Submitting a Clinical Trial Agreement
Please note that clinical trial agreements (CTAs) go through a process distinct from other research contracts. Clinical trials are subject to review by the Office of Clinical Research. While all CTAs will pass through the AURA Agreements system as part of the contract review process, in most cases, the CTA is first submitted in the ARTEMIS system. Please refer to the Types of Clinical Trial-Related Agreements section below for more information on the submission process.
What is A Clinical Trial?
It is important to differentiate between research activities that are Clinical Trials vs. those that are Clinical Research. This distinction impacts both contract review and financial aspects of the projects, such as the applicable IDC rate. While the differences can be somewhat nuanced, the key elements to consider are:
1. Does the project meet the NIH definition of a clinical trial?
2. Is the research intended to influence treatment or behavior, or to gain foundational understanding of the topic?
A clinical trial is designed to answer specific questions about the effects or impact of particular biomedical or behavioral interventions, or uses information from the study in a manner that affects medical decision-making for the study subject.
The objective of clinical research is data gathering. While this type of research may involve a particular person or group of people or use materials from humans, the focus is more generalized (e.g., studying of mechanisms of human disease, improving diagnostic tools, etc.).
3. Where will the research activities be conducted?
Clinical trials are generally conducted in hospital space, while clinical research is generally conducted in laboratory space.
For additional guidance in determining whether a study is a clinical trial, please contact URA.
Types of Clinical Trial-Related Agreements
Expand the applicable category below to determine the appropriate path to route the agreement to URA for review (i.e., whether ARTEMIS or AURA is the system of origin). A category description, additional tips and information, business process guidance, and IDC rate details are also included under each category.