Performance Problem
Clinical Research Site Monitors are the eyes and ears of a clinical study sponsor. They ensure patient safety, data quality, compliance with the research protocol, and compliance with FDA regulations. Accuracy and completeness of a monitor's work come to light during an external investigation. Managers were uncertain about monitors' competencies. The risk is an expensive delay in a clinical trial.

Comprehensive Solution
We created an online approach, facilitated by a subject matter expert, which new hires and promotees could take immediate advantage of. Training blends the following approaches, as shown in the graphic:

• Six modules of online training with interactive presentations and practice
• Challenge activities: simulated functions
  Classroom simulation of a monitoring visit to a research site
• Competency assessment

The Performance Clinic
Participants start the course by assessing their skills with the assistance of a competency map. Each module ends with a performance test on a portion of the job.

If participants already have a competency, they start with the performance clinic (the challenge activity). They receive feedback from a subject matter expert who serves as coach for the course.

Some of the skills are interpersonal, so a classroom-based performance clinic allows them to work with simulated roles, such as the principal investigator, site coordinator, and other personnel.

To complete the course, trainees conduct a complete simulated site visit using data from another site.

Results
The business driver for this project was to reduce risk. This course, the challenge activities, and the assessment - all based on simulations of actual situations in a safe lab enrivonment, reduced risk by providing a solid baseline on skills grounded in actual performance.