CITI offers the following trainings to anyone with a WashU Key: See the CITI Program quick guide for step-by-step guidance on creating an account, taking a course, and transferring training from another institution. Visit support.citiprogram.com for additional information on completing courses in CITI. Questions? See the diagram on the differences between Human Subject Education and […]
Topic: Human Subjects Research
External Audits, Inquiries, Inspections & Unannounced Visits
Human Subjects Education Policy
Determine if Your Trial Needs to Be Registered on Clinicaltrials.gov
Which trials are required to be registered by law? The law states that an applicable clinical trial generally includes (1) Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation and (2) Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, […]
Research Participant Registry
Clinicaltrials.gov
myIRB
Click here to go to myIRB.
Register a Trial on Clinicaltrials.gov
Learn how to register a trial on clinicaltrials.gov.
Include Informed Consent Document Language for Registered Clinical Trials
For all registered clinical trails approved on or after March 7, 2012, the following language must be included in the informed consent document per FDA regulations.
Billing Matrix
The Matrix was developed as a tool to identify clinical study participants and to serve as a potential roadmap to direct clinical trial billing activities.