Preliminary Report on the Use of High-Fidelity Simulation in the Training of Study Coordinators Conducting a Clinical Research Protocol

In Brief Training of health care research personnel is acritical component of quality assurance in clinical trials. Interactivity (such as simulation) is desirable compared with traditional methods of teaching. We hypothesized that the addition of an interactive simulation exercise to standard training methods would increase the confidence of study coordinators. A simulation exercise was developed to replicate a complex clinical trial. Eighteen study coordinators completed pre- and postexercise confidence questionnaires. Questions were targeted at key trial components using a 0–10 scale (not confident to confident) and were categorized using Bloom’s Taxonomy. The primary analysis compared overall mean pre-and postexercise responses. Secondary analyses assessed affective, psychomotor, and cognitive confidence. Significance was at P < 0.05. A significant increase in overall confidence…