In this role, LEADs provide rater training and determine readiness for certification on clinical assessment administration in local languages. LEADs coach raters on clinical interviewing skills and standardized test administration and scoring practices via write-ups of rater performance feedback, and live video training teleconferences. Cogstate coordinates all administrative-, scheduling- and tracking aspects of rater training assignments.
Roles within the LEADs Network
Based on individual LEADs’ availability and the needs of the studies Cogstate is supporting, LEADs have opportunities to take on distinct roles within the network. LEADs can choose to take on different roles at different times based on their interests and availability. Formal onboarding, training, and certification for the LEAD role is provided. All aspects of LEAD training can be completed remotely.
LEADs fill the following roles
EXPERT TRAINERS Train and certify clinical trial raters to administer study scales
CENTRAL MONITORS Evaluate, coach, and mentor raters to ensure correct scale administration
In this role, LEADs review completed neuropsychological test batteries to ensure accuracy in administration and scoring, contributing to the overall success of a clinical trial. They review clinical response forms from local sites and offer feedback to site raters via email and telephone communications. They also liaise with- and offer support to personnel at local sites in the local language. This role is highly flexible, and LEADs may conduct reviews at any convenient times within a specified time frame.
CENTRAL RATERS Perform clinical assessments via telehealth
In this role, LEADs directly administer cognitive and clinical outcome measures via telehealth to patients enrolled in clinical trials. In contrast to the traditional approach where raters are dispersed across many clinical research sites, Central Raters are uniformly and regularly trained and calibrated to increase reliability, standardizations, and scoring accuracy in clinical trials. Central raters undergo close performance surveillance and regular recalibration to reduce rater drift. In addition, operational training on workflows, electronic platforms, and telehealth modalities is provided. Cogstate facilitates the administrative aspects of coordinating schedules and other elements. The schedule tends to be a bit more rigid as there is coordination with sites and patients.
CULTURAL / LINGUISTIC CONSULTATION Provide guidance on scale selection or translation
In this role, LEADs provide guidance on cultural-linguistic validity of scale selection and translation. Since cognitive scales are mostly developed for use in English-speaking, Western contexts, the use of translated tests with patients in other cultural-linguistic groups can be problematic if not accurately adapted. LEAD input into scale selection, translation, and localization helps ensure high-quality data is gathered from cognitive assessments in global trials.