...
| Excerpt | ||
|---|---|---|
| ||
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
...
| Excerpt | ||
|---|---|---|
| ||
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. 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. 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. |
Go to Next Page, or return to Table of Contents.