PURPOSE: With electronic medical records (eMRs), the option now exists for clinical trial monitors to perform source data verification (SDV) remotely. We report on a feasibility study of remote access to eMRs for SDV and the potential advantages of such a process in terms of resource allocation and cost. METHODS: The Clinical Trials Unit at the Peter MacCallum Cancer Centre, in collaboration with Novartis Pharmaceuticals Australia, conducted a 6-month feasibility study of remote SDV. A Novartis monitor was granted dedicated software and restricted remote access to the eMR portal of the cancer center, thereby providing an avenue through which perform SDV. RESULTS: Six monitoring visits were conducted during the study period, four of which were performed remotely. The ability to conduct two thirds of the monitoring visits remotely in this complex phase III study resulted in an overall cost saving to Novartis. Similarly, remote monitoring eased the strain on internal resources, particularly monitoring space and hospital computer terminal access, at the cancer center. CONCLUSION: Remote access to patient eMRs for SDV is feasible and is potentially an avenue through which resources can be more efficiently used. Although this feasibility study involved limited numbers, there is no limit to scaling these processes to any number of patients enrolled onto large clinical trials.
PURPOSE: With electronic medical records (eMRs), the option now exists for clinical trial monitors to perform source data verification (SDV) remotely. We report on a feasibility study of remote access to eMRs for SDV and the potential advantages of such a process in terms of resource allocation and cost. METHODS: The Clinical Trials Unit at the Peter MacCallum Cancer Centre, in collaboration with Novartis Pharmaceuticals Australia, conducted a 6-month feasibility study of remote SDV. A Novartis monitor was granted dedicated software and restricted remote access to the eMR portal of the cancer center, thereby providing an avenue through which perform SDV. RESULTS: Six monitoring visits were conducted during the study period, four of which were performed remotely. The ability to conduct two thirds of the monitoring visits remotely in this complex phase III study resulted in an overall cost saving to Novartis. Similarly, remote monitoring eased the strain on internal resources, particularly monitoring space and hospital computer terminal access, at the cancer center. CONCLUSION: Remote access to patient eMRs for SDV is feasible and is potentially an avenue through which resources can be more efficiently used. Although this feasibility study involved limited numbers, there is no limit to scaling these processes to any number of patients enrolled onto large clinical trials.
Authors: R J Prescott; C E Counsell; W J Gillespie; A M Grant; I T Russell; S Kiauka; I R Colthart; S Ross; S M Shepherd; D Russell Journal: Health Technol Assess Date: 1999 Impact factor: 4.014
Authors: Katherine Huppler Hullsiek; Jonathan M Kagan; Nicole Engen; Jesper Grarup; Fleur Hudson; Eileen T Denning; Catherine Carey; David Courtney-Rodgers; Elizabeth B Finley; Per O Jansson; Mary T Pearson; Dwight E Peavy; Waldo H Belloso Journal: Ther Innov Regul Sci Date: 2015-03-01 Impact factor: 1.778
Authors: Elizabeth C Verna; Marina Serper; Jaime Chu; Kathleen Corey; Oren K Fix; Karen Hoyt; Kimberly A Page; Rohit Loomba; Ming Li; Gregory T Everson; Michael W Fried; Guadalupe Garcia-Tsao; Norah Terrault; Anna S Lok; Raymond T Chung; K Rajender Reddy Journal: Hepatology Date: 2020-11 Impact factor: 17.298