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The REDCap Core maintains a 21 Part 11 compliant REDCap server. This server has dedicated procedures, testing, and documentation to maintain 21 Part 11 server-level compliance. However, to be fully compliant with 21 Part 11, the study team is required to maintain project-level compliance. This means...

REDCap account holders are required: To disclose, receive, transmit, maintain or create data consistent with the electronic data collection policies of BILH and the requisite data use agreement. To collect such data pursuant to the Privacy Regulations and the Security Regulations under the Health...

REDCap Accounts for BILH Employees BILH employees at all sites (including BIDMC, Exeter, Joslin, Lahey and Mt. Auburn users): Accounts do not need to be requested for employees: REDCap access is built-in to all BILH employee accounts. New users may log in to any REDCap server using the blue 'BILH...

The Statement of Compliance for the REDCap eConsent and Validated Research servers is available for download below.

Username/Password Issues: Use the right Login button: BILH users must use the blue 'BILH User Login' button. External users, from other institutions, must use the green 'Local REDCap Login' button. Try using a private browser window: Most modern web browsers have a "private browsing" mode- sometimes...

What is Part 11? The Code of Federal Regulations (CFR) provides the rules and regulations established by the Food and Drug Administration (FDA) for electronic records and electronic signatures, these are also referred to as 21 CFR Part 11 or Part 11 compliance. 21 CFR Part 11 describes the...