Topics Covered by this Guidance Purpose This guidance outlines procedures for sharing both outgoing and incoming data at WashU, including the use of Data Transfer and Use Agreements (DTUAs). “Outgoing data” refers to an investigator sharing locally-created data with an outside party. “Incoming data” refers to an investigator receiving data from an outside party. Both […]
Topic: Research Data
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 […]
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 […]
CUI/Information Security
The WashU CUI project team is made up of individuals from throughout the university, reflecting the interdisciplinary nature of obtaining and maintaining an adequate Cybersecurity Maturity Model Certification (CMMC) level.
Securing Controlled Unclassified Information (CUI)
Controlled Unclassified Information (CUI) is information held by or generated for the federal government that requires safeguarding or dissemination controls pursuant to and consistent with applicable laws, regulations and government-wide policies. CUI may include research data and other project information that a research team receives or creates during the performance of a contract funded by […]
Individual Participant Data (IPD) Sharing Statement
The International Committee of Medical Journal Editors (ICMJE) requires that an IDP Sharing Statement be include in the ClinicalTrials.gov registration. Download the Guidance for Completing the IPD Sharing Statement on ClinicalTrials.Gov (PDF).