Regulatory Support
Resources for the administrative and regulatory compliance support of clinical research studies in accordance with HIPAA, ICH-GCP, and FDA guidelines.
Assistance with Starting a New Project
Determine if your project is clinical research or a Quality Assurance/Quality Improvement project.
ClinicalTrials.gov Study Registration
Determine if your study is an Applicable Clinical Trial and learn how to register your study with the NIH ClinicalTrials.gov database.
Compliance with FDA Regulations
Guidance for investigators who may need to submit an Investigational New Drug or Investigation Device Exemption application.
Education & Training
Education and training resources specific to Regulatory Support for members of the clinical research community.
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.
International Council for Harmonisation (ICH)
Guidelines for global pharmaceutical development and their regulation.
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..
Regulatory and Compliance
Resources for the IRB and other compliance services offered at Washington University.
Request Regulatory Support
Contact our regulatory specialists to request more information about the services that are currently offered.