Human Subjects ResearchResearch Data

Part 11 Compliance – Electronic Records & Signatures

Part 11 of the Code of Federal Regulations (CFR) contains the Food & Drug Administration’s (FDA) rules and regulations pertaining to electronic records and electronic signatures. 21 CFR Part 11 defines the criteria for which systems and processes are trustworthy, secure, and reliable for electronic records and signatures. Below you will find WashU resources on how to comply with CFR Part 11.

WashU Compliance Statements & Guidelines


Webinars for DocuSign

  • DocuSign in WashU Research (February 23, 2022)
    This webinar discusses typical participant use cases for DocuSign Standard and DocuSign Part 11 in WashU research. It also introduces you to the requirements for using DocuSign Standard and/or DocuSign Part 11 in research at WashU.
  • Which forms should I use in DocuSign Part 11 v. DocuSign Standard? (August 11, 2022)
    This webinar provides background information on using DocuSign in WashU research, which forms are needed in Part 11 vs. Standard, and templates.

Resources for DocuSign


Webinars for Box

  • Using Box in Part 11 Regulated Research (October 2022)
    This webinar discusses the using Box in Part 11 regulated research by orienting the audience to the Box SOP and training, and discusses creating a checklists to confirm best practices are in place for the use of Box.



mHealth Research Core (mHRC) Online Navigation Tools

  • REDCap eConsent
    This page provides an overview of when and how to use REDCap for electronic informed consent, and the steps on how to create an eIC in REDCap.
  • WashU Resources
    Here you will find information on funding opportunities, JROC’s legal review processes, WashU regulations and offices for human studies, and data storage and processing resources.
  • Telehealth + Virtual Research Sessions
    mHRC can help in determining how best to operate as a fully remote clinical research study.
  • mHealth Technology in FDA Regulated Trials
    A navigation tool the mHRC put together to help you balance regulatory considerations while moving your Part 11 regulated research project forward.
  • Technology Partnerships
    A helpful resource to help you navigate your partnership with a 3rd party technology vendor.
  • Coming Soon
    • DocuSign eConsent
    • Digital Tools for Recruitment

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