title: An adverse event capture and management system for cancer studies.
abstract: BACKGROUND
  Comprehensive capture of Adverse Events (AEs) is crucial for monitoring for side effects of a therapy while assessing efficacy. For cancer studies, the National Cancer Institute has developed the Common Terminology Criteria for Adverse Events (CTCAE) as a required standard for recording attributes and grading AEs. The AE assessments should be part of the Electronic Health Record (EHR) system; yet, due to patient-centric EHR design and implementation, many EHR's don't provide straightforward functions to assess ongoing AEs to indicate a resolution or a grade change for clinical trials.
  
  
  METHODS
  At UAMS, we have implemented a standards-based Adverse Event Reporting System (AERS) that is integrated with the Epic EHR and other research systems to track new and existing AEs, including automated lab result grading in a regulatory compliant manner. Within a patient's chart, providers can launch AERS, which opens the patient's ongoing AEs as default and allows providers to assess (resolution/ongoing) existing AEs. In another tab, it allows providers to create a new AE. Also, we have separated symptoms from diagnoses in the CTCAE to minimize inaccurate designation of the clinical observations. Upon completion of assessments, a physician would submit the AEs to the EHR via a Health Level 7 (HL7) message and then to other systems utilizing a Representational State Transfer Web Service.
  
  
  CONCLUSIONS
  AERS currently supports CTCAE version 3 and 4 with more than 65 cancer studies and 350 patients on those studies. This type of standard integrated into the EHR aids in research and data sharing in a compliant, efficient, and safe manner.
authors.forename: Alex
authors.initials: A
authors.lastname: Lencioni
authors.forename: Laura
authors.initials: L
authors.lastname: Hutchins
authors.forename: Sandy
authors.initials: S
authors.lastname: Annis
authors.forename: Wanchi
authors.initials: W
authors.lastname: Chen
authors.forename: Emre
authors.initials: E
authors.lastname: Ermisoglu
authors.forename: Zhidan
authors.initials: Z
authors.lastname: Feng
authors.forename: Karen
authors.initials: K
authors.lastname: Mack
authors.forename: Kacie
authors.initials: K
authors.lastname: Simpson
authors.forename: Cheryl
authors.initials: C
authors.lastname: Lane
authors.forename: Umit
authors.initials: U
authors.lastname: Topaloglu
mesh_terms: D003625:Data Collection / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis*; D006801:Humans; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D014481:United States