Clinical Trial Risk Assessment Template – Download PDF

Clinical trial risk assessment template

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.

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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.