Templates
Clinical trial risk assessment template

Clinical trial risk assessment template

Use this template to analyze clinical trial risks step-by-step in compliance with ICH-GCP standards.

Use this template with Lumiform

The Lumiform application helps frontline teams uphold internal standards effortlessly.
  • Customize this template or build your own
  • Fill out templates via mobile app
  • Assign and track corrective actions
  • Get reports and analyse your data
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or Download template as PDF
Clinical trial risk assessment template

Use this template to analyze clinical trial risks step-by-step in compliance with ICH-GCP standards.

Use this template with Lumiform

The Lumiform application helps frontline teams uphold internal standards effortlessly.
  • Customize this template or build your own
  • Fill out templates via mobile app
  • Assign and track corrective actions
  • Get reports and analyse your data
Prices start from ░░░ per month
Book a demo
Learn more
or Download template as PDF

Our clinical trial risk assessment template gives you a clear framework to identify, document, and address the specific risks that can affect clinical research, from patient safety to data quality and regulatory compliance. You can map out every step of your trial protocol, flag high-risk activities, and assign mitigation measures. This way, your team can prevent protocol deviations and ensure robust documentation across sites.

According to the Tufts Center for the Study of Drug Development, around 76% of Phase I to IV clinical trials need amendments. This trend highlights the importance of proactive risk assessment to keep trials on track. For related needs, see our project, vendor, or ISO 14971 risk assessment templates.

Related categories

Preview of the template
Page 1
Trial Overview
Trial Phase
Trial Purpose
Trial Duration
Number of Participants
Participant Population
Investigational Product
Product Type
Mechanism of Action
Formulation
Route of Administration
Prior Clinical Experience
Regulatory Considerations
Regulatory Approvals Obtained
Potential Regulatory Risks
Clinical Site Information
Number of Clinical Sites
Site Experience with Investigational Product
Site Infrastructure Capabilities
Site Monitoring Plan
Patient Population Risks
Participant Recruitment Feasibility
Participant Retention Risks
Participant Inclusivity
Participant Vulnerability
Safety Considerations
Anticipated Adverse Events
Potential Safety Signals
Mitigation Strategies
Overall Risk Assessment
Risk Level
Justification
Mitigation Plan

Frequently asked questions

What risks are commonly identified in clinical trial risk assessments?

Common risks in clinical trials include protocol deviations, participant safety issues, incomplete or inaccurate data, delays in enrollment, supply chain interruptions, and problems with informed consent. There are also risks related to data privacy, site compliance, and adherence to Good Clinical Practice guidelines.

How can you prioritize risks during a clinical trial risk assessment?

You can prioritize risks by evaluating both their likelihood and potential impact on trial outcomes or participant safety. Typically, you would use a risk matrix, which scores risks by severity and probability. This allows teams to focus resources on mitigating the most significant threats first and ensuring compliance with regulatory expectations.

What are common challenges when performing clinical trial risk assessments?

Organizations often struggle with limited resources, complex protocols, and rapidly changing regulations. Coordinating risk management across multiple sites and teams can be difficult, especially with evolving data and tight timelines. An organized approach and standardized tools can help reduce frustration and ensure you keep track of all key details.

What types of data quality risks can impact a clinical trial?

Data quality risks include missing data, inaccurate entries, inconsistent measurements, or delayed data capture. These problems can compromise study results and regulatory submissions. A clinical trial risk assessment allows teams to set up checks, controls, and contingency plans to protect data integrity from start to finish.

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.