Clinical Trials

This section will provide answers to common question about clinical trials (CTAs).  If you have a question not addressed here, please contact:

A Clinical Trial, as defined by NIH, is a 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.  This definition also applies to Pharma related trials in which pharma companies evaluate the safety and efficacy of their developed drugs/devices.  These studies are a necessary requirement to achieving regulatory approval so the drugs/devices can be made available to patients.

What is a Clinical Trial?  How do they get initiated?  How do I get one processed? View the presentation below for guidance.

Clinical Trial Guidance

Ever wondered what SPO looks for while negotiating your clinical trial?  The guide below is to help assist with the understanding of what goes into negotiating a clinical trial and why UNM Health Sciences cannot accept certain terms and conditions.

CTA Presentation

Additional Information regarding Federal Clinical Trials can be found here: https://grants.nih.gov/policy/clinical-trials/definition.htm

Additional Information regarding ALL Clinical Trial Research can be found here:  https://www.fda.gov/patients/learn-about-drug-and-device-approvals

Clinical Trial Budget

The attached will describe the main costs associated with clinical trials and what must be included.  SPO does not negotiate clinical trial budgets.  This is done by the PI directly with the sponsor.  SPO does not have the in-depth clinical knowledge to accurately represent what the PI needs.  SPO DOES negotiate the Clinical Trial Agreement by reviewing for a safe and fair agreement.

CTA Budget

If you need additional assistance with your CTA Budget, contact: