Moca cognitive assessment for kids trial#
Moca cognitive assessment for kids license#

In fact, to be truly ALCOA+ compliant, paper source records should always be “available” to the study investigator even before later delivery to the site. Source documents must be dated and signed off to ensure they are compliant with ALCOA+ principles. Drawing, writing, or diagramming tasks are typically done on paper, which becomes a source document and must be stored in the participant’s study file this is not practical under remote administration conditions. The clinician can observe the participant’s behaviors and task completion. Under traditional administration conditions, the clinician and participant sit facing each other. Telephone-based visits can accommodate some cognitive COAs, but many validated and standardized examples commonly used in clinical trials include a combination of clinician interview and participant performance tasks (e.g., drawing shapes, completing diagrams, or behavioral tasks).

Moca cognitive assessment for kids trial#

However, these “less-complex” assessments may not satisfy the needs of the trial or be suitable for the population. There are several less complex cognitive COAs that more easily translate to a remote environment and indeed some are specifically designed for this purpose.

Moca cognitive assessment for kids license#

Another consideration is whether the assessment license holder will allow it to be performed remotely. When choosing a cognitive assessment, it is important to consider whether the assessment is both appropriate to the population being investigated and that it will address the hypothesis and fulfill the criteria for the trial estimand. These cognitive COAs are more difficult to administer remotely and require creative solutions to accommodate a cognitively-impaired population. However, some cognitive assessments-such as the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment(MoCA)-require complex interactions between the participant and clinician to assess dementias and other neurocognitive disorders. The use of electronic methods to capture clinical outcomes assessment (COA) data has facilitated this pivot, as has the use of telehealth applications. Rather than bringing participants into sites, allowing them to participate from the safety of their own homes by leveraging remote data-collection methods placed participant preference at the center of the research effort and positively impacted participant engagement. While the COVID-19 pandemic has undoubtedly catalyzed the adoption of more flexible data- collection approaches within clinical trials, this has been the direction of travel for some time.