We provided comprehensive training and quality control services, as well as one-on-one training in interview technique, providing all key training and materials in the rater’s language.
Regulatory authority requested additional measures of adverse events; no measures were available During the course of regulatory submission, an international regulatory agency requested that the protocol include a measure of a specific subset of possible adverse events. Since we were engaged on the project, the Sponsor asked our Research and Training Development team for scale recommendations. Some well-validated scales that could be appropriate were suggested, but rejected by regulators as not being sufficiently specific.
Customized scale development; in this case, we created an introductory program for the subset of raters with less experience, adding it to the existing program of initial and ongoing training. This allowed the sites to participate in the trial. A specified trainer and project manager from us were assigned to the program with instructions to assist the less experienced raters and monitor their progress often. Each site completed the introductory training and was able to join the trial and receive standardized rater training with their trial peers at an Investigators’ Meeting