Topic: Human Subjects Research

Epic Access for Non-Employees for Research Purposes

Washington University School of Medicine uses Epic as its electronic medical records (EMR) system. Access to Epic, and to the protected health information (PHI) it contains, is strictly governed by federal law and university policy. This page explains the process by which non-WashU employees may request access to Epic for research purposes. Who the Policy […]

REDCap Cloud & WashU REDCap

REDCap Cloud (RCC) for Part 11 Regulated Research Under FDA 21 CFR Part 11 (“Part 11”), eSignatures and electronic records must be managed in validated systems. REDCap Cloud (RCC) is a validated electronic data capture (EDC) platform that supports eConsent; surveys; and integration with EHRs, wearables, mobile apps, and other data sources. nPhase, Inc. is […]

NIH GCP Training Options

Learners are required to complete only one GCP course, and the NIH offers the following two options: National Institutes on Drug Abuse (NIDA) GCP Training course GCP for Social and Behavioral Research course Certificate of Completion To have your GCP course marked complete in Workday Learning, you must email your certificate to ovcrinfo@wustl.edu. Other GCP Courses […]

Workday Learning Transition from Learn@Work

All trainings are now in Workday Learning. General information about Workday Learning is available on the Workday Learning for Learners reference guide. Info sessions: Preparing for Workday LearningThis session provided a general overview of the transition and how research training functions in Workday Learning. Recording from April 14Presentation slides Reporting on Compliance Training in Workday […]

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 […]

Trainings for Researchers

Compliance Trainings Below are the major compliance trainings required for the research community. Most mandatory trainings are assigned in Workday Learning based on HR data or by the completion of the Compliance Profile. All members of the research community are encouraged to complete the compliance profile at the start of a new position or when job […]

Essential Regulatory Documentation

Purpose Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of Good Clinical Practice and all applicable regulatory requirements. Best Practice Considerations Templates Monitoring/Auditing […]