# Add Consent Form to Study

Source: https://sites.veevavault.help/gr/sitevault/econsent/create-template/

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](/gr/sitevault/econsent/builder-import/) 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](/gr/sitevault/econsent/builder-import/#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](/gr/sitevault/getting-started/languages/) 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](/gr/sitevault/econsent/edit-pdf/).
- **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](/gr/sitevault/econsent/edit/).

## Step Three: Approve an eConsent for Use

See [Approve an eConsent Form for Use](/gr/sitevault/econsent/approve/).