FAQ

Agreements

I will be conducting a clinical research project. What type of agreement do I need and where do I start when…

The project is a clinical trial, or device study, or drug study?

Start here: Industry-Sponsored Clinical Trial for Review

The project involves an affiliated hospital?

The determining factor is whether ULRF’s direct sponsor is federal or nonfederal.

Start here:

The project involves human materials?

Start here: Industry-Sponsored Clinical Trial for Review

An industry or nonprofit partner is sponsoring the project?

Start here:

An industry or nonprofit partner is sponsoring the project, but the federal government is the primary sponsor?

Start here: Proposal Clearance Form (PCF) and Clinical Attachment

The federal government is funding the project directly?

Start here: Proposal for a Clinical Project Funded Directly by the Federal Government

Mine is an investigator-initiated project?

Start here: Industry-Sponsored Clinical Trial for Review


Who handles my agreements?

See list of Negotiator-Grants and Contracts Assistant teams by department.

Clinical Trial

What is the definition of a clinical trial for purposes of proposal submission?

Research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

ClinicalTrials.gov

ClinicalTrials.gov Registration

ClinicalTrials.gov Registration