During clinical trials, sponsors and CROs provide research sites with Informed Consent Form (ICF) templates, which can be modified by each site and used to consent new participants on the trial. You can create, edit, and save eConsent forms in your Clinical Operations Vault.
In Clinical Operations Vaults with Veeva Site Connect enabled, you can exchange eConsent forms with study sites on SiteVault. Study sites can then use the templates to create blank ICF documents and distribute the approved eConsent forms to study participants. Study participants sign these forms in MyVeeva for Patients.
Creating eConsent Forms
To create an eConsent form, an Admin must first configure the Veeva eConsent field to appear on the relevant document types. When this configuration is complete, users can upload a file, set the configured document type, and set the Veeva eConsent field to Yes.
When you import a document into Vault to create an eConsent form, the file format is maintained for the life of the eConsent form. A PDF eConsent form maintains its PDF format in any later versions, and a DOCX eConsent form maintains its DOCX format in any later versions.
Creating a Word-Based eConsent Form
If you want to collaborate in Microsoft Word while authoring a form, you may upload a DOCX file to Vault. If you create a Word-based eConsent form, you can edit the form in the Veeva eConsent editor to format items such as signature blocks, question blocks, images, and videos.
Creating a New eConsent Form from Microsoft Word (DOCX)
To create a new eConsent form based on a Microsoft Word document:
- Ensure that your DOCX file is formatted correctly based on the Import Guidelines in Using the Veeva eConsent Editor.
- Upload your DOCX file to Vault.
- Select the desired Informed Consent Form Document Type for the file type.
- Enter the ICF’s language, the name of the study, and any other necessary details in the General fields.
- To the right of the Veeva eConsent field, select Yes. Note that an Admin must configure this field to appear on relevant document types.
- Click Save.
- Confirm that the upload was successful in the preview pane.
- From the Actions menu, select Edit eConsent.
- Review the ICF in the Veeva eConsent editor and confirm that the document imported correctly.
- Use the eConsent editor to create and edit the ICF’s sections, content blocks, question blocks, and signature blocks. For more information, see Using the Veeva eConsent Editor.
- When you finish editing the ICF in the eConsent editor, select Check In.
If you’re creating an eConsent form from a Microsoft Word document, you must use the Veeva eConsent editor to add and manage eConsent-specific features like signature blocks, images, and videos. You must also use the eConsent editor to check in the version of the document that you intend to approve for use to Vault. If you import a Microsoft Word document and approve it without reviewing it, editing it, and checking it in to Vault from the eConsent editor, errors occur.
Copying an Existing eConsent Form
To create a new eConsent form by copying an existing study’s form:
- Find the document you wish to copy.
- Click Make a Copy from the Actions menu.
- Ensure that the Copy Content checkbox is selected. Optionally, you can also select the Copy Fields checkbox, but you may need to update the fields to apply to the new blank ICF.
- Click Continue.
- Update and enter any other information as needed.
- Click Save.
Creating a New Draft of an eConsent Form
To update (create a new draft of) an eConsent form:
- Find the document that you want to update.
- Click Create Draft from the Actions menu.
- Ensure that the Copying from current version option is selected.
- Click Create.
You can check out eConsent forms and edit them in the Veeva eConsent editor.
Only one user can check out and edit an eConsent form at a time. If another user has the document checked out, you will see a lock icon in the document’s header area and you will not be able to check out the form to edit.
To check out and edit an eConsent form:
- From the document’s Actions menu, select the option to edit the eConsent form. This checks out the document and opens the Veeva eConsent editor in a new browser tab.
- Make the necessary edits to the form in the Veeva eConsent editor.
- Optional: Click Save to Vault to save a new document version to your Vault without ending your editing session.
- When you finish editing the eConsent form, click Check In to save a new minor version to your Vault, end your editing session, and unlock the document so that other users in your Vault can edit it.
- In the dialog, add any relevant Version Comments and click Check In. When the check in is complete, you are redirected back to your Vault where you will see the updated eConsent form in your Library.
Vault adds a Veeva eForm rendition to the document the first time you save your edits in the Veeva eConsent editor by clicking Save to Vault or Check In.
Canceling Your Checkout
You can cancel your checkout by selecting the option to cancel your checkout from the document’s Actions menu and confirming the cancelation in the dialog. Vault does not save any of the changes you made in the Veeva eConsent editor since you last saved your changes by clicking Save to Vault.
This action is only available to the user that has the document checked out.
Undoing Another User’s Checkout
You can undo another user’s checkout by selecting Undo Checkout from the document’s Actions menu and confirming the action in the dialog. The user that had the document checked out will receive a message that you have undone their checkout. Vault does not save any changes any user made in the Veeva eConsent editor since they last saved their changes by clicking Save to Vault.
This action is only available to users with Document: Cancel Checkout permission and the Edit Document role-based permission for the document.
Previewing eConsent Forms
To preview an eConsent form, select the option to preview from the document’s Actions menu. This action is only available after a user has saved their edits in the Veeva eConsent editor by clicking Save to Vault or Check In.
Sending Documents to Sites
To send eConsent forms via Clinical Network, select Send Document to Sites from the document’s Actions menu. This action is only available when configured by an Admin and under the following conditions:
- The Veeva eConsent field is set to Yes
- The Connected Study Type field contains eConsent
In Vaults with Site Connect enabled, you can exchange eConsent forms with research sites on SiteVault. Sites can edit ICF templates in their SiteVault and distribute approved ICFs to participants. Study participants sign these forms in MyVeeva for Patients. See Sending Documents & Document Requests for details about how to send documents to SiteVault via Veeva Site Connect.
Defining Response Data Labels on Connected eConsent Forms
When study participants sign eConsent forms, their submitted question and signature data is saved in your Clinical Operations Vault. You can define and label the question and signature data from signed eConsent forms when you author an ICF in the Veeva eConsent editor. Use the Question Name, Answer Name, and Signature Name fields on Question and Signature blocks to apply custom labels to response data.
Receiving Participant Response Data from Connected eConsent Forms
When participants submit connected eConsent forms to their sites, the participant response data is automatically recorded in your Clinical Operations Vault. Vault applies the labels you assigned to the form’s Question and Signature blocks in the eConsent editor to the appropriate response records and adds them to the Form Response object.
Receiving Site-Level Changes to Participant Records
When sites change a participant’s Study Participant ID in the participant’s record in SiteVault, the change is automatically applied to the participant’s response records in your Clinical Operations Vault. This means that when site staff change participants’ Study Participant IDs after screening or other study milestones, the participants are linked to all their eConsent form response data at all times.
|Document Role: Edit Document||Ability to edit eConsent forms, allowing you to check the document out to edit in the Veeva eConsent editor when the document is in specific lifecycle states.|
|Document: Cancel Checkout||Ability to cancel checkout on documents that another user has checked out via the Undo Checkout action. Note that you must also have the Edit Document role-based permission on the document to perform this action. Document Owners can always cancel checkout if they have the Edit Document role-based permission.|
|All Documents: All Document Actions||Ability to cancel checkout on documents that another user has checked out via the Undo Checkout action. Note that you must also have the Edit Document role-based permission on the document to perform this action. Document Owners can always cancel checkout if they have the Edit Document role-based permission.|