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DocuSign eSignature

What is DocuSign?

  • DocuSign is a cloud-based software program that makes it easy to collect electronic signatures.
  • Using an electronic envelope, senders can upload documents, add signature, and date fields, and send the envelope via email to a recipient or set of recipients.
  • Using DocuSign streamlines the process of obtaining signatures on documents, such as protocol signature pages, grant administration documents, informed (electronic) consents, FDA forms, and more.

Requesting Access to DocuSign

  • DocuSign accounts must only be set up for those who will create and send documents (i.e. Senders).
    • To obtain a sender's account, please submit a request to the designated DocuSign administrator within your department/office.
  • If only signing documents, you can sign the document using your HS account.
  • If you need assistance, please submit a support ticket at IT Service Portal

How do I Login to DocuSign? (Two Options)

  • Option 1: You can click on the following "DocuSign" icon. Enter your HS username and password (username@hs.uci.edu)
  • DOCU Sign Login
    UCIHS Docusign Login

  • Option 2: Visit www.docusign.com and click "Log In" at the top right. Enter your @hs.uci.edu email address. Then, enter your HS username and password, and then multifactor authenticate (if prompted).

What is an electronic signature?

The US Federal ESIGN Act defines an "electronic signature" as an electronic sound, symbol, or process, attached to or logically associated with a contract or other record and executed or adopted by a person with the intent to sign the record. Electronic signatures have been used for electronically signing offer letters, sales contracts, permission slips, rental/lease agreements, liability waivers, financial documents, etc. They are legally enforceable in most business and personal transactions in almost every country in the world. Learn more in our eSignature Legality Guide.

Is DocuSign 21 CFR Part 11 Compliant?

There are two instances of DocuSign available:

  • UCIH Standard (DocuSign Standard)
    • For use with Non-Regulated Use Cases
    • Not 21 CFR Part 11 compliant
  • UCIH Part 11 (DocuSign Part 11)
    • For use with Regulated Use Cases Governed by FDA 21 CFR Part 11
    • Instance has been validated as 21 CFR Part 11 compliant
    • Statement on University of California, Irvine Health Compliance with 21 CFR Part 11 may be obtained from your office administration.

*Due to the limited number of Part 11 DocuSign envelopes available to UC Irvine Health, users should be strategic when sending documents for DocuSign Part 11 electronic signature (UCIH Part 11) - include multiple documents to be signed in one envelope.

Should I Collect Signatures via DocuSign Standard or DocuSign Part 11?

Usage Examples

DocuSign Standard
Non-Regulated Studies and Documents

DocuSign Part 11
FDA-Regulated Studies and Documents
(only a sub-set of FDA-regulated documents will be included)

All research-related documents for Non-FDA- Regulated Studies

Legal, financial, and other documents that are not submitted to the FDA/not a part of FDA-regulated studies, including

  • 700U
  • Delegation of Authority Log
  • Protocol Training
  • Protocol Signature Page and/or Investigator's Brochure Acknowledgement of Receipt
  • Source Document and/or Electronic Medical Record Questionnaires
  • Personal data agreements for study team

MUST be used to collect signatures on documents required to be submitted to FDA and/or involved in FDA-Regulated studies

  • Forms 1572, 1571, 3926
  • Financial Disclosure Form
  • Informed Consent Form
  • Patient Source Document Logs (Event Log, Adverse Event Log, Medical History Log, Tumor Log, Concomitant Medication Log)
  • Corrective and Preventive Action (CAPA) Plan

How do I Determine which DocuSign instance (UCIH Standard vs UCIH Part 11) I am logged into?

  • Your current DocuSign instance will display on the DocuSign homepage when you are signed in.
    DOCU Sign Login
  • Users can also click their user icon on the upper right to determine which instance they are logged into. If you have access to both types of accounts, click on "Switch Account" to go back and forth between UCIH Standard and UCIH Part 11.
    Part 11 Module Enabled

Can DocuSign be Used to Sign Documents that include PHI?

Yes. DocuSign is HIPAA compliant. Both DocuSign Standard and the Part 11 module may be used to collect signatures on documents containing PHI.

What DocuSign terms should I be familiar with?

Document: The file or files (word, Excel, PDF, JPG, etc.) uploaded into DocuSign for signature. Documents are packaged into an envelope and sent for signature.

Envelope: The electronic container holding the document(s), recipient information, and tracking information.

Sender: Someone who initiates and sends a document for signature. A sender must be associated with a subscription account and have sender permissions to send a document.

Signer: Someone who signs a document. A signer does not need to be associated with an account to sign a document.

Signing Group: A predefined group of recipients where anyone in that group can open an envelope.

Permission Sets: A group of options that determine what a user can and cannot do in DocuSign.

Learn more about DocuSign eSignature:

DocuSign offers a variety of informational and educational resources. Visit DocuSign Basics for a general understanding of how to use DocuSign, visit DocuSign Higher Ed Forum to read or ask questions for a community of higher education users, visit the DocuSign Knowledge Market for white papers, best practices, and adoption tools, visit the DocuSign Support for how-to guides, and visit DocuSign University (login required) to check out free and fee-based training.

DocuSign videos: