QualityGlossary Term
ICH E6(R3) Section 1.46
All planned and systematic actions established to ensure that the trial is performed and data are generated, documented, and reported in compliance with GCP and applicable regulatory requirements.
Quality assurance encompasses the organizational systems, procedures, and activities designed to provide confidence that quality requirements for clinical trials will be fulfilled. QA operates at a strategic level, establishing the framework within which quality is achieved rather than checking individual outputs. This function is independent from trial operations to provide objective oversight and assessment of compliance with quality standards, GCP, and regulatory requirements.
The QA function typically includes developing and maintaining quality management systems, establishing standard operating procedures, conducting internal audits, managing corrective and preventive action programs, and providing compliance training. QA personnel review protocols and essential documents, evaluate vendor qualifications, assess risk management plans, and oversee continuous improvement initiatives. Their independence from operational responsibilities enables objective evaluation of trial conduct.
Quality assurance differs fundamentally from quality control, though the two functions are complementary. While QA focuses on building quality into processes and systems, quality control addresses the verification of specific outputs against requirements. A robust quality management system integrates both functions, with QA establishing the standards and systems that QC activities verify. Together, these functions ensure that clinical trials generate reliable data while protecting participant rights and welfare.
System implementation
"The quality assurance department developed a comprehensive quality management plan for the Phase III program, including risk assessment, audit schedules, and key performance indicators."
Process improvement
"Based on trends identified through audit findings, QA recommended revisions to the informed consent training program and updated the standard operating procedure for consent documentation."
A systematic and independent examination of trial-related activities and documents to determine whether evaluated activities were conducted in accordance with the protocol, GCP, and applicable regulatory requirements.
The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of trial-related activities have been fulfilled.
A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
A monitoring approach that focuses oversight activities on the most critical data and processes, allocating resources based on risk assessment rather than applying uniform monitoring intensity across all aspects of a trial.
A process of comparing data collected in the case report form against source documents to confirm that the data were transcribed accurately and completely.
ICH E6(R3) Section 1.46
All planned and systematic actions established to ensure that the trial is performed and data are generated, documented, and reported in compliance with GCP and applicable regulatory requirements.
Quality assurance encompasses the organizational systems, procedures, and activities designed to provide confidence that quality requirements for clinical trials will be fulfilled. QA operates at a strategic level, establishing the framework within which quality is achieved rather than checking individual outputs. This function is independent from trial operations to provide objective oversight and assessment of compliance with quality standards, GCP, and regulatory requirements.
The QA function typically includes developing and maintaining quality management systems, establishing standard operating procedures, conducting internal audits, managing corrective and preventive action programs, and providing compliance training. QA personnel review protocols and essential documents, evaluate vendor qualifications, assess risk management plans, and oversee continuous improvement initiatives. Their independence from operational responsibilities enables objective evaluation of trial conduct.
Quality assurance differs fundamentally from quality control, though the two functions are complementary. While QA focuses on building quality into processes and systems, quality control addresses the verification of specific outputs against requirements. A robust quality management system integrates both functions, with QA establishing the standards and systems that QC activities verify. Together, these functions ensure that clinical trials generate reliable data while protecting participant rights and welfare.
System implementation
"The quality assurance department developed a comprehensive quality management plan for the Phase III program, including risk assessment, audit schedules, and key performance indicators."
Process improvement
"Based on trends identified through audit findings, QA recommended revisions to the informed consent training program and updated the standard operating procedure for consent documentation."
A systematic and independent examination of trial-related activities and documents to determine whether evaluated activities were conducted in accordance with the protocol, GCP, and applicable regulatory requirements.
The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of trial-related activities have been fulfilled.
A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
A monitoring approach that focuses oversight activities on the most critical data and processes, allocating resources based on risk assessment rather than applying uniform monitoring intensity across all aspects of a trial.
A process of comparing data collected in the case report form against source documents to confirm that the data were transcribed accurately and completely.