The State of Missouri has enacted legislation that outlines how research participants unable to consent for themselves may be enrolled in research studies.
Category: Policies, Procedures and Guidelines
This list includes all policies, procedures and guidelines related to a research topic.
View a list of key university-wide research policies, procedures and guidelines.
Investigational Drug/Device Accountability Policy
Good clinical research practice requires that investigators and research teams insure accurate accountability for any investigational drug or device used in a research trial.
FDA Part 11 Certification
WashU School of Medicine has submitted our certification letter to the FDA indicating that the WashU 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 […]
Protections from Retaliation for Participation in Research Misconduct Proceedings
December 10, 2010 Washington University expects all members of the research community to report observed instances of research misconduct and will take steps to assure the confidentiality of those reporting. Washington University has no tolerance of retaliation against individuals participating in a research misconduct proceeding. Please refer to the Rights and Responsibilities of individuals involved in a […]
Annual & Ongoing Review Process
General RC/SSF operating principles should be evaluated on an ongoing basis to help ensure the following general RC/SSF facility best practices are applied. Again, the policies will be helpful in this evaluation and can be found on the Financial Services website. These include: Rate Reviews Recharge centers operate on a Washington University fiscal year basis, with rates […]