Risk Management in Clinical Research

An overview of risk management

• Why risk management is important?
• Definitions of key risk management terminology
• Regulations and guidelines which cover risk management applied to clinical study-level risk management

Risk-based QM system – what does this really mean? How does it look?

• What are the elements of QM system and what a regulatory inspector would expect to be in place for clinical trials
• Group discussion – participants share what systems they have in place

Risk-based process/tools and techniques

• Examples of risk management process
• Risk-based tools including
  • Root cause analysis – 5 Whys
  • Risk register
  • Risk matrix
  • Examples of pharmaceutical risk tools for clinical trials including RACT (Risk Assessment Categorization Tool)

Risk-based approach to the protocol

• Quality by design (QbD) applied to the protocol
• How this is being applied to the design of protocols

Risk-based approach to monitoring/data handling

• Different approaches to risk-based monitoring and examples of how this is carried out – eg of a risk-based monitoring plan
• Discussion of what approaches and documents are used
• Case study example

Brief review of risk-based approaches to QC/QA (Auditing)

• Example of best practice guide RQA (Research Quality Association)

Final Discussion