Data and safety monitoring board
ADVERSE EVENTS, PCP
The study’s principal investigator (JAF) will have overall responsibility for the Data Safety and Monitoring Plan and for participant safety monitoring. As we are studying only the pediatric-implementation of MTM, an evidence-based practice recommended and widely provided for adult and geriatric enrollees with polypharmacy, the risks to human subjects are minimal, Furthermore, any medication-related optimizations made as part of the pMTM intervention are implemented based on joint decision making between the patient, parent, and the PCP during the routine clinical visit. Although minimal risks to human subjects are anticipated and a formal data safety monitoring board is not required, we will take robust precautions to monitor study participants for signal of adverse events or unanticipated problems during the study according to AHRQ requirements.