Good Clinical Practice E6 (R3) Practice Test

A systemic issue is a problem that affects multiple processes or the entire trial, not just a single isolated event. It points to a flaw in the trial’s systems or procedures that can impact data integrity, participant safety, or compliance across sites. For example, a fault in the data capture software used at several sites, or consistent protocol misinterpretation due to insufficient training, would be systemic because it influences the study as a whole. In contrast, problems confined to one site with no wider impact, or a data entry error that happens only once, are isolated incidents and do not indicate a systemic issue. A late ethics approval at a single site is likewise an administrative delay limited in scope; it would become systemic only if it recurred across multiple SAMPLEsites or reflected a broader process failure.