Data and safety monitoring in social behavioral intervention trials: The REACH II experience Academic Article uri icon

Overview

MeSH Major

  • Alzheimer Disease
  • Caregivers
  • Clinical Trials Data Monitoring Committees
  • Social Behavior

abstract

  • Overall, the REACH II experience demonstrates that existing guidelines regarding safety monitoring and adverse event reporting pose unique challenges for social/behavioral intervention trials. Challenges encountered in the REACH II program included defining and classifying adverse events, defining "resolution" of adverse events and attributing causes for events that occurred. These challenges are highlighted and recommendations for addressing them in future studies are discussed.

publication date

  • June 9, 2006

Research

keywords

  • Academic Article

Identity

Language

  • eng

PubMed Central ID

  • PMC1484572

Digital Object Identifier (DOI)

  • 10.1191/1740774506cn136oa

PubMed ID

  • 16773953

Additional Document Info

start page

  • 107

end page

  • 18

volume

  • 3

number

  • 2