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.
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.
If you need additional assistance with your CTA Budget, contact:
MSC09 5220
1 University of New Mexico
Albuquerque, NM 87131-0001
Physical Location:
1650 University Blvd NE
Second Floor, Suite 2200
Phone: (505) 272-9383
Fax: (505) 272-0159
hsc-preaward@salud.unm.edu
Office Hours:
Monday - Friday: 8am - 5pm
