?:definition
|
-
The textual representation of the study objective. EXAMPLE(S): The objective of the analysis is to evaluate the efficacy of study treatment versus placebo. The Alzheimer\'s Disease Assessment Scale - Cognitive Subscale, total of 11 items [ADAS-Cog (11)] and the Video-referenced Clinician\'s Interview-based Impression of Change (CIBIC+) will serve as the primary efficacy instruments. Efficacy will be determined by testing for a statistically significant relationship between the change in both the ADAS-Cog (11) and CIBIC+ scores, and drug dose (0, low dose [54 mg], and high dose [81 mg]). OTHER NAME(S): NOTE(S): The example above makes reference to content from more than just the StudyObjective class, rather also from classes closely related to it. However, in prose presentation, this is common practice. See BRIDG GForge Tracker #30649 and #31401.
|