Quality by Design in Clinical Research

In clinical research, “high quality” means that a study generates good, useful data, does not harm the study participants, and proceeds smoothly with few interruptions by errors or omissions. However, too many clinical research studies get mired in a time-consuming quality control (QC) process that generates numerous site monitor findings (e.g., missing data, ineligible study participants, other protocol deviations), data queries, and other after-the-fact indications that a quality problem has been found and needs to be fixed. A research site may be unable to deliver acceptable results, no matter how much the sponsor tries to help. In severe cases, the design of a study incorporates problems that make it impossible to achieve high quality results, no matter how well the study is conducted.

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