RMS Post Submission Checklist

This Post RMS Submission Checklist is a collection of several tasks to complete in RMS after submitting to a sponsor.

FAQ – Research Data & Materials Policy

Visit the Research Data & Materials Policy to review the full policy. What are the reasons for the policy? The university is committed to high-quality research and academic integrity, which requires that stewardship of research data be handled in a thoughtful manner. Accurate and authenticated data records is critical for supporting and substantiating research findings, […]

Research Data and Materials Policy

Original Effective Date January 10, 2023 Washington University (WashU) deems appropriate stewardship of research data as fundamental to high-quality research and academic integrity. It therefore seeks to attain high standards in the generation, management, retention, preservation, curation, and sharing of research data. Recording and maintaining accurate and appropriate research records is necessary for the following […]

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 […]

Disclosure of Human Data Policy (School of Medicine)

Sharing human data with third parties for research and technology development has potential to accelerate biomedical research and advance science in support of the missions of Washington University and our affiliated hospital partners, BJC Health Care (BJC) (collectively, the “Institutions”). Data from patients and research participants are used in the hopes of advancing knowledge, improving […]

HRPO Policies, Procedures, & Guidance

The Human Research Protection Office (HRPO) offers Guidance for human studies research, including policies and guidance materials. These resource include HRPO’s Research Guide and Washington University IRB Policies, and additional resources. The HRPO Digital Commons hosts educational resources such as publications, presentations, and podcasts related to human subjects research and human research protections. The HRPO […]

Placement of Research Study Information & Consents in the Medical Record

This Washington University School of Medicine policy outlines how information from research studies/trails and research consent forms are to be documented in Epic (the electronic patient medical record). WUSM Policy: Placement of Research Study Information & Consents in the Medical Record (PDF)

Research Data/Record Retention Requirements

Record Retention Requirements Research data that are commonly accepted in the scientific community as necessary to validate research findings must be retained by WashU researchers for a minimum period required by applicable laws and regulations, funding agency requirements, or other agreements. The University and the Principal Investigator have rights and responsibilities concerning access to, use […]