Creating an FDA-Ready Moderator’s Script for Your Human Factors Validation Study
White Paper + Companion FAQ
Published by Margarita Cajina, Senior Human Factors Engineer, Interface Analysis Associates LLC (IAA), and Anthony Andre, PhD, CPE, Founding Director, IAA
Developing a Clear, Traceable, and Effective Validation Study Script
The moderator’s script is a central component of a human factors validation study. It translates the study protocol, Instructions for Use (IFU), Use-Related Risk Analysis (URRA), and FDA guidance into a practical tool for conducting study sessions consistently.
This white paper provides practical guidance for developing an FDA-ready moderator’s script. It covers key inputs, script structure, performance and knowledge tasks, debriefing techniques, data collection, and strategies for maintaining traceability between the IFU, URRA, study tasks, and evaluation measures.
What You’ll Learn
- The role of the moderator’s script in validation studies
- Key inputs, including the IFU, URRA, training, and use environments
- How to structure performance tasks, knowledge tasks, and debriefs
- Best practices for neutral, non-leading participant interactions
- How to maintain traceability between the IFU, URRA, and study measures
- When to create separate scripts for different user groups or scenarios
- Key differences between formative and validation study scripts
- Strategies for improving consistency and FDA readiness
Download the Resources
White Paper
Creating an FDA-Ready Moderator’s Script for Your Human Factors Validation Study
Explore practical recommendations for developing a moderator’s script that supports realistic study conditions, consistent execution, unbiased participant interaction, regulatory traceability, and effective data collection.
Companion FAQ
Frequently Asked Questions About Human Factors Validation Study Scripts
Get quick answers to common questions about moderator’s scripts, FDA expectations, labeling, and more.
Have questions about developing a moderator’s script or planning a human factors validation study? Contact Interface Analysis Associates to discuss your unique development and regulatory needs.
