Quality assurance (QA) – is a systematic process aimed at ensuring that conduct of a study adheres to established regulations, standards, and guidelines, providing confidence that integrity of study data and its results is consistent with predefined quality requirements.
QA aims to prevent issues before they occur.
Definitions
ICH E6(R2)
- 1.46 Quality Assurance (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) [1].
ICH Q7
- Quality Assurance (QA):
- The sum total of the organised arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained [2].
ISO 9000:2015 Quality management systems
- 3.3.6 quality assurance:
- part of quality management (3.3.4) focused on providing confidence that quality requirements (3.6.5) will be fulfilled [3].
Quality assurance procedures and practices
QA is a proactive process that ensures that the conduct of the study adheres to protocols, regulations, and good clinical practice (GCP) guidelines in predefined extent. It involves overseeing the overall quality of the study, including verifying participant safety, data accuracy, protocol compliance, evaluating the quality of data collected, etc. Examples of QA procedures includes:
- site monitoring to evaluate the conduct of the study, verify the accuracy and completeness of study documentation, and assess adherence to protocol and regulatory guidelines.
- training of study personnel on GCP guidelines, regulatory standards and particular protocol requirements
- documentation and record keeping of all study-related activities, including source medical records, informed consent documents, regulatory submissions, monitoring reports and correspondence
- investigational product management including handling, storage, dispensing, and administration of study drug
- quality checks on study documentation, data collection tools, and study procedures to identify and address any errors, inconsistencies, or deviations from protocol
- audits and inspections to evaluate the overall quality and compliance of the study and identify areas for improvement
Implementation of these quality assurance activities and procedures can enhance the reliability, validity, and credibility of research findings.
See also
Another relevant pages
Links to this page
References
- ↑ ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023
- ↑ ICH, 2000, Harmonised tripartite guideline Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients https://database.ich.org/sites/default/files/Q7 Guideline.pdf Accessed May 2024
- ↑ ISO, 2015, ISO 9000:2015 Quality management systems – Fundamentals and vocabulary, https://www.iso.org/obp/ui#iso:std:iso:9000:ed-4:v1:en:term:3.3.6 Accessed May 2024
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