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Create REDCap e-Consent Survey

Create REDCap e-Consent Survey

Purpose: Guide to recreating Informed Consent Form as the Informed Consent Form V1.00 App mmddyyy instrument in the template so it can be used as the e-Consent Survey. All text and formatting from the ICF must be copy and pasted into the e-Consent instrument before it will be approved by the IRB. Uploading a file of the ICF and displaying it inline is not acceptable. It is recommended that you:

  1. Submit at least 1 draft of Informed Consent Form and receive feedback from IRB prior to creating this survey.

  2. Save the final version of your ICF document that you upload to myIRB prior to approval in order to copy and paste from that file.

If you do not have experience building REDCap instruments, please watch the Creating Forms and Surveys webinar.

Webinar Recording with Step-by-Step demonstrations

https://youtu.be/SCYAaMa22u0

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Description of e-Consent Survey Template

The e-Consent Survey template has several example fields available by default. Many of the fields contain red, italicized text. which provide additional guidance to format the fields. The red, italicized text should be deleted prior to sending to the IRB for review. There are different field types to contain different information from the ICF. Descriptive text fields are used when only text is needed, and no data will be collected, for example, the [irb_stamp], [study_purpose], and [vol_consent_agreement].

 

Modifying and Formatting the Example Fields

The easiest way to format the fields exactly the same as the ICF is to use the Rich Text Editor on the Field Editor. To access this:

  1. Online Designer → Informed Consent Form V1.00 App mmddyyyy → Click the Edit Field icon on any field to enable the Rich Text Editor:

    image-20250124-150712.png

     

  2. If you choose to use an example field that has a screenshot embedded, you can remove the file from the field:

    image-20250124-171501.png

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Consent PDF Field

  1. [consent_pdf] is optional. The purpose, if the field is used, is to allow participants to view the Informed Consent Form (ICF) in original format before moving on to the e-Consent survey.

    1. You can delete it if this is not necessary for your participants. 

    2. If you choose to use it, follow the steps to set up

      1. Upload PDF copy of ICF

      2. Choose Link or Inline image/PDF. 

        1. Link allows download of PDF

        2. Inline image/PDF allows preview of PDF in web browser in addition to download.

      3. image-20250118-131401.png

         

      4. @HIDDEN-PDF action tag removes this field from the fully executed consent

      5. If Inline Image/PDF is selected, the field will appear like this:

        image-20250124-154933.png

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IRB Stamp Field

The purpose of this field is to contain exactly what is on the IRB Approval Stamp in the upper right corner of the approved ICF document. Enrolling a participant with incorrect IRB Approval information is considered noncompliance.

  1. Prior to IRB Approval, the stamp on ICF will have placeholder text that look similar to the screenshot below:

    image-20250124-140801.png

  2. The irb_stamp field will have placeholder text as well:

    image-20250124-155119.png

     

  3. After IRB Approval, the placeholders will be filled with an IRB ID, approval date, release date, and, if applicable, an expiration date. The placeholder text will need to updated AFTER the ICF is approved by the IRB:

    image-20250124-155345.png

     

    1. Expiration date may not be included on some approved ICFs

       

  4. Please ensure the information you enter following IRB approval matches exactly what is on the IRB Approval Stamp. Enrolling a participant with incorrect IRB Approval information is considered noncompliance.

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Version Field

The first approved e-Consent survey should be listed as Version #: 1.00 with the approval date.  Enter the date after final approval from the IRB.

image-20250124-160005.png

This field was added primarily for Sponsor Initiated Studies. If your study is not sponsor initiated, you can use the @HIDDEN-SURVEY action tag to hide this field from participants

image-20250124-160227.png

image-20250124-160159.png

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Formatting Paragraphs and Lists

Paragraphs, bulleted lists, and numbered lists are best inserted into descriptive text fields with the text can be split into different fields as best makes sense for your ICF. For longer ICFs, you may choose to separate the survey into multiple pages and group the text based on what will be on each survey page. In the screenshot below, the irb_stamp, consent_version_info, consent_project_info, study_purpose, and study_happen sections are grouped between two section header fields:

 

image-20250124-163816.png

 

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