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 […]
Topic: Human Subjects Research
FDA Audit Checklist
Download the FDA Audit Checklist: From Notification through Close-Out (DOC).
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.
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.
Clinicaltrials.gov 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 ClinicalTrials.gov […]
Individual Participant Data (IPD) Sharing Statement
The International Committee of Medical Journal Editors (ICMJE) requires that an IDP Sharing Statement be include in the ClinicalTrials.gov registration. Download the Guidance for Completing the IPD Sharing Statement on ClinicalTrials.Gov (PDF).
Accelerating Clinical Coordinator Excellence (ACCE) Program
The ACCE Program promotes excellence and professional development for clinical research professionals.
Clinical Trials Registration and Informed Consent Posting Guideline
Created 2005 Administratively Revised 01/2019 Last Revised 11/2019 WashU Guideline on Clinical Trials Registration Using Clinicaltrials.gov 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 WashU efforts to support the requirement to register clinical trials in […]
Certificates of Confidentiality (CoCs)
Created 08/21/2018Revised 09/09/2022 | Administrative update 09/09/2025 CoCs protect the privacy of research participants by prohibiting the research team from disclosing identifiable, sensitive research information to individuals or entities not connected to the research. CoCs are to be issued for any biomedical, behavioral, clinical, or other research, in which identifiable, sensitive information is collected where […]