Applicable regulatory requirement(s)

Applicable regulatory requirement(s) refers to the laws and regulations governing the conduct of a clinical investigation or other regulated clinical research activity within a particular jurisdiction. The applicable requirements depend on the type of study and the country or region in which it is conducted.

Regulatory definitions

ICH E6(R3) (Guideline for Good Clinical Practice)

Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products 1.

Scope

Applicable regulatory requirements may govern various aspects of a clinical trial, including:

  • authorization and oversight of clinical trials
  • protection of trial participants
  • informed consent
  • safety reporting
  • investigational product management
  • data recording, retention, and inspection
  • responsibilities of sponsors and investigators

The specific requirements vary between jurisdictions. For example, clinical trials conducted in the European Union are subject to the applicable EU legislation and national implementing laws, whereas trials conducted in the United States must comply with applicable requirements established by the U.S. Food and Drug Administration (FDA) and other relevant federal regulations.

Related terminology

The term applicable regulatory requirement(s) refers specifically to legally binding laws and regulations. It should be distinguished from guidance documents, standards, or recommendations, which may influence clinical trial conduct but do not have the same legal status unless incorporated into applicable legislation.

See also

  • Clinical Trial
  • Good Clinical Practice (GCP)
  • ICH E6
  • Regulatory Authority

References

  1. International Council for Harmonisation. 2026. ICH E6(R3): Consolidated Guideline for Good Clinical Practice.
    Available at: https://database.ich.org/sites/default/files/ICH%20E6%28R3%29_Step4_FinalConsolidatedGuideline_2026_0616_.pdf ↩︎