FDA’s Guidance Lists Best Practices for Using Electronic Systems in Clinical Trials
​[Posted on: Thursday, June 22, 2017]

This week FDA released a new guidance describing best practices for using electronic systems in regulated clinical trials and it all but confirms the already standard practice in the industry. However, the guidance will definitely help quality assurance and information technology personnel to enforce electronic hygiene. The guidance is organized in a Q&A format indicating that these questions have been raised with the Agency by users of electronic systems or have come up during FDA audits. The document covers common practical issues with using electronic systems such as eTMF, EDC, eCTMS, electronic source documents, electronic health records, mobile phones and other devices, in clinical trials. There are common themes across all areas covered, namely, that FDA expects the sponsors and contractors using electronic systems follow good electronic recording practices. All systems and devices must be secured in the most reasonable manner to assure proper usage, the credibility and integrity of the collected information must be verified, and all data elements must be attributable to individuals who created them. For all aspects, the sponsors of clinical trials are ultimately responsible to assure that the systems are working adequately and audit trails are maintained. The sponsors should follow a risk-based approach for validation, implementation, maintenance, updating, and securing systems. All personnel, including clinical investigators should be trained before asking them to use any systems or devices. For trials using patient’s own mobile devices, the sponsor only needs to assure that the subject is properly trained to not share devices and provide accurate data. Only the data captured in the electronic source documents is subject to the FDA audit; FDA does not expect the sponsor to be accountable for every mobile device used by patients to report to a given clinical trial. There are literally no surprises in the guidance. Most of these practices are already well established in the industry and are based on common sense for using electronic systems in all areas not just clinical trials. From the regulatory point of view, FDA has always followed enforcement discretion to apply 21 CFR Part 11 to electronic systems in clinical trials. The guidance does not change that. The industry should use this guidance to create checklists for best practices for using electronic systems in clinical trials.