Evaluation of a REDCap-based Workflow for Supporting Federal Guidance for Electronic Informed Consent.

Adoption of electronic informed consent (eConsent) for research remains low despite evidence of improved patient comprehension, usability, and workflow processes compared to paper. At our institution, we implemented an eConsent workflow using REDCap, a widely used electronic data capture system. The goal of this study was to evaluate the extent to which the REDCap eConsent solution adhered to federal guidance for eConsent. Of 29 requirements derived from sixteen recommendations from the United States Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA), the REDCap eConsent solution supported 24 (86%). To the best of our knowledge, this is among the first studies to evaluate an eConsent approach's support for federal guidance. Findings suggest use of REDCap may help other institutions overcome barriers to eConsent adoption, and that OHRP and FDA expand guidance to recommend eConsent solutions integrate with enterprise clinical and research information systems.

Implementing a Clinical Research Management System: One Institution's Successful Approach Following Previous Failures.

Clinical research management systems (CRMSs) can facilitate research billing compliance and clinician awareness of study activities when integrated with practice management and electronic health record systems. However, adoption of CRMSs remains low, and optimal approaches to implementation are unknown. This case report describes one institution's successful approach to organization, technology, and workflow for CRMS implementation following previous failures. Critical factors for CRMS success included organizational commitment to clinical research, a dedicated research information technology unit, integration of research data across disparate systems, and centralized system usage workflows. In contrast, previous failed approaches at the institution lacked a mandate and mechanism for change, received support as a business rather than research activity, maintained data in separate systems, and relied on inconsistent distributed system usage workflows. To our knowledge, this case report is the first to describe CRMS implementation success and failures, which can assist practitioners and academic evaluators.