Glossary

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Q

Quality Assurance (QA)

Assurance de la qualité (AQ)-- Qualitätssicherung (QA)

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.46

Keyword(s):

Quality Control (QC)

Contrôle de la qualité (CQ) -- Qualitätskontrolle (QC)

The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.

International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.47