Using SiteVault and the eConsent tools, you can upload an existing form or create a new form and edit it to meet the needs of the study. eConsent forms can be PDF or DOCX (Word) file types. When working with PDF-based consent forms, users can overlay question and signature elements directly onto pre-approved PDF consent files, enabling the use of unmodified IRB-approved ICFs.

eConsent Editor and Builder Tools

PDF-Based eConsent Editor Recommended
Site users can overlay question and signature elements directly onto PDF consent forms. Uploading IRB-approved PDF consent forms avoids additional IRB reviews after digitizing. If the document provided to you is a Word document, use Save As to save as a PDF to use the PDF-based eConsent Editor.

Custom eConsent Builder (DOCX / Microsoft Word™)
You can create an eConsent form by importing content from a Word-based document and finish editing in the Custom eConsent Builder. You will use the Builder to add digital-specific items such as signature blocks, question blocks, images, and videos. You can also import content using an eConsent Share Code or upload a SiteVault eForm (JSON). For more importing information, see Import Consent Forms in the Custom eConsent Builder for more information.

Please note that using the Builder to edit an IRB-approved document may require an additional review. To instead use the PDF-based eConsent Editor to overlay consent elements on your IRB-approved consent form, use Save As to save your Word document as a PDF.

Step One: Select or Upload the New Form

Upload an existing form or create a new one and edit it to meet the study’s needs. SiteVault imports the content from your form but requires manual adjustments to capture signatures and responses.

1. Navigate to Studies.
2. Select a study.
3. Select Consent Forms.
4. Select + Add eConsent.
5. Select the eConsent Type. This selection determines the options available in the next step.
   • Select from:
     • Simple PDF-based eConsent (overlay signature and question elements onto PDF)
       • If the document provided to you is a Word document, use Save As to save as a PDF and use Simple PDF-based eConsent.
     • Custom eConsent Builder (build form structure into a Word document)
6. Select Next.
7. Select from the following options:
   • Browse ICFs: Select a consent form already present in your SiteVault.
   • Upload a New Document: Upload a new document saved locally on your computer.
     • If upload is a Word document (DOCX), first review Word Document Formatting Requirements.
     • Complete fields using the guidance below.
       • Document Date: If the default date (today) is not appropriate, select the appropriate date. If applicable, consider the IRB approval date.
       • Language: Select the appropriate Document Language if different than the default language.
       • Description: Include details specific to this document.
8. Select Launch Editor.

Step Two: Edit Form Sections, Headers, and Questions

• Simple PDF-based eConsent
  To overlay signature and question elements onto a PDF eConsent form, see Edit a PDF eConsent Form.
• Custom eConsent Builder
  To edit, build the structure, and add components into a Word (DOCX) eConsent form for approval, see Edit a DOCX eConsent Form.

Step Three: Approve an eConsent for Use

See Approve an eConsent Form for Use.