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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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File Repository

To view PDFs of locked records, signed e-consent surveys, and other uploaded files, navigate to the "File Repository" under Applications in the left navigation bar. 

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To view signed e-Consent PDFs, navigate to the “PDF Survey Archive” folder.

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You will see a list of signed e-consent surveys.

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Version Control

When informed consent documents are

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updated, it is important to track new versions. To update consent documents in a project, use 1 of 2 options:

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title1. Use branching logic within the instrument

If using .png images of the consent document, add descriptive text field(s) with new version pages with variable names appended with _v2. Apply branching logic to show field depending on conditions.

If using inline descriptive text with the consent document information, simply copy the field, append _v2 to the new field, make edits where necessary, and apply branching logic to show field versions depending on conditions as shown above.

In the survey settings, make sure to edit the e-Consent version field to the new version number. In the Optional fields, you can enter the type (i.e. Adult, Assent, Parental Permission Form). Make sure to save your changes.

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title 2. Create new instrument

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). Make sure to save your changes.

Make sure to inactivate old Automated Survey Invitations (ASIs), modify Alerts, or modify the Survey Queue depending on your distribution method.

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It may be beneficial to add form display logic for your new 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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