The State of Missouri has enacted legislation that outlines how research participants unable to consent for themselves may be enrolled in research studies.
Author: Bryan
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 […]
Confidentiality Agreement (CDA)
Download Confidentiality Agreements: One-Way Confidentiality Agreement (DOC) Mutual Confidentiality Agreement (DOC) The proper contact to assist with Confidentiality Agreement (CDA) processing depends on the purpose of the confidential discussions. If a CDA is needed to discuss a potential research project or service arrangement, contact ResearchContracts@wusm.wustl.edu. If a CDA is needed to discuss a potential […]
At-Risk Requests
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Award Document Quick Guide
For information about the intake process and what contract negotiators need from departments before they can process agreements, download the award document quick guide (PDF).
Distinguish Between Agreement Types
Clinical Trial Agreement (CTA) or Clinical Research Agreement (CRA): An agreement directly with a for-profit company providing funding or a drug/device for a Clinical Trial Can be for a Sponsor-Initiated or Investigator-Initial Clinical Trial. Collaboration Agreement: An agreement covering an unfunded collaboration where both WU and the other party are contributing to the performance of a research scope of work. This can […]