and Inspections

  • Monitoring, Audits and Inspections activities and governing regulatory frameworks

  • Preparation and Follow-up Activities: Before, During, and After Monitoring Visits, Audits, and Inspections

  • Quality Management of Tissue Banks or Tissue Collections

  • Common Audit Findings: Impact and Corrective Actions

Learning Objectives

  • To apply concepts of risk-based monitoring to clinical trials.

  • To be familiar with the procedures to be followed before, during and after audits and inspections.

  • To prepare research studies for audits and inspections.

Schedule

This Online Course Module is available on a continuous basis (via E-Learning).

Registration