Topic: Human Subjects Research
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.
Electronic Storage of Human Research Study Documents
Created 03/2013Revised 09/2022 The nature and number of research protocols at Washington University has created a large volume of research study documents (including, but not limited to informed consent documents, case report forms, source documents, and study correspondence). The University recognizes the challenges and costs in storing physical copies of these documents for long periods […]
Certification of Review of Electronic Files Research Study Documents
Download the Certification of Review of Study Documents (DOC).