Question: What instance of DocuSign should I request access to?

Answer: When deciding which instance of DocuSign to use, start by considering whether it needs to be 21 CFR Part 11 compliant. The SMPH Clinical Research instance is compliant for use with FDA regulated clinical trials, and sending envelopes incurs a flat fee per envelope sent. The UW Madison instance, used by most members of the university, is NOT 21 CFR Part 11 compliant and sending envelopes does not incur a fee. Lastly, the Carbone Cancer Center instance is no longer in use. If you previously used this instance, request access to the SMPH Clinical Research instance at this time.

Question: How do I login using Single Sign-On (SSO)?

Answer: 

1. Enter your UW email address and select Next

 2. Select 'Use Company Login'

You will be redirected to UW NetID Login page, if not done already

Question: How do I know what instance I am signed in to?

Answer: Select your profile picture on the top right of the home page and observe the drop down window:

Question: How do I change my instance?

Answer:

1. Select your profile picture on the top right of the home page.

2. Select 'Switch Account'

3. Select the desired instance:

Note: If you do not see the 'Switch Account' option, you only have access to a single instance of DocuSign and will need to request access to other instances.

Question: Do the signatures in the SMPH Clinical Research (i.e., 21 CFR Part 11 compliant) instance and the UW Madison instance look the same?

Answer: No, the signatures do not look the same. As shown below, signatures using the SMPH Clinical Research instance include the signer name (printed), signing reason, and signing date/time. These fields are not included in signatures using the UW Madison instance.

Question: How do I send an envelope?

Answer: Refer to this video by DocuSign: Send a CFR Part 11 Envelope with DocuSign (Video)

Question: How do I sign documents in an envelope?

Answer: Refer to this video by DocuSign: Sign a CFR Part 11 Envelope with DocuSign (Video)

Question: What if I have additional questions about using DocuSign?

Answer:

1. Refer to this guide by DocuSign: eSignature Basics for Senders
2. For template related questions, refer to these guides and videos by DocuSign: Template Creation and Use with DocuSign
3. If your question was not answered by referencing the resources above, submit a ticket to the Clinical Trial Application Support Help Desk

Question: What is DocuSign used for?

Answer: DocuSign can be used for obtaining signatures on documents that do not get filed in Florence (e.g., PI research procedures memo) or for those requiring a signature from someone outside the UW (e.g., potential participant signing consent).

Question: How can I tell whether my study uses DocuSign for consent (UW Carbone Cancer Center only)?

Answer: Check the Annotations tab in OnCore. The pathway is OnCore > PC Console > (enter UW study number) > Annotations tab > DocuSign section.

Question: Can I store documents in DocuSign?

Answer: DocusSign should not be treated as a document storage system. Study teams are expected to download completed documents and move them to where they store their other study and/or regulatory documentation.

When doing so, study teams should also create and store a copy of the certificate that verifies the authenticity of electronic signatures outside of DocuSign with other regulatory and/or study documentation prior to deletion from DocuSign.

Question: How do I obtain a signing certificate for e-signatures on my documents?

Answer: 

1. Wait for the envelope to receive all requested signatures
2. When the 'Completed' email is sent to you, select the 'View Completed Document' link from the email
3. Login to DocuSign
4. At the top of the page for your envelope, select 'Download'
5. From here you can select 'Combined PDF' or 'Separate PDFs'
   1. Combined PDF: This option appends the certificate to the documents in the envelope
   2. Separate PDFs: This option separates the certificate from the documents, providing it as a separate PDF
6. Note: You may also access the file while logged in to your DocuSign account by doing the following:
   1. From the DocuSign home page, select the 'Completed' tile
   2. Navigate to the desired envelope and select 'Download' on the right side
   3. Deselect everything except 'Certificate of Completion' and select 'Download' to obtain a copy of the certificate