ePharmaSolutions believes that the most effective rater training programs are clinically driven and protocol-specific. Such programs maximize the educational value of the training and optimize the accuracy of the acquired data. Our study-specific rater training projects take into account all relevant aspects of the targeted indication, the population under study, the countries in which the trial will be implemented, the trial design, and the chosen endpoints. This allows the program to be tailored to fit both the raters and the protocol specific details. From the initial review of the protocol and conversations with sponsor teams, through the entire data monitoring process, ePharmaSolutions' clinicians are intimately involved in all aspects of the rater training programs.

The identification of appropriate, adequately credentialed raters for the study is critically important. The ePS RaterSelector survey allows the ePharmaSolutions clinical team and the sponsor project team to carefully examine the potential raters for the study in question. This tool gathers rater credential and experience information.

ePharmaSolutions has trained raters via onsite Investigator Meetings, online meetings, individualized site trainings, and online via our workspaces. We recommend a combination of didactic and interactive video-based training. The use of an ARS system stimulates discussion among participants at meetings and facilitates the exchange of ideas and scale or indication experience between the clinical researchers.

Rater certification generally involves documented participation in the training program, scale-specific scoring proficiency, and applied skills training. Scoring proficiency is generally performed by requiring raters to score video-taped interviews. In the event that a rater does not demonstrate adequate scoring proficiency, he is remediated by an ePS clinician. Frequently, he is then permitted to view and score a second video-taped interview to demonstrate scoring proficiency. When a rater fails to demonstrate adequate scoring on the second video, the situation is brought to the attention of the sponsor, and the ePS clinician will make a recommendation regarding the advisability of allowing the rater to rate in the study. This considered recommendation takes into account all the information that the clinician has regarding the rater and his/her experience with the indication and the primary outcome measure.

In order to better approximate the actual rating process, we are excited to offer our Applied Skills Training/Assessment Program. This option addresses the raters’ ability to conduct clinical interviews and administer specific scales. Applied Skills Training is conducted in a workshop format where 10-15 raters meet with a subject matter expert and have the opportunity to interview an actor specifically trained for this purpose. Raters who are not able to be present at the IM are asked to provide video or audio tape of an interview for our review.

ePS is proud of our global rater training presence. We have trained raters in over 22 languages either with native speaking SMEs in breakout rooms at the Investigator Meetings, or via UN style simultaneous translations, and/or translated transcripts of training materials and video subtitling. Non-english speaking raters do not present a major obstacle to good training. ePS has provided translated scale and training materials in numerous languages. While many international raters may have a working knowledge of the English language, they do not usually interview clinical trial subjects in English.

Our Results
Once the training has been completed and the raters are at their sites evaluating subjects, do they continue to administer and score the outcome measures as they were taught during the training program? Rater drift certainly does occur. An experienced rater may have been administering or scoring a given scale for 20 years in an erroneous fashion. Although that rater may have understood the error, and altered it during the immediate post-IM period, he may slip back into his old habits. New, less-experienced raters may become confused or inadvertently begin to make errors with the more complicated scales. ePS clinicians believe that it is important to watch the incoming data for signs of administration errors so that raters having difficulty may be recalibrated before they influence the data significantly. Our Data Monitoring services are provided to give sponsors the security of knowing that someone is monitoring rater performance in an ongoing fashion. The ePS DM system allows clinicians to monitor instrument scores and correlations between the scores on different instruments to be certain that there is consistency. When the threshold for intervention is met, an ePS clinician calls the rater and engages him or her in a discussion of the scoring or data inconsistencies from the previous visit or within the current visit. ePS clinicians frequently give individualized scale or indication reviews to raters whose scores flag in our Data Monitoring system.

Finally, ePS takes pride in the quality of the services that we provide. We have a rigorous level of QC for every aspect of our Rater Training. We are proud to report that we have had a significant number of sponsor audits with no major findings reported by the auditors.

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