Category: Policies, Procedures and Guidelines

Created 03/2013Revised 09/2022 The nature and number of research protocols at Washington University has created a large volume of research study documents (including, but not limited to informed consent documents, case report forms, source documents, and study correspondence). The University recognizes the challenges and costs in storing physical copies of these documents for long periods […]

The State of Missouri has enacted legislation that outlines how research participants unable to consent for themselves may be enrolled in research studies.

Good clinical research practice requires that investigators and research teams insure accurate accountability for any investigational drug or device used in a research trial.

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.

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 […]

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 […]