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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 based on study requirements. For FDA regulated studies, this template should be used as is.
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Gathering Particpant 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.   The consent date field has a minimum and maximum validation set to ‘today’.  |
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Using e-Consente-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. To send e-Consent through an ASI, the link is sent to the participant using information provided in the Participant Contact Info instrument. Conditional logic and settings should be defined to designate to who and when to send e-Consent.   To open the survey from within the project for a participant, navigate to the Econsent instrument to be used from their record. In the Survey options dropdown, select “Open as a Survey”.  When the participant opens the survey, they will see a form similar to the one shown below.  On the next page, the participant reviews their consent document, and they will check the box certifying their electronic signature.  Assent and Parental Permission SurveysFor participants aged 7 to 17, an assent survey is needed. This requires the same information as the example above - participants name, date of birth, signature, and date of signature.  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.  Additional Electronic ConsentThere are instruments included in the template for situations where legally authorized representative (LAR), witness, and/or interpreter consent documents are needed. File RepositoryTo 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.  To view signed e-Consent PDFs, navigate to the “PDF Survey Archive” folder.  You will see a list of signed e-consent surveys.  |
Version Control
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:
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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). 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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