We provided comprehensive training and quality control services including all key training and materials in the rater’s language.
Sites had limited experience with study measures and clinical trial conduct. There were some sites in this study where no raters 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 this trial. The study Sponsor and CRO wanted to find a solution which would allow these sites to participate in the trial.
Stratification of Training: In addition to the existing program of initial and ongoing training, our research staff designed an introductory training program for the subset of less experienced raters in order for the sites to be allowed to participate in the trial. Our trainer and project manager were assigned to the program to assist targeted raters and to monitor their progress closely. All sites completed the introductory training, joined the trial, and received the standardized rater training with their trial peers at an Investigators’ Meeting.