Table 1.

Adverse event reporting challenges and potential solutions

Challenges	Solutions
Variation in training and background education on AE reporting	Increase availability of training regarding AE reporting for clinical research associates Provide training for clinicians on CTCAE and documenting AEs in the chart Provide additional guidance on interpreting AE definitions to account for variation in medical knowledge
AE reporting is labor intensive	Implement automated extraction of electronic health record data to identify AEs, for example, a tool such as ExtractEHR Incorporate trigger tools and alert systems into the EHR so that clinicians, CRAs, and research nurses are alerted to potential AEs that need to be reported Create an automated system to move data from the EHR into the clinical trial data capture system Limit the scope of AEs required to be collected on clinical trials
Complexity of the CTCAE	Streamline AE definitions to reduce potentially overlapping definitions and subjectivity in definitions Provide guidance about comprehensiveness of AE reporting (i.e. to report the syndrome and the individual symptoms or to report just the syndrome) Add more pediatric-specific guidance for AE definitions
Current AE reporting does not provide a complete understanding of AE experienced	Incorporate methods to capture duration of AEs rather than only the highest grade, such as ToxT Include patient-reported outcome measures into clinical trials to supplement clinician-identified AEs

AE, adverse event; CRA, clinical research associate; CTCAE, Common Terminology Criteria for Adverse Events; EHR, electronic health record; ToxT, toxicity over time