5.2.07 Risk assessment for clinical studies Estimated reading: 1 minute 220 views Authors Goal and purpose A process-related matrix of risks and risk assessments (risk indicators) with corresponding measures to reduce risks is created for all phases of a research project. The acceptability of residual risks is assessed. The acceptability of the residual risks is assessed. For the method, see 5.4.05 Application Description of the process Risks Resources Material Time required Documentation Responsibility and qualification Notes and comments Applicable documents Validation documents Terms Attachments 5.2 Analysis and validation - Previous 5.2.06 Planning and conducting clinical trials (Clinical Trial Manual) Next - 5.2 Analysis and validation 5.2.08 Creation of a risk matrix for treatment patterns