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Initial Considerations
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This guide describes the process & steps needed to request a REDCap for 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
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The Process
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Participants View & Usage(Use this section when appropriate)
Additional Considerations
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