Download the Certification of Review of Consent Documents (DOC).
Topic: Human Subjects Research
Bookmark and Password Protect Scanned Informed Consent Documents
Download How to Bookmark and Password Protect Scanned Informed Consent Documents.
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
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).
Study Termination Visit
Download the Study Termination Visit Template (DOC).