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 […]
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.
Use of Legally Authorized Representatives
The State of Missouri has enacted legislation that outlines how research participants unable to consent for themselves may be enrolled in research studies.
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
Responsible Office: Office of the Vice Chancellor for Research, Office of Research Integrity and Ethics Office Contact: ORIE@wustl.edu Effective Date: January 1, 2026 (updated from 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 […]
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 […]