Your Easy Guide to Clinical Studies

The Risk Assessment Form (RAF) is a tool used by the SP-INV to document and assess risks that threaten the defined Critical to Quality (CtoQ) factors of a study. 

 

The RAF provides support on how to:

• Identify risks to CtoQ factors (e.g. participant right and safety, data quality, study design complexity, target population, site feedback, lessons learned)
• Estimate risk occurrence (e.g. risk evaluation matrix)
• Assess risk impact on CtoQ factors (e.g. risk evaluation and prioritisation)
• Define risk control-measures, which includes the planning of  quality control and quality assurance aspects (e.g. monitoring scope, process adaptations, applicable SOPs/WIs, staff trainings)

 

The assessment of study risks begins during study planning (e.g. study feasibility assessment, protocol development).

 

Risk assessment is a continuous process remaining active throughout study conduct until completion. Therefore, the RAF document is a living tool, regularly updated to address changing or emerging new risks.

As a SP-INV:

• Implement a Quality by Design (QbyD) approach in your study, and define its CtoQ factors (i.e. aspects that stand out as being critical to the quality of your planned study)
• Identify risks that threaten the integrity of the study`s CtoQ factors
• Evaluate and prioritize risks, which will have an impact on the implementation of required risk control-measures. Note: risk control-measures should be fit for purpose and proportionate to the expected impact on CtoQ factors
• Consult experts able to assist in risk assessment (e.g.  relevant comments and suggestions from Site-INV and study staff)
• Ensure to document all information in the RAF, by keeping its content up to date and current

 

Implement a risk-based Quality Management System for the management of risks during study conduct.

 

Study risks may affect both time and resources needed to mitigate or prevent risk occurrence. These aspects must be considered when writing up the study budget.

References

ICH GCP E6(R3) – see in particular guideline

• 2.3 Responsibilities
• 3.10 Quality management

ICH E8(R1) – see in particular

• 3.1 Quality by Design of clinical studies
• 3.2 Critical to Quality Factors

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

• Risk management: Principles and guidelines

Documents

• Risk Assessment Form for Clinical Research Projects