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Initial Considerations

This guide describes the process & steps needed to request a REDCap, CFR Part 11 Validated project.

Part 11 Compliance enforces provisions which requires that:

  • Study personnel develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks.

  • establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures

The Process

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Participants View & Usage(Use this section when appropriate)

Additional Considerations

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