Two primary sets of regulations govern the export of controlled technologies: the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations (EAR). The ITAR, which are administered and enforced by Department of State through its Directorate of Defense Trade Controls (DDTC), regulate the export of military, space, and satellite technologies. The EAR, which are administered and enforced […]
Category: How-Tos
Define “U.S. Person” vs. “Foreign National”
A “U.S. Person” is defined as a: Lawful Permanent Resident U.S. Citizen Legal Immigrant with a “Green Card” Protected Individual granted asylum or refugee status “Foreign National” includes everyone else, including foreign governments or entities not incorporated to do business in the U.S.
Determine When Export Control Laws Apply
What is export control? Export control laws regulate the export of commodities, related technical data and information, and certain services the federal government considers critical to the national security or domestic economy of the United States. The export control laws also regulate the transfer of controlled technical data to foreign nationals within the United States (“deemed exports”). “Exports” are […]
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, […]
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.
Bookmark and Password Protect Scanned Informed Consent Documents
Download How to Bookmark and Password Protect Scanned Informed Consent Documents.
Guide to Developing a NIH RCR Plan
For Institutional Training and Career Development Programs such as T32, T34, T90/R90, TL1, K12, K30 Download the RCR Plan Worksheet (PDF). Purpose This RCR Plan Worksheet is meant as a guide to help Washington University investigators develop appropriate RCR education plans in compliance with current NIH requirements. Individual Principal Investigators are responsible for developing, implementing, monitoring, and […]
Develop RCR Programming
There are many resources available to help in developing RCR educational programming. Below are internal resources and resources recommended by funding agency. For general resources, visit Resources on the Web. National Institutes of Health (NIH) Beginning January 25, 2010, the NIH requires RCR education plans to be submitted with all new and renewal applications for NIH-funded programs supporting […]
Award Document Quick Guide
For information about the intake process and what contract negotiators need from departments before they can process agreements, download the award document quick guide (PDF).