Determine if your project is clinical research or a Quality Assurance/Quality Improvement project.
Determine if your study is an Applicable Clinical Trial and learn how to register your study with the NIH ClinicalTrials.gov database.
Federal regulations for the FDA, Department of Health & Human Services.
Guidance for investigators who may need to submit an Investigational New Drug or Investigation Device Exemption application.
Education and training resources specific to Regulatory Support for members of the clinical research community.
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.
Guidelines for global pharmaceutical development and their regulation.
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..
A list of helpful organizations.
Resources for the IRB and other compliance services offered at Washington University.