In an update to the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) guidance on good clinical practices (GCPs), definitions for the inspection outcome terms “critical,” “major” and “other” have been provided.
The three terms are used by the MHRA to indicate the significance of the findings of their GCP inspection teams. However, the GCP guidance lacked definitions for these key terms.
The new section on inspection outcomes explains three scenarios in which the MHRA will class a finding as critical. For example, a critical status may be applied to “significant and unjustified” departures from legislative requirements that may compromise the safety of patients or the reliability of clinical trial data.
The updated guidance also discusses when less severe failings will be classed as “major” and how it uses the catch-all outcome “other”.
To read more about good clinical practice for clinical trials and the new definitions, please click here.