Stanford Adobe Sign

Adobe Sign is the School of Medicine’s recommended tool for obtaining electronic signatures on research records for clinical studies. When used according to the approved procedures, this cloud-based solution is both 21 CFR Part 11 compliant and safe for Protected Health Information (PHI).

With Adobe Sign, your study team can now manage e-signatures and documents in a digital environment.

• Part 11 compliant — Adobe Sign is validated to be compliant with 21 CFR Part 11 when using the approved procedures, enabling researchers to use it for e-signatures on all research records required for FDA-regulated research.

• Secure — Adobe Sign, when configured to manage PHI, utilizes passwords to protect records and authenticate users.

• Efficient and flexible consent process — Adobe Sign lets you obtain e-signatures for informed consent and other research records from participants and research team members anywhere on any computing device or mobile device.

Some approved uses include, but are not limited to:

• Informed consent process documents

• Serious adverse event forms and reports

• Delegation of authority logs, training records, notes-to-file

• A Stanford Adobe Sign local group account configured for secure management of PHI
• IRB approval to use Adobe Sign for participant-facing research records, e.g., informed consent or related process.
• Training in the use of and following approved procedures (see “Get Started” below) 
• Up to date HIPAA training
• For additional requirements see section 9 of SOP-086

No individual licenses are required to use Adobe Sign at Stanford, and there is no cost to get access.

No individual licenses are required to use Adobe Sign at Stanford, and there is no cost to get access.

No individual licenses are required to use Adobe Sign at Stanford, and there is no cost to get access.

March 16, 2022

Adobe Sign Part 11 standard operating procedures and work instructions have been updated and approved for use. They include a screenshot and instructions for users to help them verify that they are in a PHI group.

Using Adobe Sign for Research Records that Require Part 11 Compliant Signatures (SOP-086)

Using Adobe Sign to Obtain Part 11 Compliant Signatures During Informed Consent (WI-009)

No individual licenses are required to use Adobe Sign at Stanford, and there is no cost to get access.

To get started with Stanford Adobe Sign:

1.  Complete the following training:

Download and read:

·  SOP-086 Using Adobe Sign for Research Records that Require Part 11 Compliant Signatures

·  WI-009 Using Adobe Sign to Obtain Part 11 Compliant Signatures During Informed Consent

Document that you have read and understood the approved procedures by completing this SOP Training Record. Training is required.

CRQ offers virtual training opportunities via the Clinical Research Operations Program (CROP). 

2.  Determine if your current Stanford Adobe Sign local group account is configured for secure management of PHI, establish or join a local group account. Submit a Help Ticket if you need more information.

3.  Launch Adobe Sign from the University IT website and log in with your SUNet ID via Stanford’s web authentication.

1. SOP-086 Using Adobe Sign for Research Records that Require Part 11 Compliant Signatures
2. WI-009 Using Adobe Sign to Obtain Part 11 Compliant Signatures During Informed Consent
   

For general questions about Stanford Adobe Sign for use in clinical research, please contact the Office of Clinical Research Quality at clinicalresearchquality@stanford.edu.

Submit a Help Ticket if you need technical support.

Join our Slack channel in the School of Medicine workspace. Search for #adobesign_part11 in Slack.

To inquire about using Adobe Sign for NIH Other Support, visit RMG NIH Other support webpage:  

https://med.stanford.edu/rmg/resources/federal-agency-disclosure/nih-other-support.html