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Show Using the Epic EMR for Research Documentation Rachel Kingsford, MS, CCRP; Leanne Lujan, BS, CCRP; Lindsay Carpenter, MSW, CCRC; Sally Fairbairn, BS, CCRP; Susan Sharry, BS, CCRP; Karthik Sonty, BS, CCRP; Jessica Moehle, BS, CCRP; Theresa L. Werner, MD Huntsman Cancer Institute at the University of Utah BACKGROUND RESULTS CONCLUSIONS Accurate and timely documentation of research data are critical for ensuring patient safety and data integrity. Leveraging the electronic medical record (EMR) system for capture of research documentation has allowed the Huntsman Cancer Institute (HCI) Clinical Trials Office (CTO) to produce contemporaneous research documentation in an electronic system including audit trail and signature capabilities. Availability of research records in the EMR is critical for continuity of care and patient safety. • Investigators are supportive of the process as it allows: Electronic signature at the convenience of the investigator Availability of research information along with clinical information More organized information • Sponsors are also receptive of the process and find the formatting of adverse events especially useful. Use of the EMR for research documentation is a viable alternative to spreadsheets and paper logs. This process has been well-received by investigators and sponsors alike. Training of staff and investigators on the process outlined in the SOP has been critical for success. FUTURE PLANS Ongoing training and re-evaluation of the process is essential for continued success. Limitations of the EMR (such as with addenda) have required navigation and modification of the SOP. The use of electronic research documentation will better position the HCI CTO for future paperless research charts. METHOD • HCI CTO Leadership completed a thorough review of the EMR features and capabilities. • Leadership then drafted an SOP (standard operating procedure) for the EMR research note process including the following elements: Creation of a departmental research note template SmartPhrase Areas to leave placeholders (denoted by three asterisks) for efficient entry of information required from the investigator (e.g., adverse event attribution, clinical significance of labs, etc.) Investigator attestation of review and electronic signature Figure 1. Sample adverse event table Figure 2. Sample lab table demonstrating threeasterisk placeholder Acknowledgements: font for text. This is Arial 32 point font for text. You can decrease font size as needed, but not less than 24 point font. This is Arial 32 point font for text. |
