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Regulatory Coordinator6 of 6
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Module 1: Lesson 1
Conducting a regulatory gap analysis: methodology, scope, and documentation
Teaches a structured approach to regulatory gap analysis covering scope definition, data collection methods, finding classification, and documentation standards for site-level regulatory self-assessment.
The difference between an impression and an assessment
Every regulatory coordinator has walked through a study site and formed an impression. The training binders look thin. The delegation logs seem to lag behind staffing changes. The IRB correspondence files feel incomplete. These impressions are valuable -- they reflect accumulated professional judgment, and I would never tell you to ignore them. But an impression is not a gap analysis. And the distance between the two is precisely the distance between an opinion and evidence.
A gap analysis is a structured, reproducible assessment that compares your site's actual regulatory state against a defined standard -- and documents both the comparison and its findings with the rigor of an institutional quality record. It is, in the language of ICH E6(R3), a quality assurance activity -- what the Glossary defines in the audit context as "a systematic and independent examination of trial-related activities and records."
Module 1 established that inspection readiness is a continuous state, not a project. This lesson gives you the primary tool for maintaining that state: a methodology you can apply repeatedly, across every regulatory domain your site operates in, producing findings that are traceable, classified by severity, and documented well enough that a different regulatory coordinator could review your work and reach substantially similar conclusions.
That last point -- reproducibility -- is what separates a professional gap analysis from a walk-through. And it is what this lesson teaches you to build.
What you will learn
By the end of this lesson, you will be able to:
Regulatory Coordinator
Full course · Inspection Readiness and Regulatory Quality Management