PCR 400 Module

PCR-400: Monitoring, Audits and Inspections Module

This course features the closely related topics of monitoring, audits and inspections. The online modules will allow participants to understand the purpose of site monitoring, responsibilities of monitors, and concepts surrounding risk-based monitoring; including the process of audits and inspections, conducted either by external parties and/or regulatory authorities.

Agenda

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

• An Introduction to Site Monitoring

• How to Conduct Site Monitoring (Site Monitoring Visit Preparation, Conduct & Follow-Up)

• Overview of Monitoring, Audits and Inspections

• Preparing for Audits and Inspections

• Risk-Based Monitoring: An Introduction

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

• Registration for this Course is currently open. Go to the Course Registration (via FormSG) here.

• For NHG Staff: Register here for the PCR course. Download the NHG Staff Self-Registration Guide for PCR Course here.