ch13

Psychology in Action

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On any given day, I have on average 8-10 clinical research studies simultaneously being conducted both within the United States and globally. Some of these studies are enrolling; others are still in the design phase. It is my job to ensure that each one of our psychiatric studies has the appropriate diagnostic and assessment measures, that each scale has been appropriately researched for copyright permission, licensing, administration, and references, and that our research sites are properly trained on the psychiatric measures. I also employ the services of various rater-training companies to train raters at clinical research sites across the United States and around the world. It is my job to provide clinical oversight and administrative direction to the vendors, as I am responsible for managing the budgets and payments as well. I work with the rater-training vendors to co-design the training curriculum, approve the design and implementation of all training videos, slides, and all correspondence that goes between the vendor and the sites. I attend the Investigator Meetings to supervise the rater training by the vendor, and I also train the raters and other clinical staff on various psychiatric scales. Most recently, I had the opportunity to train raters in Mexico City. Non-U.S. studies are a great challenge and truly can be the most rewarding. Today I am working on two different research studies in the design phase, and I have seven which are actively enrolling. I arrive at the office around 9:00 a.m. and retrieve three messages, two of which involve rater issues at sites for two different studies. The first call I return is to a site working on one of the depression trials. They are confused as to which version of the Structured Clinical Interview for DSM-IV (SCID) they are to use. I explain that they are to use the version that was sent to them in the rater-training manual. They tell me they never received it. I tell them that my secretary will send one overnight to them. My second call to return is not as easy. Our rater-training vendor informs me that both of the raters at the East Coast site both failed terribly on their training. It turns out that they did the training together, instead of separately, so their scores are identical – identically wrong. I suggest that we issue a new training program to both raters and advise that they do the training separately along with Instructor’s Resource Guide                              Chapter 13                                         Page   151
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providing the raters with remediation to note their errors so they are not reproduced on the second training program. While this seems to be a good solution, this site has no other raters, thus their site is further delayed from beginning enrollment and will have a slight impact on the overall study enrollment and timelines even though we have ten sites enrolling with eight more scheduled to enroll by next month.
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