Regulatory Support

Resources for the administrative and regulatory compliance support of clinical research studies in accordance with HIPAA, ICH-GCP, and FDA guidelines.

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Assistance with Starting a New Project

Determine if your project is clinical research or a Quality Assurance/Quality Improvement project.

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Determine if your study is an Applicable Clinical Trial and learn how to register your study with the NIH database.

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Code of Federal Regulations

Federal regulations for the FDA, Department of Health & Human Services.

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Compliance with FDA Regulations

Guidance for investigators who may need to submit an Investigational New Drug or Investigation Device Exemption application.

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Education & Training

Education and training resources specific to Regulatory Support for members of the clinical research community.

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Human Subject Regulations Decision Charts

Decide if an activity is research involving human subjects that must be reviewed by an institutional review board (IRB) and whether informed consent or the documentation of informed consent can be waived.

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International Council for Harmonisation (ICH)

Guidelines for global pharmaceutical development and their regulation.

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Office of the Vice Chancellor for Research (OVCR)

The Office of the Vice Chancellor for Research (OVCR) website provides a consolidated source of information related to research administration, management, and compliance at WashU..

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Organizations & Societies

A list of helpful organizations.

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Regulatory and Compliance

Resources for the IRB and other compliance services offered at Washington University.

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Request Regulatory Support

Contact our regulatory specialists to request more information about the services that are currently offered.