Create REDCap e-Consent Survey

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:

   

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

   

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. 

      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:

         

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:

   

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

   

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:

   

   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.

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.

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

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:

Copying and Pasting Lists

Format of bulleted and numbered lists is not maintained when copying and pasting from the .rtf form into REDCap field editors.

One method to overcome this is to remove the bullets from the .rtf document before copying and pasting. To do this, highlight the list → Click the List and Tab Left icons on the Word menu:

Copy the list without the bullets

Paste into the REDCap field editor, highlight the text, and select the bullet icon from the menu:

The list will look like this (bold was removed from text as well):

Yes-No Response Fields

Yes-No response fields will look slightly different in the REDCap e-Consent survey than on the .rtf document. The design was altered in REDCap as a quality assurance step. On the .rtf document, the fields appear like this:

Using this same format in REDCap could lead to entering initials in the wrong field or both fields. In REDCap, there will first be a Yes-No question followed by initials fields which are hidden by branching logic:

All participant response fields need to have the @READONLY-FORM action tag:

Participant Signature Field - Voluntary Consent

A Statement by person agreeing to be in this study: field should precede the participant signature field, followed by Participant Full Name and Date of Consent fields:

The signature and name fields have the @READONLY-FORM action tag. The date field has the @NOW and @READONLY action tags. This is to ensure the date the participant signed is entered to the date field.

Study Team Signature Field - Attestation

A descriptive field with a message BEFORE STUDY TEAM MEMBER SIGNS should precede the Statement of Person Who Obtained Consent, Signature of Person who Obtained Consent, Name of Person who Obtained Consent and Date and Time fields, and end with a message stating Select Save & Exit Form after completing attestation:

All of these fields should have the @HIDDEN-SURVEY action tag. The BEFORE STUDY TEAM MEMBER SIGNS and Select Save & Exit Form after completing attestation should also have the @HIDDEN-PDF action tag:

Tables

Tables can easily be created using the Rich Text Editor Table tool:

Figures

Figures can be 1) pasted directly into the field label or 2) uploaded to a descriptive text field and displayed inline

1. Note the field label box has been expanded by clicking the full screen button to show the pasted image:

   

2. Uploading a file and choosing Inline image/PDF

   

3. Both of these options will display: