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Operational aspects of informed consent can be captured in REDCap to meet part 11 compliance. For more information, see U of U policies or the FDA website.
Version Control
When informed consent documents are updated, it is important to track new versions. 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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