Research Involving
- Investigational Devices
- Mobile Medical Applications
- Significant Versus Non-Significant Devices
- ChatGPT/ Large Language Models (LLM)/ Artificial Intelligence (AI)
Data Sharing
Data Security Risk Assessment and Data Transfer Agreement
A Data Security Risk Assessment by UCSF IT Security & Policy AND Data Transfer Agreement by the Office of Sponsored Research (OSR -- Industry Contracts Division) must be completed if your study involves: the collection, transmission, or storage of information when that data will be shared with or be accessible to any non-UCSF entity (e.g., pharmaceutical companies, UCSF Affiliated Institutions) or individual. This includes the use of third-party or vendor-hosted applications. UCSF or department-hosted applications may also need to be assessed in accordance with UCOP Policy IS-3 Electronic Information Security, particularly if they are new applications or have never been reviewed by UCSF IT Security & Policy.
- Third-party or vendor-hosted applications include cloud-hosted applications and applications hosted by collaborating institutions
- UCSF or department-hosted applications include any application managed by UCSF or developed by the department
These requirements apply for both identifiable and de-identified data for funded and unfunded research. Questions about these policies must be directed to UCSF IT and OSR, not to the IRB.
- To determine if a Data Security Risk Assessment is required, contact the intake team at [email protected]. More information about the assessment process is available at https://it.ucsf.edu/service/it-security-risk-assessment
- For information about Data Sharing Reviews: Visit https://data.ucsf.edu/data-sharing or email [email protected]
- For information about establishing contracts for data sharing engagements: Visit https://icd.ucsf.edu/material-transfer-and-data-agreements or email [email protected]
Versa
UCSF Versa – a UCSF IT-supported Artificial Intelligence (AI) ecosystem that connects AI tools with UCSF data and systems.
For initial applications:
- If the investigator expects to analyze data on the Versa platform, we’d like to know, but just so we have an idea of how widespread the use is.
- Not applicable to new aims
Already Approved Protocols Now Using Versa Platform:
- There is no need to submit a modification if the study is approved to collect and analyze Electronic Health Record (EHR) or Personally Identifiable
Resources
- FDA
- Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
- Is Your Clinical Decision Support Software a Device? The Clinical Decision Support Software guidance describes the regulatory approach to Clinical Decision Support (CDS) software functions. The decision tree offers a general and illustrative summary of this guidance.
- UCSF