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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.
NIH Policy on the Responsible Conduct of Research
Release date: November 24, 2009 (NOT-OD-10-019) Last update: February 17, 2022 (NOT-OD-22-055) The NIH Policy on Instruction in the Responsible Conduct of Research (RCR) provides specific requirements for RCR education plans, including ongoing monitoring and reporting on the fulfillment of the plans. For access to Washington University RCR resources, please visit the Responsible Conduct of […]
External Audits, Inquiries, Inspections & Unannounced Visits
Human Subjects Education Policy
Export Management and Compliance Plan
Created 01/2017 Updated 1/5/2022 Download the Export Management and Compliance Plan (PDF).
Electronic Storage of Human Research Study Documents
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 […]
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 […]