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Researchers must use the CTSI e-Consent ? instrument template found in the REDCap CTSI FDA e-Consent and EDC ? project template. Fields may be adjusted as needed, pending REDCap admin approval.
Electronic consent instruments MUST be enabled as a survey, with Auto-Archiver + e-Consent Framework enabled in the survey settings for the instrument. The ability to edit responses MUST be unchecked.
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Signed electronic records must include:
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For more detailed instructions on how to implement e-consent in REDCap, see the e-Consent Knowledge Article Links to an external site..
Assent and Parental Permission Forms
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