Problem: Using Sites with Limited Experience with Study Measures and Clinical Trial Conduct

Study sponsor and CRO wanted to include sites in trial Y where there were no raters who met the qualification criteria for participation.  The available raters were experienced with the study population but were unfamiliar with the metrics used in the study and had never participated in a clinical trial. The projected patient population for the sites was study naïve and therefore ideal for trial Y. ProPhase designed an introductory training program for the raters in order for the sites to be entered into the trial. A ProPhase trainer and project manager were assigned to the program to assist the raters and to monitor their progress. All sites completed the introductory training, joined trial Y, and received the standardized rater training with their trial peers at an Investigators’ Meeting. 

Result: The raters from the sites in question actually outperformed many of the more trial-experienced raters from other sites and countries during certification exercises.