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).
Certification of Review of Electronic Files Research Consent Documents
Download the Certification of Review of Consent Documents (DOC).
Bookmark and Password Protect Scanned Informed Consent Documents
Download How to Bookmark and Password Protect Scanned Informed Consent Documents.
Use of Legally Authorized Representatives
The State of Missouri has enacted legislation that outlines how research participants unable to consent for themselves may be enrolled in research studies.
Investigational Drug/Device Accountability Policy
Good clinical research practice requires that investigators and research teams insure accurate accountability for any investigational drug or device used in a research trial.
FDA Part 11 Certification
WashU School of Medicine has submitted our certification letter to the FDA indicating that the WashU owned clinical applications are FDA Part 11 Compliant.
Guidance for Disposal of Drugs Used in Clinical Research
Created 2011 Expectation Any used or unused investigational medications are to be destroyed in accordance with Federal Resource Conservation and Recovery Act (RCRA) guidelines and with standards set up by industry sponsors. Used refers to study medications used in clincal research dispensed to research participants and returned to research team. Unused refers to study medications […]