Version: 12
Digital Signature Requirements
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Researchers must follow procedures to meet compliance as outlined in the eConsent REDCap Template project template. Fields and forms may be ammended amended based on study requirements. For FDA regulated studies, the e-consent and documentation of informed consent instruments should be used as is.
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Gathering Participant Contact InfoInitial participant contact information should be collected by study personnel and entered into the Participant Contact Info instrument. This instrument will collect the date, participant’s name, email, DOB, and preferred language, consent type, age group, and a field that will trigger the e-Consent form to be sent electronically.   |
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e-Consent InstrumentsElectronic 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. Best practice is to include the version number and IRB approval date in the e-Consent version field.   The consent date field has a minimum and maximum validation set to ‘today’.  Always capture every component that has been approved on your IRB consent within the signature block, whether that be name, dob, signature. This includes specific discrete fields captured in your consent document ie, (genetic result storing, f/u for future studies, etc)  |
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When informed consent documents are updated, it is important to track new versions. To update consent documents in a project, enter DRAFT mode and follow 1 of 2 options: OPTION 1. 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 with the new IRB approval date. In the Optional fields, you can enter the type (i.e. Adult, Assent, Parental Permission Form). Make sure to save your changes.  Submit your changes for review. OPTION 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 and the new version number with the new IRB approval date. 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.   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.  Inactivate the old version of the consent survey by turning the status to “Survey Offline” in the survey settings.  Submit your changes for review. Once the changes have been approved, don’t forget to add user rights to your new instrument(s). For further instructions see the Add, Edit, Remove Users From Your Own Project knowledge article. |
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