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Electronic consent instruments MUST be enabled as surveys, with Auto-Archiver + e-Consent Framework enabled in the survey settings for the instrument. The ability to edit responses MUST be left unchecked. Enter the version number in the e-Consent version field, and you may optionally add the type in the e-Consent type field.
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The consent date field has a minimum and maximum validation set to ‘today’.
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When participants are under the age of 18, a parent must also sign a parental permission survey. In the case where participants are under 7 years old, only the parental permission survey is needed. This survey does not require the participant's signature, but requires the participant's name, date of birth, parent(s)/guardian(s) name(s), parent(s)/guardian(s) signature(s), and date signed.
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Version Control
When informed consent documents are updated, it is important to track new versions. In the File Repository in the PDF Survey Archive folder, you will see all signed e-Consent documents and their versions (and optionally entered types).
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Follow the below instructions to add a new version of consent to your project.
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Copy the consent instrument, and rename it with the version number appended and suffix _v2 added to variables. In the survey settings, make sure to edit the e-consent Framework fields to the new v2 variables. In the Optional fields, you can enter the type (i.e. Adult, Assent, Parental Permission Form). Add form display logic for your consent instruments. In this example, if v1 is being used up to 12/10/2022, I will update the logic for both instruments to follow that. Finally, inactivate the old version(s) of the consent survey by turning the status to “Survey Offline” in the survey settings. |
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