Case-based evaluation of a regional health information exchange for remote source data verification: workflow risk analysis and regulatory requirement mapping
Authors:
Masatoshi Tanigawa
(Kagawa University)
,
Sachiko Muguruma
(Kagawa University Hospital)
,
Hiroaki Nishizawa
(AiFront Corporation)
,
Seigo Sogo
(Independent Clinical Operations Consultant)
,
Kennichi Nakano
(Bunzen Co., Ltd.)
,
Hideto Yokoi
(Kagawa University Hospital)
Abstract
This is an accepted article with a DOI pre-assigned that is not yet published.
Introduction: Health information exchanges may offer infrastructure for remote source data verification in clinical trials, but their suitability for regulated use has not been systematically evaluated, and no generally accepted framework exists for such evaluation.
Objectives: Using Kagawa Medical Information eXchange Reborn as a case example, we assessed the secondary use of a regional health information exchange for remote source data verification and examined how such evaluation can be conducted through workflow-level risk assessment and system-level requirement mapping.
Methods: We structured the end-to-end workflow and applied a two-layer approach consisting of failure mode and effects analysis to identify operational risks and mapping of system functions to requirements for electronic data used in regulated clinical trials.
Results: The workflow comprised 57 steps and yielded 109 risks, including 52 human or operational risks and 57 technical or system-related risks. Twelve human or operational risks were high priority and addressed through procedural controls, whereas no technical or system-related risks required corrective action. Of 37 requirements, 26 were met and 11 were not applicable.
Conclusions: The infrastructure was technically robust, whereas the main challenges concerned operational and organizational risk management. The proposed approach may also support evaluation of other healthcare information systems adapted for clinical trial use.
Keywords: Manage Clinical Research Data