PCR 004 Module

PCR-004: Monitoring, Audits and Inspections

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 differentiate between monitoring, audits and inspections and understand their respective roles in research oversight.

• To be familiar with the key activities required before, during, and after monitoring visits, audits, and inspections.

• To prepare for and follow up effectively on monitoring, audit, and inspection visits.

• To understand quality management and processes of Tissue Banks and Tissue Collections for compliance under the Human Tissue Framework.

• To identify common findings from audits and inspections and take appropriate corrective action.

Schedule

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

Registration

• For Non-NHG Health staff: Registration for this Course is currently open. Go to the Course Registration (via FormSG) here.

  Type of participants / Fees 

  • NHG Academic Partner / Joint Institutions / $267.05 

  • Non-NHG Healthcare Institutions / Academic Institutions / $400.58 

  • Others / Private / $534.10 

  Please note that all course fees quoted above are inclusive of 9% GST and for further enquries (e.g. Course Fee Category) please contact our training administrator at 6038 3669 or nhggroup.research.courseadmin@nhghealth.com.sg

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

Who should attend

This online course is designed for all research personnel, including Investigators, Clinical Research Coordinators, Research Assistants, Tissue Bank Custodians, Tissue Collection Applicants, Research Compliance Officers, Quality Assurance staff, and institution monitors.