Topic: Human Subjects Research

FDA Part 11 Certification

Washington University School of Medicine has submitted our certification letter to the FDA indicating that the Washington University owned clinical applications are FDA Part 11 Compliant.

Guidance for Disposal of Drugs Used in Clinical Research

Created 2011 Expectation Any used or unused investigational medications are to be destroyed in accordance with Federal Resource Conservation and Recovery Act (RCRA) guidelines and with standards set up by industry sponsors. Used refers to study medications used in clincal research dispensed to research participants and returned to research team. Unused refers to study medications […]

Good Clinical Practice Policy

Created 03/07/2017Revised 10/05/2017Administratively Revised 4/30/2019 Washington University Education in Good Clinical Practices I.     PurposeII.    PolicyIII.   Definition of a Clinical TrialIV.    ApplicabilityV.     Educational RequirementsVI.    FrequencyVII.   Effective DateVIII.  Frequently Asked Questions I. Purpose Washington University in St. Louis is committed to assuring the safety, integrity and quality of clinical trials as part of its mission to foster excellence in […]

Reporting Results on Clinicaltrials.gov

Created 06/2009 All studies, other than Phase I studies, that are interventional*, include a drug, device, or biologic, have at least 1 site in the U.S., and were ongoing after 9/27/07 MUST report results of the trial on clinicaltrials.gov. Investigators are required to report results within 12 months of the primary completion date** of the […]

Training

Download the Training Template (DOC).