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
- EPIC Part 11 Compliance Statement
The purpose of this statement is to provide WashU investigators and research staff with guidance for responding to inquiries about WashU’s use of the Epic Electronic Health Record (EHR) system with compliance to CFR Part 11. - HRQA: Electronic Storage of Human Research Study Documents
This page includes best practices and an FAQ on storing human research data at WashU. - Electronic Medical Records Questionnaire
This document serves as a tool to provide guidance and assist in collecting information used when answering sponsors’ questionnaires regarding the use of Epic as our electronic medical record.
DocuSign
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
- WashU DocuSign Standard Operating Procedure
This SOP applies to all active WashU faculty and staff engaged in research activities requiring electronic signatures for regulated study activities under Part 11. - Information Technology: DocuSign
This hub of information provides details from Information Technology on how to access and use DocuSign, along with best practices, resources, and support. - DocuSign Justification for Use Memo
- FAQ Guidance
This is a helpful 2-page document with general guidance for WashU DocuSign users. - Templates
Box
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.
- eRegulatory Management Using Box or Florence (July 2023)
This webinar discusses the pros and cons of the use of Box for eRegulatory Management as compared to a vended eRegulatory platform, Florence.
Resources
- WashU Box Cloud-Based Storage Standard Operating Procedure
This SOP applies to all active WashU faculty and staff engaged in research activities requiring electronic signatures for regulated study activities under Part 11. - Box Justification for Use Memo
Trial-CARE
- Trial-CARE Introduction to Part 11 (PDF)
This presentation by the Center for Clinical Studies provides an overview of CFR Part 11, and the requisites for researchers and their staff. You will learn how Trial-Care services for Part 11 can assist you in you in meeting compliance standards. - Investigator Responsibilities in 21 CRF Part 11 Regulated Research (PDF)
This guidance document pertains to the investigator’s responsibilities, support for investigators, and applicable references and resources. - eSignature Requirements for 21 CRF Part 11 Regulated Research (PDF)
This guidance document pertains to the levels of validation for eSignatures, procedure controls, support for investigators, and applicable references and resources.
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
Access Support
Trial-CARE
Trial-Coordination, Acceleration, and Recruitment Enhancement
trialcare@wustl.edu