Monitoring Guidance and FAQs

See also: COVID-19 Monitoring Guidance Approved: June 24, 2020 Purpose and Applicability Guidance Centralized Monitoring or Remote Monitoring On-Site Monitoring Monitoring of Multi-Centered PI-Initiated Trials Frequently Asked Questions (FAQs) Resources I. Purpose and Applicability Monitoring procedures have evolved in recent years due to advancements in technology.  Washington University in St. Louis is committed to supporting […]

CIRC Disclosure Review Process

Created 01.15.2020 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 covered individuals are required to submit […]

Continuing Review Policy

Created 05/28/2019 Policy Statement Continuing review of USDA species protocols must be completed annually. PHS funded studies must be reviewed once every three years. The IACUC will complete more frequent continuing review if required by the funding agency supporting the animal use protocol (Department of Defense, VA, etc.). If the required continuing review is not […]

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 […] Registration and Results Disclosure Policy

Chancellor Approved 2/18/2019 Position Statement WU requires the registration and disclosure of results for clinical research studies in accordance with applicable law and NIH policy. In addition, this policy recognizes International Committee of Medical Journal Editors (ICMJE) recommendations to register clinical trials and the Center for Medicare and Medicaid Services (CMS) requirements for a […]

Individual Participant Data (IPD) Sharing Statement

The International Committee of Medical Journal Editors (ICMJE) requires that an IDP Sharing Statement be include in the registration. Download the Guidance for Completing the IPD Sharing Statement on ClinicalTrials.Gov (PDF).

Clinical Trials Registration and Informed Consent Posting Guideline

Created 2005 Administratively Revised 01/2019 Last Revised 11/2019 Washington University Guideline on Clinical Trials Registration Using and Consent Form Posting Requirements Washington University in St. Louis is committed to the public dissemination of the results of research conducted by its faculty. This guideline describes Washington University efforts to support the requirement to register clinical trials […]