Clinical Trial Risk Management Plan Tool


A Clinical Trial Risk Management Plan outlines how to manage risks in a clinical trial because it serves as the basis for all other risk management activities, including risk identification, assessment, mitigation, and monitoring.

Cyntegrity’s Clinical Trial Risk Management Plan Tool helps you save time and effort because it provides structure and guidance toward each aspect of your risk management plan. Therefore, you can use this template to document how risks will be managed in your clinical trial.

The RMP Tool contains guidance for the following parts of the plan:

  • Roles and responsibilities
  • The rationale for the application of RBQM in a clinical study
  • Risk identification
  • Risk assessment and categorization tool (RACT)
  • Quantitative risk analysis
  • The data sources and the underlying risk
  • Mitigation strategy and response plan
  • Planned RBQM Reports
  • Risk monitoring process
  • Communication of risks
  • Risk review
  • Revision of the RACT
  • Lessons learned process
  • Data archiving and provision of final materials to the sponsor

The two editable MS Word files can be downloaded immediately after the successful completion of your payment. An invoice will be automatically sent to your email address.


Interested in other Cyntegrity tools that provide clinical study risk management and optimization strategies?

Here at Cyntegrity, our mission is to help pharmaceutical companies stay GCP compliant, improve patient safety, make a clinical study more predictable and optimize monitoring resources. Because we stay true to our mission, our tools and resources are built to reflect it. Therefore, make use of the resources and tools our data experts have perfected through years of clinical data research. Check how you can optimize your clinical trial management here.


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