Quality assurance (QA) and quality control (QC) are important components of clinical research, and are designed to ensure that the study is conducted in a consistent, accurate, and reliable manner.
Quality assurance refers to the overall process of ensuring
that the study is conducted in accordance with good clinical practices (GCPs)
and the study protocol. This includes activities such as training study staff,
monitoring the study to ensure that it is being conducted properly, and
identifying and correcting any issues that may arise.
Quality control, on the other hand, refers specifically to
the process of checking and verifying the quality and accuracy of the data
being collected in the study. This may include activities such as checking data
for errors or inconsistencies, verifying that data is being recorded correctly,
and ensuring that data is being stored and managed in a secure and consistent
manner.
Both QA and QC are essential to the success of a clinical
trial, as they help to ensure that the study is conducted in a reliable and
trustworthy manner, and that the data collected is of high quality. QA and QC
activities may be carried out by the study sponsor, the study site, or both,
depending on the specific requirements of the trial.