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Initial Considerations

The concept of data security and compliance is a combination of hardware and software, as well as user processes and procedures. The FDA has issued guidelines to provide recommendations to clinical investigators and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. The guidelines are intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission. This article is meant to help University of Utah researchers understand how REDCap is configured to support their studies in a protected and compliant environment.

The University of Utah REDCap instance is supported and maintained by the Center for Clinical and Translational Science (CCTS) in the Center for High Performance Computing Protected Environment. The system is HIPAA compliant and deployed in the University of Utah Downtown Data Center where physical and network access is tightly controlled 24/7/365. Data is backed up nightly. Additionally, user and role-based permissions provide granular management of access to data records and functions

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. Reporting and audit controls follow HIPAA standard best practices

What is 21 CFR Part 11?

Title 21 Code of Federal Regulations governs Food and Drugs. Part 11 is the Food and Drug Administration (FDA) guidelines that sets forth the criteria under which the Agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. This regulation, which applies to all FDA program areas, was intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to protect the public's health.

Code of Federal Regulations Title 21
Guidance > Part 11, Electronic Records; Electronic Signatures — Scope and Application
Guidance > General Principles of Software Validation
Guidance > 2007 Guidance for Industry Computerized Systems Used in Clinical Investigations
Guidance > 2013 Guidance for Industry: Electronic Source Data in Clinical Investigations
Electronic Submissions Guidance > Sortable listing of Electronic Submissions Guidances

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