The Good Clinical Practice guideline: a bronze standard for clinical research

GCP emphasises clinical monitoring and data audits to confirm that clinical trial data are "verifiable from source documents."1 Key objectives are detection of fraud and accurate transcription of data. We support both goals, but whether the methods of GCP achieve them is unclear. Although intensive monitoring of clinical sites and auditing of research could help prevent or detect fraud,14 "fraud in clinical trials is so rare and . . . generally inconsequential, that the public may be far more misguided by studies that are poorly designed, wrongly analysed and inappropriately reported than by fraud."15 Moreover, monitoring confirms consistency between data collection forms and source documents; if the source documents are wrong because of laboratory, clinical, or clerical errors, then monitoring adds expense without benefit. A common misinterpretation of sponsors is that GCP requires audits of 100% of data; by contrast, random audits might suffice.