6.1 Quality of a clinical trial is considered in this guideline as fitness for purpose.
6.2 Factors critical to the quality of the trial should be identified prospectively. These factors are attributes of a trial that are fundamental to the protection of participants, the reliability and interpretability of the trial results and the decisions made based on those trial results. Quality by design involves focusing on critical to quality factors of the trial in order to maximise the likelihood of the trial meeting its objectives.
6.3 Strategies should be implemented to avoid, detect, address and prevent recurrence of serious noncompliance with GCP, the trial protocol and applicable regulatory requirements.