Glossary of Clinical Research - Q

Q

  • Quality Assurance
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 GCP and the applicable regulatory requirement(s). (ICH E6)
  • Quality Control
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. (ICH E6)
  • Quality of life trials (or supportive care trials)
Refers to trials that explore ways to improve comfort and quality of life for individuals with a chronic illness. (NLM)

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