NICE Reviews

NICE – New Investigation Consult and Education

Get research compliance feedback on proposed study documentation and processes, after IRB approval, but before subject enrollment. NICE Reviews are designed primarily for non-IND/IDE, investigator-initiated studies.

NICE Reviews are:

• Practical. They provide straightforward “nuts and bolts” information and specific recommendations.
• Pro bono. They are voluntary and available at no cost.
• Proactive. They help avoid problems before they develop.
• Painless. They will be conducted based on your needs and within your time frame. We can come to your site, or we can review your materials at our office.

NICE Reviews are particularly helpful for:

• New investigators or coordinators,
• Investigators without study coordinators,
• Staffers wanting assistance with study setup before enrollment begins.

For more information or to schedule a NICE Review, contact the Research Compliance office.