If you’re running or overseeing a study, a risk-based monitoring plan template helps you focus your monitoring efforts where it matters most. Instead of wasting time on low-risk sites or tasks, you can use this template to standardize your approach, assign roles, and document processes clearly across teams. It enables you to streamline trial oversight while improving preparation for inspections.
Why you should use a risk-based monitoring plan template
This template gives you a clear, structured way to manage high-impact risks that could derail patient safety or data integrity in a trial. Instead of building a plan from zero for every study, you get a consistent framework that cuts down on errors and unnecessary effort.
With this template, you can identify risks, map out monitoring strategies, assign responsibilities, and keep the information documented in one place. Your team can then stay team aligned and audit-ready.
It also enables you to make the most of your resources by prioritizing critical data and safety concerns while scaling back on low-risk activities. You’ll also find it easier to standardize your approach across multiple studies, so you’re not starting from scratch every time.
How to use the risk-based monitoring plan template
You can make the most of the template with these steps:
- Customize the template to match your study. Start by editing the template in the app to reflect your trial’s scope, risk profile, and regulatory requirements. Add or remove fields, adjust categories, and define your own thresholds based on study complexity and phase.
- Outline key risks and assign categories. Use the form to clearly document potential risks, such as protocol deviations or missing data. You can then categorize them by patient safety, data integrity, or operational impact.
- Define monitoring methods and responsibilities. Map out how each risk will be monitored and who’s responsible. Whether it’s site visits, central monitoring, or remote checks, being clear here allows you to avoid duplication and skipped steps down the line.
- Use role assignments to drive action. Once your plan is filled in, assign it to a responsible team member via the app. That person owns the task, but everyone can view results and follow up on required actions.
- Track progress and update as the trial evolves. Monitoring needs will change as your study progresses. You can leverage Lumiform’s analytics to spot trends, track risk indicators, and update the plan directly.
Download Lumiform’s risk-based monitoring plan template for clinical trials
Gain clear oversight of responsibilities, timelines, and risk priorities from the start. With Lumiform, you delegate tasks and define thresholds as well as monitor insights as they develop. This template offers a systematic, audit-ready format that’s both adaptable and practical. Integrate it into your workflow and establish a more efficient, consistent monitoring process from day one.