Abstract
Background Adverse event (AE) reporting is an integral part of safety monitoring for clinical trials and standard definitions for medical AEs exist under GCP. However, public health trials in community settings present challenges for consistent safety monitoring. For studies of complex behaviour change interventions, what should be recorded may not be self-evident. Building Blocks is such a trial and is evaluating the effectiveness of a home visiting intervention (Family Nurse Partnership programme). This presentation aims to assess variability in safety reporting, and explore factors associated with nature, level and quality of reporting.
Highlights
Adverse event (AE) reporting is an integral part of safety monitoring for clinical trials and standard definitions for medical AEs exist under GCP
The nature of non-medical AEs may be especially important in some trials
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Summary
Reporting adverse events in a large community-based public health trial (building blocks): what gets reported and how does it vary?. Gwenllian Moody1*, Eleri Owen-Jones, Rebecca Cannings-John, Carolyn Wallace, Mike Robling, Julia Sanders. From 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK. From 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK. 18-19 November 2013
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