Use of EDC Systems to Monitor Informed Contents Remotely

Publication Type
Conference Paper
Year of Publication
2016
Authors
Case, A; Shmueli-Blumberg, DB; Yesko, L; Lindblad, R; King, D; Wright, M; Jeffries, B
Secondary
Society for Clinical Trials (SCT) 37th Annual Meeting
Date Published
05/2016
Location
Montreal, Quebec, Canada
Keywords
Informed consent; Monitoring; remote monitoring
Abstract
Careful monitoring of Informed Consent Forms (ICFs) is vital for the protection of the rights and welfare of human participants in clinical trials. Traditionally, ICFs are reviewed during on-site monitoring visits, in large numbers (depending on enrollment rate) and usually 3 – 6 months after the enrollment visit has occurred. With increased technological sophistication in the design of Electronic Data Capture (EDC) systems, information that is electronically submitted can be more securely controlled by using mechanisms, such as encrypting data, restricting access to view data, and automatically removing the data after review. These system advancements allow for review of ICFs through the EDC system, thereby improving timeliness of review and feedback to the clinical sites, and allowing more time while onsite to address other critical issues. The Emmes Corporation, which serves as the Data and Statistics Center (DSC) and the Clinical Coordinator Center (CCC) for the National Institute on Drug Abuse (NIDA)-sponsored National Drug Abuse Treatment Clinical Trials Network (CTN), has implemented a module in the EDC system that allows for controlled review of uploaded consents/assents and other regulatory documents that require a participant signature or other PHI (e.g., medical releases). The benefits, drawbacks, and requirements to implement this process will be discussed including the technical set up, the enhanced security features, training of site and monitoring staff, integration of the remote review into the monitoring plan, and the IRB review processes.