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?

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?