Creating the moderator’s script, or guide, for a human factor’s validation study is perhaps the most critical aspect of the study’s development. The validation protocol defines the study objectives, scope, and measures, while the validation script ensures the study is conducted consistently, data is collected properly, and FDA requirements are met. Your study and its outcome are directly tied to the validation script. There are certain elements that are required/desired by the FDA as well as elements we have perfected that help optimize the script and aid the moderator.
A well-designed moderator’s script will provide a usable structure for the session, support a good session flow, and allow the moderator to know when to debrief a use error, close call or difficulty, among other benefits. In this webcast, we apply more than 30 years of experience in developing moderator’s scripts for validation studies, with the feedback of hundreds of FDA reviews, to provide attendees with a tried-and-true method and format for your moderator’s guide.
Learning Objectives
- How to construct an effective and FDA compliant moderator’s script/guide for a validation study.
- Develop a useful format for observing use errors, close calls and difficulties.
- Learn when and where debriefs should be inserted into the script.
- How to construct open-ended knowledge tasks.
Who Should Attend?
The ideal audience are those who create human factors validation protocols, review them or approve them prior to execution or submission to the FDA, and those that want to learn more about these protocols.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected]
Anthony Andre
Margarita Cajina
