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Innovative Approach to Study Management: Ensuring Regulatory Compliance in a Paperless Environment
Electronic data collection and management has become the industry norm in human research. There is minimal debate as to whether implementing electronic processes for study management is optimal compared to paper-based modalities. However, the process of converting from paper to electronic continues to raise questions and concerns. Topping the list is “perceived” implementation cost. Next is having the capacity (FTEs) to sustain the review of increased documentation flow an electronic system may bring.
Despite these concerns, there continues to be a trend towards electronic study management. This trend exists amongst academic and commercial IRBs and extends to investigators who maintain electronic records. As a result, compliance units including Harvard Chan School’s Quality Improvement Program (QIP) has customized 3 electronic study management platforms namely Box, Redcap, and SharePoint, resulted in an increase efficiency of the monitoring process.
All three systems have a nominal to no fee associated with them. Each includes customizations to facilitate monitoring. In particular, Box was designed with a robust internal communication system that features assigning monitoring tasks to users, tracking task completion status, and maintaining a communication log. QIP made additional enhancements to include customized CRFs, which can limit queries associated with poorly designed CRFs (e.g. missing signature lines, required data points, etc.). Other customizations include built-in regulatory tips/best-practices and logs and checklists to assist in ensuring compliance. These features were added in response to both FDA and NIH guidance on taking a risk-based approach to monitoring. Use of these platforms has resulted in less onsite monitoring time, shorter monitoring reports, and reduced follow-up to confirm implementation of corrective actions.
Through trial and error, QIP’s approach has proven that a one size (system) may not fit all, but in the end innovative change is vital to sustaining compliance.