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Risk-based monitoring plan template

Risk-based monitoring plan template

Build an inspection-ready monitoring plan that supports you in prioritizing study risks, assigning responsibilities, and keeping oversight consistent from start to finish.

Use this template
or download pdf
Risk-based monitoring plan template

Build an inspection-ready monitoring plan that supports you in prioritizing study risks, assigning responsibilities, and keeping oversight consistent from start to finish.

Use this template
or download pdf

About the Risk-based monitoring plan template

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

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Preview of the template
entity_item!!!
Page 1
Risk Identification
Identify key risks associated with the study
Categorize risks (e.g. patient safety, data integrity, etc.)
Assess the likelihood and impact of each risk
Monitoring Strategies
Describe monitoring methods for each risk
Identify data to be collected and source
Specify monitoring frequency and thresholds
Define roles and responsibilities
Quality Assurance
Outline quality control measures
Describe process for addressing identified issues
Plan for independent review and oversight
Reporting and Escalation
Specify monitoring report content and frequency
Define thresholds for escalating issues
Outline communication plan and stakeholders
Continuous Improvement
Describe process for reviewing and updating the plan
Incorporate learnings and best practices
Ensure plan remains fit-for-purpose

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Related resources

Access a complete set of resources aimed at maximizing safety, quality, and operational excellence, including detailed guides, related templates, and real-world use cases.

Topic guides

Read in-depth guides covering key topics related to this article.

Effective risk assessment: Key steps and best practicesDynamic risk assessment: Your guide to proactive management (with real world case studies)Chemical hazards: A mandatory risk assesment guide (with examples for businesses & industries)
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Template collections

See comprehensive collections of best practice templates related to this topic.

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Use cases

Check out how the Lumiform software can be utilized for related use cases.

Risk monitoring softwareIT risk assessment softwareKey risk indicators softwareProject risk management software
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Other resources

Explore all the additional resources we offer to assist you in mastering this topic.

5 types of project risksHow to develop a risk registerDisaster risk management: the philosophy of disaster preparedness4 benefits of safety management and how to communicate them

Frequently asked questions

What should be included in a risk-based monitoring plan?

A solid plan includes more than just a list of risks. It maps out how you’ll detect, assess, and respond to them. You’ll want to detail monitoring methods, data sources, frequency, thresholds for action, and who’s responsible for each part. Don’t forget to include how you’ll revise the plan as the study evolves.

How do you identify risks before the trial starts?

Start with protocol review meetings and cross-functional input from clinical ops, data management, QA, and even investigators. Use past trial data, audit findings, and similar studies to spot common problem areas. You can conduct risk brainstorming workshops to reveal hidden issues early on, especially when people from different roles share insights.

Can a risk-based monitoring plan change mid-study?

Yes—and it should. Risks shift as trials progress, especially after interim analyses, protocol amendments, or when site performance trends change. Set a recurring checkpoint (monthly or per milestone) to reassess risks. Updating your plan shows proactive oversight and helps you stay compliant during inspections.


This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.
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