Adverse event reporting and harms {22}
death
ADVERSE EVENTS, ADVERSE EVENT, EVENTS, EVENT
Monitoring and reporting of adverse events will be conducted from the time of consent to trial entry until the end of the trial. Adverse events and harms will be collected non-systematically, i.e., through spontaneous reporting of events. Research personnel will be asked to report unanticipated problems and adverse events, including serious adverse events such as an important medical event, hospitalization, or death of a mother or of a child of an enrolled mother, within 24 h of learning of the event. If known, the reason for the event should also be reported. The principal investigator, who is a pediatrician, will review the event within 24 h. The purpose of the review will be to assess if there is any reason that the event can be considered attributable to the study’s intervention. If the study is considered a causative factor, the report will be forwarded to the other principal investigator. The principal investigators will then determine the appropriate response through consultation with appropriate individuals. Adverse events will be documented in the participant file and reported to the appropriate IRB. It is believed that rarely would the study be considered a possible cause, but the establishment of the review procedure should assure that harm potentially attributable to the study is not missed and that any identified harm is addressed and avoided going forward. The review procedures developed for this study consist of weekly meetings with the opioid treatment program clinical team to review specific issues that were identified in the group visits. Issues such as maternal substance use or relapse, child safety concerns, and indications for child protective service involvement as well as housing, family safety, and other concerns are addressed with the team and clinical therapists, social workers, navigators, or peer support specialists are engaged to address issues.