Good Clinical Practice (GCP)Course 2 of 2

Good Clinical Practice (GCP)

Full course · ICH E6(R3) Principles

Qualifications, training, and resources — ICH E6(R3) Principles

Qualifications, training, and resources

Learn the specific regulatory requirements for investigator qualifications, product familiarity, and resource documentation that must be established before a clinical trial begins at any site.

25 min

Qualifications, training, and resources

Before a single participant is enrolled, before the first dose is dispensed, before any trial-related procedure occurs, a fundamental question must be answered: Is this investigator ready?

Readiness is not merely a matter of willingness. An investigator may be eager to participate in a trial, genuinely committed to advancing medical knowledge, and deeply invested in helping patients. But eagerness, commitment, and good intentions are insufficient. The regulatory framework demands something more concrete. It demands documented evidence that the investigator possesses the qualifications to conduct the trial safely and competently, understands the investigational product thoroughly, and commands the resources necessary to execute the protocol as designed.

This is not bureaucracy for its own sake. Consider what happens when these requirements are not met. An investigator unfamiliar with the investigational product's adverse event profile may fail to recognize an emerging safety signal. A site that overcommits to enrollment targets may find itself unable to complete required follow-up visits, resulting in missing data that compromises the trial's scientific integrity. A research team lacking adequate training may make systematic errors in critical assessments, introducing variability that obscures the treatment effect.

Sections 2.1 and 2.2 of ICH E6(R3) Annex 1 establish the specific requirements that must be satisfied before trial conduct begins. These requirements translate the broad principle of qualified individuals into actionable criteria. They answer the practical questions: What must the investigator know? What documentation must exist? What resources must be available?

What you will learn5 objectives

By the end of this lesson, you will be able to:

Demonstrate investigator qualifications through education, training, and experience (Section 2.1.1)
Ensure investigator familiarity with the investigational product, Investigator's Brochure, and protocol (Section 2.1.2)
Document recruitment potential with adequate evidence and realistic projections (Section 2.2.1)
Verify sufficient time, an adequate number of available and qualified staff, and adequate facilities before trial initiation (Section 2.2.2)
Prepare documentation that provides evidence of qualifications as required by sponsors, IRBs, and regulatory authorities

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Qualifications, training, and resources