REDCap bits

To access Lifespan’s Instance of REDCap:  https://redcap.lifespan.org/redcap/

Is the University of Rhode Island your primary affiliation and you’d like to request the use of REDCap? Please fill out this service request form to gain access to URI’s instance of REDCap.

Lifespan REDCap and CFR 21 Part 11 Compliance

CFR 21 Part 11 Compliance is not a feature that can be turned on, but rather a process that a project needs to go through to ensure traceability and data integrity. In general, each project has system level compliance requirements AND project level compliance requirements.

  • Documentation on System Level data integrity can be found below.
  • Project Level Compliance must be determined by each PI on a project level basis. In general REDCap has tools to make this easy. Credentialed user logins, project logging, e-signatures/locking management, field comment log, data resolution workflow. However, each project needs to have a documented procedure, training and validation for its intended use.

To learn more about CFR 21 part 11, regularly updated information can be found here. To learn more specifically about CFR 21 part 11 compliance in REDCap, both RISC and ITHS have helpful explainers. A loose example of what a compliance document could look like can be found here.

REDCap Citation for Lifespan Security and Infrastructure:

Data will be collected and managed using the REDCap electronic data capture tools hosted at Lifespan’s Department of Information Services. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources.

The Lifespan REDCap infrastructure is composed of two-production and two-test servers, all of which are backed up daily. All data in encrypted in transit and at rest. Backups occur every night and are retained for 35 iterations. In addition, long-term backup occurs monthly and is retained for 7 years offsite. REDCap data storage servers are located behind a firewall, are virtual, and are protected by multi-layered, enterprise-level security (monitored 24/7/365). All hardware resides in the corporate data center, which is physically secure, with triple-redundant power. This architecture was designed by network engineering and approved by IS Security

Reference: Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. Conde, Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81. (http://www.sciencedirect.com/science/article/pii/S1532046408001226)

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