Your Easy Guide to Clinical Studies

The Risk Assessment Form (RAF) is a supporting document that helps the SP-INV to identify, rate and document potential study risks. The tool gives guidance on how to estimate risk occurrence, its impact, including the implementation of required risk control-measures.

 

Study risk assessment starts during study feasibility assessment and protocol development.

 

The RAF documents:

• Study identified risks (e.g. based on complexity of study design, target group, site feedback)
• Defined risk control-measures, including implemented quality control and quality assurance aspects (e.g. monitoring scope, process adaptations, applicable SOPs/WIs, staff trainings).

 

Risk adaptations might also become necessary during study conduct. Consequently, risk identification and management (evaluation, prioritisation, definition of control measures) is a continuous process, starting at the time of protocol writing and only ending upon study completion. The RAF is a living document regularly evaluated during study conduct.

As a SP-INV perform a risk assessment of your study:

• Identify the potential study risks and define applicable risk control-measures
• Place special attention on risks impacting the safety of your study participant and the quality of study data
• Include experts able to assist in risk assessment and control
  • Consider comments and suggestions from the Site-INV and study staff
• Include risks identified during the feasibility assessment and study conduct
• Document all information in the RAF

 

Identified risks may require an increase in budget, time, and resources needed to mitigate or prevent their occurrence. These aspects must be considered when writing up the study budget.

References

ICH GCP E6(R2) – see in particular guideline

• 5.0 Quality management

ISO 31000 (access liable to costs) – see in particular section

• Risk management: Principles and guidelines

Documents

• Risk Assessment Form for Clinical Research Projects