Benefit-Risk Assessment Template - Free Digital Form

Benefit-risk assessment template

A benefit-risk assessment template provides an organized framework for evaluating potential gains against possible downsides of business decisions, projects, or product launches. We created this template specifically for documenting your decision-making process in a regulated environment. Unlike generic risk assessments, this template balances opportunity analysis with risk evaluation, helping you justify decisions to stakeholders and regulatory bodies.

For example, pharmaceutical companies can use it to document their rationale for advancing drug candidates through development stages. The template includes weighted scoring mechanisms to quantify both benefits and risks, providing clear decision support.

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Preview of the template

Page 1

Product Information

Product Name

Product Description

Intended Use

Therapeutic Area

Benefit Assessment

Demonstrated Efficacy

Intended Patient Population

Unmet Medical Need

Impact on Quality of Life

Risk Assessment

Serious Adverse Events

Discontinuation Rate

Severity of Adverse Events

Contraindications

Warnings and Precautions

Benefit-Risk Profile

Overall Benefit-Risk Assessment

Justification

Recommendation

Frequently asked questions

How do I quantify benefits in a benefit-risk assessment template?

You can quantify benefits by assigning numerical values to factors like financial gain, market share growth, operational efficiency, and strategic alignment. Our template includes customizable scoring criteria (1-5 scale) for each benefit category. For financial benefits, you can use projected ROI percentages, or for strategic benefits, rate alignment with company goals.

What’s the difference between a risk assessment and a benefit-risk assessment?

A standard risk assessment focuses only on identifying potential hazards and evaluating their likelihood and impact. A benefit-risk assessment goes further by weighing these risks against potential benefits of proceeding with a decision or action. This balanced approach provides context for accepting certain risks when benefits justify them.

What documentation should accompany a completed benefit-risk assessment?

Supporting documentation should include data sources used for benefit calculations, evidence supporting risk probability estimates, relevant industry benchmarks, applicable regulatory guidelines, and records of stakeholder consultations. Our template includes attachment fields for these documents, creating a comprehensive assessment package.

What are the most common mistakes when conducting benefit-risk assessments?

Common mistakes include confirmation bias (favoring data that supports desired outcomes), overlooking low-probability/high-impact risks, inadequate stakeholder consultation, and failing to document assumptions. Our template addresses these issues with structured evaluation sections, required fields for diverse perspectives, and dedicated areas for documenting assumptions.

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.