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e-Consent Instruments

  1. Build your consent instrument to includeevery component that has been approved on your IRB consent within the signature block, such as name, DOB, and signature. This includes specific discrete fields captured in your consent document ie, (genetic result storing, f/u for future studies, etc).

    1. Include a descriptive text ‘placeholder’ field for the consent form.

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    2. Ensure the consent date field has a minimum and maximum validation set to ‘today’.

  2. Enable the consent instrument as a survey. All electronic consent instruments MUST be enabled as surveys.

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  3. Enable the e-Consent framework by selecting the e-Consent and PDF Snapshots tab.

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    1. +Enable the e-Consent Framework for a survey.

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      1. Select your consent instrument.

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      2. Configure your settings. The ability to edit responses MUST be left unchecked and name and signature fields MUST be designated. You may optionally add the custom tag/category for the PDF footer, designate date of birth, and/or add a custom label for the PDF header.

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    2. + Add consent form.

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      1. Enter the version number in the Consent form version field.

      2. Select the descriptive field for placement of consent form.

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      3. If configuring specific consent forms for DAGs or multiple languages, make those settings here.

      4. On the Consent Form (Inline PDF), Choose File to upload a PDF of your consent document.

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e-Consent surveys can be sent through Automated Survey Invitations (ASI) or opened as a survey in the REDCap project by a coordinator and handed over to the participant.

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Version Control

When informed consent documents are updated, it is important to track new versions. To update consent documents in a project, navigate to the e-Consent and PDF Snapshots from the Online Designer.

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  1. + Add consent form.

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    1. Enter the next version number in the Consent form version field.

    2. Ensure the descriptive field for placement of consent form is selected.

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    3. If configuring specific consent forms for DAGs or multiple languages, make those settings here.

    4. On the Consent Form (Inline PDF), Choose File to upload a PDF of your newest versioned consent document.

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Note

NOTICE: After clicking the "Add new consent form" submit, the consent form will GO LIVE IMMEDIATELY on the e-Consent survey.

Additionally, make sure to update Automated Survey Invitations (ASIs) or modify Alerts depending on your distribution method.

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Old versions of consent forms can be viewed by selecting “View all versions”

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