Stay in Compliance and Save Time with the AQC Risk-Based Monitoring Plan Template

Posted in Risk Mitigation

AQC Tool Highlight: Risk-Based Monitoring Plan Template

The FDA has established Risk-Based Monitoring guidance* which encourages sponsors to tailor monitoring plans to the needs of the investigation, describes factors to consider in developing a monitoring plan, and provides examples of monitoring methods and techniques. The FDA believes risk-based monitoring is an important tool to allow sponsors to identify and address issues during the conduct of clinical investigations.

In alignment with FDA’s recommendations on Risk-Based Monitoring, WCG Avoca has developed a Risk-Based Monitoring Plan Template which provides:

  • Instruction for Sponsor/CRO oversight activities which focus on critical data and processes with the intention of mitigating those that will impact data quality, human subject protection, and reliability of trial results.
  • Support and corresponding resources for identifying risks in a Quality Risk Management Plan (IQRMP) and setting Quality Tolerance Limits (QTLs) and Key Risk Indicator thresholds, so that resources can focus on monitoring activities that provide the most value.
  • Assistance for ensuring that the rights, confidentiality, and safety of human subjects are protected; that trial data are accurate, complete, and verifiable; and that the study is compliant with the protocol, Good Clinical Practice (ICH/GCP), and all applicable regulatory requirements.
  • An efficient monitoring strategy that best aligns with any heightened or critical risks of a particular trial with the intent to prevent the realization of those risks; to ensure early detection of impactful issues; to control those risks to an acceptable level; and to correct all significant and critically impactful issues while the trial is ongoing.
  • Adequate information for those involved in monitoring to effectively carry out their monitoring duties, taking into account the objectives of monitoring when applying a risk-based strategy.

AQC Members can access the Risk-Based Monitoring Plan Template in the Knowledge Center here.

This is just one of many risk-based tools available to WCG Avoca Quality Consortium Members in our Knowledge Center, which consists of over 500 regulatory compliant leading practice tools and templates customizable to their organization to be inspection ready. View the current catalog of tools.

Interested in joining the AQC? Contact us and join our next monthly Knowledge Center demo.