G04 - [IN-PERSON/RECORDED] QA/QI for Non‐Clinical or Minimal Risk Research

This session will be offered in-person and recorded for on-demand access by in-person PRIMR23 attendees registered for this day, and PRIMR23/SBER23 Virtual Meeting registrants.

Many postapproval monitoring efforts focus on more than minimal risk clinical research. However, because most research monitoring efforts internal to institutions view study team audits as educational opportunities (as much or more than ensuring compliance), non-clinical researchers and investigators conducting minimal risk research may benefit from the feedback an audit can provide. This session will explore audit approaches that may benefit non-clinical researchers; tools that can be offered to assist study teams to conduct self-audits or provide check ins in the absence of formal monitoring (e.g., in the case of minimal risk research where continuing review may not occur); and how to tailor audits to be most helpful specific researcher populations, such as students, inexperienced researchers, or basic scientists.