Learning through simulation has historically been reserved for industries where even the smallest errors have major consequences. Clinical research is late to the party, only now realizing that the consequences of poorly trained staff, ranging from protocol deviations to site failures, can be avoided.
Training is a critical part of preparing for a clinical trial. Not only must investigators and other staff be trained in every relevant protocol, but regulatory requirements also call for proof that study staff have appropriate training in all activities they may perform.
Although most research sites have training procedures in place, problems related to insufficient training are frequently noted in FDA inspectional observations, including: issues related to protocol deviations, investigational product control, informed consent, and recordkeeping and reporting. In some cases, the FDA may make note of insufficient training; in others, the sites will point to training inadequacies as the cause of noncompliances. Thus, despite training being conducted, it is not always leading to compliance.