COVID-19 Tool Kit for Human Subjects Research

Released June 24, 2020Last updated: July 8, 2020 Because of the situation COVID-19 has presented us, there has been an increased need to ensure that we have clear explanations and documentation in the research record of protocol deviations and IRB-approved modified processes. For information regarding monitoring, please see the Human Subjects Monitoring Guidance. This toolkit has […]

Self-Audit Toolkit

Internally monitoring and self-auditing human research studies is a valuable way for researchers to ensure that participants’ rights, safety and welfare are protected and that the research is conducted in accordance with the approved research plan and documented according to best practices. The Key Elements for Monitoring Adherence (PDF) guides researchers in a holistic review […]

FDA Audit Checklist

Download the FDA Audit Checklist: From Notification through Close-Out (DOC).

RMS Incident Report Form

Download the RMS Incident Report Form in Box to submit unexpected behavior or other issues relating to the Research Management System (RMS).

Biohazard Stickers

Download the 1×2.58″ Biohazard Sticker Template (DOC). Download the 0.5×1.75″ Biohazard Sticker Template (DOC).

Running Note

Investigators and coordinators have found a running note to be an effective way to document interactions with participants. This document should be an ongoing record that is signed and dated as each entry is made. Items noted on this type of document are phone call conversations, items to watch for during the next study visit, […]