Clinical studies are required to have participants review and sign consent forms to participate. You might even sign different versions of the forms over time. For many studies, these forms are signed on paper. MyVeeva for Patients allows you to review, complete, and download consent forms online.
For some studies, you might review the form with the site coordinator in person, on the phone, or online. No matter how you communicate with the site, you can contact them if you have questions about the study before you sign or decline a form, and you can also download the form if you want to share it with your family or care team offline.
And if you’re a witness, translator, guardian, representative, or proxy, you can also use MyVeeva for Patients to sign consent forms.
Tip If you’re a registered user, make sure you have your mobile phone nearby if you’re not already using it. You may need it to verify your identity. If the study team didn’t enter contact information for you and you’re not registering an account, you’ll complete your forms in person and won’t need to verify your identity with your mobile phone.
Reviewing Consent Forms
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- Select View Consent Form in the invitation email, scan the QR code shown to you by the site coordinator, or select the Tasks page in the sidebar. If you use MyVeeva for Patients in more than one role, you may need to select the Account icon (
) in the upper-right corner and select your role after you log in.
- Select one of the consent forms on the Tasks page.
- Scroll through the form and review it. As you view its sections, your progress is displayed on the table of contents. The table of contents is displayed to the right of the form on larger screens and in the hamburger menu on smaller screens. A checkmark on the table of contents means you’ve viewed that section or answered its required question.
- If you’re done reading a section and the form includes more than one, select Next Section at the bottom of the page. You can also select a section on the table of contents to skip to it, but you’ll need to view all sections before you can sign.
Tip You can zoom in using your browser if you’re having difficulty reading the form, and you can use your mobile device to zoom in on images and pan around them.
- Select View Consent Form in the invitation email, scan the QR code shown to you by the site coordinator, or select the Tasks page in the sidebar. If you use MyVeeva for Patients in more than one role, you may need to select the Account icon (
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Document table of contents in the Android app Document table of contents in the iOS app - Select the Tasks icon (
) . If you use MyVeeva for Patients in more than one role, you may need to select the Account icon (
) in the upper-right corner and select your role after you log in.
- Select one of the consent forms on the Tasks page.
- To review the form, you can scroll through the document or select Table of Contents to navigate to a section. As you view the sections, your progress is displayed in the Table of Contents tab. A checkmark means you’ve viewed that section or answered its required question.
- Select the Tasks icon (
Answering Questions on Consent Forms
If you’re the main reviewer on the form, you have to answer any required questions to mark their sections complete and sign the form. If a question is optional, you can either answer it or submit the form without an answer.
If multiple people review a form (for example, if a proxy is signing for a participant as well as a witness), only the main reviewer answers the questions. The other reviewers see their answers when reviewing the form. If two guardians are signing, only the first to review answers the questions.
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Answering a question on a consent form in the Android app Answering a question on a consent form in the iOS app
- One Answer: For questions with only one answer, select the checkbox next to the answer if it applies to you. Questions with only one answer are always optional.
- More Than One Answer: For questions with more than one answer, select the option for your answer. Questions with more than one answer can be optional or required. We display required questions with a red bar next to them.
Signing and Submitting Consent Forms
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- Go to the document’s signature section. The section is indicated by an orange box that points to it on the table of contents and the page. You might need to complete the following steps:
- If you haven’t viewed all of the form or answered all of its required questions, select View Uncompleted Section in the signature block. Complete that section and any others that don’t have a green checkmark on the table of contents.
- If the form requires an unlock code, select the signature block and enter the code when the study team gives it to you. Some studies use unlock codes to make sure you have a chance to ask questions before you sign.
- Apply your signature by completing one of the steps below. For some studies, you may be required to draw your signature. For others, you can choose how you want to sign by selecting the Draw Your Signature Instead or Tap to Sign Instead links.
- Click or Tap to Sign: Select the signature block for your role. We’ll automatically fill in your printed name and the date when you submit the form, so you only need to click or tap to sign.
- Draw Your Signature: Draw your signature in the signature box. If you want to redraw your signature, select the Clear Signature link.
- Select Submit at the top of the page to send the form to the study team. If you clicked or tapped to sign, you’ll need to enter the six-digit code we send you in a text message. If you don’t receive it, select Send Another Code to get another text message or Get a Voice Call to get a phone call.
When a study team member signs the form, we’ll update the .PDF file in MyVeeva for Patients to include their electronic signature at the end.
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Submitting a consent form in the Android app Submitting a consent form in the iOS app - Go to the document’s signature section. The section is indicated by an orange box that points to it on the table of contents. You might need to complete the following steps:
- If you haven’t viewed all of the form or answered all of its required questions, select Table of Contents and view or complete any sections without a green checkmark.
- If the form requires an unlock code, select the signature block and enter the code when the study team gives it to you. Some studies use unlock codes to make sure you have a chance to ask questions before you sign.
- Apply your signature by completing one of the steps below. For some studies, you may be required to draw your signature. For others, you can choose between tapping to sign or drawing your signature.
- Tap to Sign: Select the signature block for your role. We’ll automatically fill in your printed name and the date when you submit the form, so you only need to tap to sign.
- Draw Your Signature: Select Or You Can Draw Your Own Signature below the signature block then draw your signature and select Apply. If you want to redraw your signature, select Clear.
- Select Submit Signed Document to send the form to the study team. If you clicked or tapped to sign, you’ll need to enter the six-digit code we send you in a text message. If you don’t receive it, select Send Code to get another text message or Get a Call to get a phone call.
When a study team member signs the form, we’ll update the .PDF file in MyVeeva for Patients to include their electronic signature at the end.
Declining Consent Forms
When you decline a form, it means you don’t consent to what’s on it. This might mean that you or the participant can’t take part in the study, so please talk with your site coordinator if you’re unsure.
If multiple people are reviewing the form and one of them declines it, the form is declined for everyone but is still on the Documents page if they want to read it. If someone declines when they don’t mean to or changes their mind, contact the study site and ask them to resend the form.
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- In the banner at the top of the form, select I don’t want to sign this document.
- Select Decline.
Note You can't select the link to decline if you've applied your signature but haven't submitted the form yet. To view the link again, select the X in the signature field to clear it.
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Declining a consent form in the Android app Declining a consent form in the iOS app - Select the ellipsis (...) at the top of the consent form.
- Select Decline to Sign.
- Select Decline.
Note Decline to Sign is not displayed if you've applied your signature but haven't submitted the form yet. To view the button again, select the X in the signature block to clear it.
Downloading Consent Forms
- Select the Download PDF button (
) at the top of consent form. You can also download the form later on the Documents page.
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- Select the consent form that you want to download.
- Select the ellipsis (...) at the top of the consent form.
- Select Save as PDF.
- Select Save to Files.
- Select a location to save the .PDF file to.
- Select Save.
Withdrawing From a Study
To withdraw from a study or withdraw a participant, call or email the study site.