Author: Danica

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 […]

FAQs – NIH Other Support

This Open Questions: NIH Other Support document contains a variety of FAQs and examples of how to list different scenarios in Other Support. (Requires WUSTL Key login to Box.)

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 WashU 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 care, […]

ORCID

ORCID IDs are unique, persistent digital identifiers that distinguish individual researchers. This enables transparent and trustworthy connections between researchers, their contributions, and their affiliations. ORCID ID Resources Becker Medical Library’s ORCID Subject Guide The Value of Using Unique Identifiers for Researchers (PDF) SciENcv SciENcv: Integrating with ORCID (NIH on YouTube)

SciENcv: Science Experts Network Curriculum Vitae

SciENcv is an application providing research profiles for all individuals who apply for, receive, or are associated with research investments from federal agencies. Faculty/key personnel must certify Common Forms in SciENcv. While delegates can enter data, faculty/key personnel must certify the document. Delegates can download certified documents. Create a SciENcv Account Faculty/key personnel: Research Administrators […]

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 […]