G04 - Expectations for the Use of Electronic Systems to Conduct Clinical Trial Activities and Considerations for IRBs: Perspectives From Regulators and Institutional Review Boards

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FDA regulations under 21 CFR part 11 are specifically intended to help ensure that the electronic records and data are trustworthy and reliable. In addition, the appropriate use of electronic systems in clinical trials is an important component of good clinical practice (GCP). Compliance with FDA regulations and GCP quality standards provide public assurance that the rights, safety, and welfare of study participants are protected and that the clinical trial data and information are credible. In this session, FDA staff will provide an overview of part 11 regulations, including enforcement discretion related to part 11 compliance, and recently published guidances related to good clinical practice and the use of electronic systems in clinical trials. Presenters will also discuss considerations for applying risk-proportionate approaches to the management of electronic systems used in clinical trials that are relevant to IRB activities for FDA-regulated research.