Adobe Sign Part 11 Validation Complete — Ready for Electronic Signature use in the School of Medicine
Documentation is critical to the good conduct of clinical research. The need to move from a paper-based infrastructure to digital systems has never been more important than during the COVID-19 pandemic.
A major challenge in creating digital systems is ensuring they are secure for their intended research purposes. This month, the Office of the Senior Associate Dean for Research in the School of Medicine is pleased to launch Adobe Sign, which has been fully validated for compliance with 21 CFR 11 (“part 11”) and is ready to use for electronic signatures in research.
The hardest part [of managing compliance] especially during COVID, was get timely PI signatures on urgent documents. Being able to use Adobe Sign has dramatically increased our efficiency. Another bonus of being able to utilize Adobe Sign for PHI is being able to minimize paper documents.” — Alison Holzer-Speed, Director, Stem Cell and Gene Therapy Clinical Trials Office. “We appreciate the hard work of the team that put this together.
Stanford has a long history of systems, such as eProtocol, OnCore, and REDCap, which can securely manage research data and protected health information (PHI). Now, Adobe Sign is not only secure for PHI, but also validated by a team from the Research Office, The Stanford Center for Clinical Research (SCCR), and Technology and Digital Solutions (TDS), to be fully compliant with part 11 – enabling researchers to use it for e-signatures on all research documents required for FDA-regulated research.
When Should You Use Adobe Sign?
With this new option for study teams, navigating when and how to use Adobe Sign may be an obstacle. The matrix below provides some guidance. Standard Operating Procedures (SOP) and Work Instructions are available to help get you started. The Research Office website will be the best place to find more information and Frequently Asked Questions as they become available.
|Documents requiring e-signature
|FDA-regulated research documents with PHI
|FDA-regulated research documents without PHI
|Documents for non-FDA regulated research with PHI
|Documents for non-FDA regulated research without PHI
For questions about obtaining a PHI-configured local group established in Adobe Sign, submit a Help Ticket.
For additional information, contact firstname.lastname@example.org. You can also join the Adobe Sign Community of Practice via the Slack channel “#adobesign_part11.”
The Adobe Sign Validation Committee was led by Jennifer Brown, Assistant Dean, Compliance, Regulatory and Quality, and Todd Ferris, Chief Technology Officer, Research Informatics (sponsors of the initiative), and consisted of Maya Berdichesky from SCCR and Spectrum, Bhanu Sharma from SCCR, and Anthea Buchin, Megan Saeedi, and Jane Beggs from the Office of Clinical Research Quality (CRQ). Advisors included Brian Gin and Manjit Gil from University Privacy Office, Leo Volkov and Sunny Sopapunta, University Information Security, Lisa Denney and Maria Aldeguer at the IRB.
Special thanks to the individuals who participated in the performance qualification portion of the validation: Abhay Raj Singh (Sean N. Parker Center for Allergy and Asthma Research); Amishi Jobanputra (Orthopaedic Surgery); Mary Maldonado (CRQ); Scott Patton (CRQ); and Mitra Kashanian (Neurology).
Funding for this initiative was provided in part by the Stanford CTSA Award Number UL1TR003142 from the National Center for Advancing Translational Science (NCATS), a component of the National Institutes of Health.