Page 229 - Safety Risk Management for Medical Devices

208 Safety Risk Management for Medical Devices

26.5 RISK DOCUMENTATION REQUIREMENTS
Risk management makes contributions to the required documents of clinical investi-
gations. Table 26.2 outlines the contribution of risk management to elements of the
clinical investigation documentation.

Table 26.2 Risk management input to clinical documentation
Clinical investigation document Risk management contribution
Clinical Investigation Plan (CIP) Summary of risk analysis
Anticipated adverse device effects
Identification of residual risks
Risk Controls
Benefit risk analysis summary
Investigator’s Brochure (IB) Summary of risk analysis
Anticipated adverse device effects
Identification of residual risks
Anticipated risks, contraindications, warnings, etc.
Benefit risk analysis summary
Results of risk assessment
Clinical Investigation Report (CIR) Benefit risk analysis summary
Adverse events
Adverse device effects
Informed Consent Form (ICF) Anticipated adverse device effects