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 […]
Screening, Enrollment, and Master Log
Guide to Using the Screening & Enrollment Log (DOC) Screening & Enrollment Log Template (XLS)
LARS Project
Visit the LARS Project page.
FDA Audit Checklist
Download the FDA Audit Checklist: From Notification through Close-Out (DOC).
CIRC Disclosure Review Process
Effective: January 15, 2020Last Revised: September 28, 2023 Introduction The WUSTL Research Conflicts of Interest Policy states “The Conflicts of Interest Review Committee(s) (CIRC) is the designated official(s) responsible for evaluating financial disclosures.” This procedure outlines the process that the CIRC uses to evaluate the disclosures for financial conflicts of interest (FCOI). Disclosure Review All […]
Protocol Templates for Clinical Trials (NIH Templates for both biomedical and behavioral & social sciences research involving human subjects)
See NIH protocol templates for both biomedical and behavioral & social sciences research involving human subjects.
Deadline Date Timeline
Human Subjects Education and GCP Training Requirements Diagram
See the diagram on the differences between Human Subject Education and Good Clinical Practice training requirements in Box.
Continuing Review Policy
Includes secure content requiring login to view.
Start-up Company Guide
Navigating university collaborations, resources, and potential conflicts. Advice, Considerations, and Resources, outside of the tech transfer process, for faculty/staff when establishing or investing in a start-up company or pursuing STTR/SBIR funding or company sponsored funding for your lab. Introduction and Purpose The goal of this document is to provide guidance regarding general considerations associated with […]