Clinical trials (CT) are the ultimate test of the development hypothesis that conditions can be identified under which a novel medicinal product can be shown to be a safe and efficacious treatment option. CTs and the documentation of their orderly planning, conduct, analysis, and reporting are essential in the regulatory profiling of new drug products and substances. CTs expose trial participants to risks and inconvenience with little (while time-limited) or no (while placebo-treated) individual medication-related benefit; this constraint is particularly obvious in early clinical development when investigating healthy subjects or when investigating patients with out-of-scope doses. Therefore, a favourable benefit:risk-relation requires minimising individual risk and maximising group-ethical benefit (for the future treatment of other patients).
In consequence, there is need to establish Quality Management (QM) Standards that account for at least two risks: i) the clinical safety risk to the trial participants and ii) the quality risk that limiting GCP-defects may occur that would invalidate the trial.
This has immediate implications at several levels: i) select appropriate sites, ii) qualify the sites & investigators for the purpose of the trial, iii) provide guidance & instructions by means of a well-conceived QM-Plan, iv) implement the plan by providing instruction & training, and v) monitor adherence to the QM-Plan. Keep records on track!