ICH-GCP guidelines have provided international ethical, scientific, quality standards for designing, conducting, recording, and reporting of clinical trials, and are hugely popular in the region. Recent revisions to its guidance; ICH-GCP; E6 (R3) have brought significant changes in both structure and content from its predecessor, affecting every…

Multisite trials that randomize individuals (e.g., students) within sites (e.g., schools) or clusters (e.g., teachers/classrooms) within sites (e.g., schools) are commonly used for program evaluation because they provide opportunities to learn about treatment effects as well as their heterogeneity across sites and subgroups (defined by moderating…

This secondary analysis of data from a randomized control trial of an early mathematics intervention, ROOTS, explored whether patterns of intervention response were best categorized by the typical response/non-response binary or a more complex framework with additional response profiles. Participants included kindergarten students at risk for…

Social-emotional learning (SEL) programs are frequently evaluated using randomized controlled trial (RCT) methodology as a means to assess program impacts. What is often missing in RCT studies is a robust parallel investigation of the multi-level implementation of the program. The field of implementation science bridges the gap between the RCT…