International Council for Harmonisation Guidelines

Flashcards based on ICH guidelines and terminology relevant to clinical trials.

ICH

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

GCP

Good Clinical Practice, a standard for designing and conducting clinical trials.

E6(R2)

The ICH Harmonised Guideline Integrated Addendum to ICH E6(R1), providing updated GCP standards.

ADR

Adverse Drug Reaction, noxious and unintended responses to a medicinal product.

SAE

Serious Adverse Event, a medical occurrence that results in death, is life-threatening, requires hospitalization, or results in significant disability.

IRB

Institutional Review Board, responsible for ensuring ethical oversight of clinical trials.

CRO

Contract Research Organization, an entity contracted by the sponsor to perform clinical trial-related duties.

Informed Consent

A process by which a subject voluntarily confirms their willingness to participate in a trial.

Audit

A systematic examination of trial-related activities and documents to ensure compliance with protocols and regulations.

Randomization

The process of assigning trial subjects to treatment groups randomly to reduce bias.