Version: 12
Who needs to follow 21 CFR part 11 compliance?
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Electronic Consent: in the scope of REDCap, electronic consent refers to the electronic capture of a ‘wet' signature from a participant using the e-consent framework. This requirement covers the ‘Electronic Signature’ definition found in the FDA part 11 regulations.
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Electronic Signature (E-Signature): in the scope of REDCap, an E-signature refers to the individual verifying the data being captured electronically, digitally signing, and authenticating their identity. This requirement covers the ‘Digital Signature’ definition found in the FDA part 11 regulations.
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View the FDA Title 21 Chapter I Subchapter A Part 11 regulations here.
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Security features that limit user access and their privileges must be in place. Some examples of these security features include making sure users have unique usernames and passwords, being able to detect and prevent unauthorized system access, and locking compromised accounts, and utilizing the Data Resolution Workflow.
The three primary tools for enforcing limited system access:
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User Roles It is up to the discretion of the project PI in conjunction with the study team to set up User Rights & Rolesin a project. In order for a study to be Part 11 Compliant, project sponsor / investigator roles and responsibilities must be clearly articulated to provide awareness to sponsors and investigators of responsibilities to adequately conduct clinical trials. It is important to separate roles and their designated rights in each project. The following examples would meet Part 11 compliance for separation of concerns: Administrator Auditor / Monitor Data Entry Analyst Principle Investigator Study Coordinator
 Note: The eConsent REDCap Template includes 5 unique roles. Please add additional or remove roles as needed for your project needs. | Info |
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Data Resolution Workflow: Only those that have the ‘User Rights’ privilege can provide access privileges to the Data Resolution Workflow. By default, only the ‘Principal Investigator’ & ‘Study Coordinator’ will have the ‘Open, close, and respond to queries’ privilege, all other user roles will will have ‘No Access’. The study team must enable the desired privileges to this function for each user/role as needed based on study operations and procedures.  Image Added |
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Relevant Resource: https://utahctsi.atlassian.net/servicedesk/customer/portal/3/article/276988105?src=543000090
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