Practical Issues in Clinical Inspection Process

Regulatory inspection of clinical trial is necessary in order for (1) assessing compliance with statutory requirements and regulatory requirement governing the conduct of clinical trials and (2) verifying the accuracy and reliability of clinical trial data submitted to regulatory agencies such as the United States Food and Drug Administration (FDA) in support of research or marketing applications. This article provides an overview of clinical inspection process and issues that are commonly encountered during the conduct of clinical trials. In addition, a couple of sampling plans for clinical inspection of relatively large trials are proposed. The proposed statistical process for clinical inspection that will achieve a desired degree of inspection accuracy and reliability is useful when the resources of inspectors are limited. The proposed 2-stage sampling plan can be applied to clinical inspection for multicenter and/or multinational multicenter clinical trials.