ICH-GCP E6(R2) Guidelines

Essential Documents are those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.

Human Embryonic Stem Cell Research Guidelines and Glossary

Created 12/18/2001 Revised 02/28/2008 I. Institutional Oversight II. Other Institutional Oversight III. ESCRO Scientific and Ethical Review of Proposed Research IV. Procurement of Gametes, Blastocysts or Cells for Human Embryonic Stem Cell Generation V. Adherence to Standards of Clinical Care VI. Standards for Investigators Who Wish to Bank Cell Lines VII. Other Applicable Washington University […]

Export Control Policy

Created 01/2013 Introduction and Purpose As part of its mission to create and transmit knowledge through research, education and patient care, Washington University strives to maintain a diverse and vibrant academic community that welcomes foreign researchers and encourages international collaborations for the general advancement of human knowledge. In its Policy on Open Research And Free […]

Storage and Security Guidelines

Created 08/20/2010 Investigators using controlled substances in research must take appropriate steps to safely store and secure the substances to prevent unauthorized access, use or diversion. This applies to the use of controlled substances when obtained under the Washington University registration or under an individual investigator registration. This document provides the key elements of an appropriately […]

Background Check Procedures

Created 03/2010Revised 07/2016 Controlled Substance Access Background Check Form Download the Background Check Form for Use of Controlled Substances in Laboratory or Animal Research. United States Drug Enforcement Administration Requirement “The registrant shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense […]

Research Integrity Policy

Created 10/18/2000 Revised 11/04/2010 Previous amendments to this policy made on 03/18/2002, 08/10/2007, 10/17/2008 Reviewed by: Faculty Senate Council, 9/7/2010 Approved by: The Executive Committee on Research, 11/4/2010 I.     Introduction II.    Definitions III.   Applicability IV.   Rights and Responsibilities V.    Allegations VI.   Organizational Structure VII.  Confidentiality VIII. Inquiry and Investigation A.  Initial Review of an Allegation B.  […]

Procedures for the Use of Controlled Substances in Laboratory and Animal Research​​​

Created 07/2010Revised 03/ 2016 I – Requirements for AcquisitionII – Institutional Animal Care and Use Committee (IACUC) ProtocolsIII – Background ChecksIV – DAF and DCM Stockroom ProceduresV – Controlled Substances InventoriesVI – Drug Storage, Records of Use & SecurityVII – DisposalVIII – AuditsIX – SanctionsX – Recordkeeping Requirements APPENDICES A – H A – Controlled […]

Policy for the Use of Controlled Substances in Laboratory and Animal Research

Created 07/08/2010Revised 03/2016 IntroductionScopeApplicable RegulationsResponsibilitiesSanctionsApproval Introduction and Purpose Certain drugs and chemical precursors fall under the jurisdiction of the Missouri Bureau of Narcotics and Dangerous Drugs (BNDD) and the US Department of Justice (DOJ) Drug Enforcement Administration (DEA). These drugs and chemicals are known as Controlled Substances and must be purchased, maintained, used and disposed […]