Sponsored Projects Office (SPO)

MSC09 5220
1 University of New Mexico
Albuquerque, NM 87131-0001

Physical Location:
1650 University Blvd NE
Second Floor, Suite 2200

Phone: (505) 272-6264
Fax: (505) 272-0159

Clinical Trial Q & A

Here you can find answers to common questions about clinical trials (CTAs).  If you have a question that is not addressed here, please contact:

What Are Clinical Trials?

According to the Clinical and Translational Science Center, a clinical trials are "...generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol."  To learn more about clinical trials, click here to visit the CTSC website, or click here to view their frequently asked questions page.

Who Are The Protocol Registration System (PRS) Administrators?

The Protocol Registration System (PRS) Administrators for ClinicalTrials.gov are:

To see a list of organizations with PRS accounts, please visit the clinicaltrials.gov "PRS Orgs" page.

What Should I Include In My Pharma / Industry Sponsored Budget?

  • IRB review: $2,000 initial review, $750 subsequent review, $500 amendment review
  • Non-refundable start up fees (4-5k at least): for time spent by PI and clinical staff on IRB review paperwork, other regulatory document completion, trips to investigator meeting, protocol review time, etc (paid regardless of whether or not the contract/study goes forward). If sponsor won’t accept, try adding in coordinator/PI time for investigator meetings.
  • Payment upon execution of the contract – if you can negotiate it, for other start up type costs
  • Payment upon completion of study – do not tie this to a site visit, only to submission of all case report forms or data or termination of the study
  • Per patient costs (tests, supplies, labor, 1% PI effort) (this will translate into the per patient reimbursement or the reimbursement for completed case report forms as determined by the sponsor - see UH charges memo)
  • Payment for departments doing testing (e.g. Pathology, Radiology) – both the hospital fee and the professional fee
  • Screen failures payments
  • Unscheduled visit payments
  • 28% F&A on total costs
  • Document storage fees
  • Pharmacy fees (include a start up fee and then a fee/prescription)
  • Postage if needing to send things regularly to sponsor
  • Publication preparation costs
  • Investigator meeting time – for investigator and support staff ($750/per person, per meeting)
  • Regulatory/administration time (adverse event reporting, etc) ($750 per 6 months)
  • Remember: most time spent on studies is maintaining regulatory documents including review & submission of adverse events to HRPO – this adds up in a long term (1 year or more) clinical trial

Pricing contact info (see memo for more information)

  • Procedures: Contact Julie Alliman or Bonnie White
  • Professional fees & CPT codes: contact the director of the unit/department in which the procedures will be performed to get the correct CPT code and professional fees associated with the procedure
  • Wilda McDonough at Tricore does CPT codes for labs for the referral billing/guarantor numbers.

For more information on clinical trials, click here to visit the Clinical & Translational Science Center's "Understanding Clinical Trials" page.

Who Can Help With My Clinical Trial Budget?

For help with your clinical trial budget, contact:

What Are The Patient Care Rates For UNMH?

  • The cost of UNMH procedures on any federally-funded, investigator-initiated / research allocation committee (RAC) / internal, state-sponsored, or non-profit foundation agreements is 100% of the current Center for Medicare Services (CMS) rate.  The CMS rate is defined as 100% of the Medicare fee (including deductibles and co-insurance) that the hospital would receive if the service was performed for a Medicare beneficiary.
  • The cost of UNMH procedures on any industry-sponsored (pharma and for-profit) agreements is 140% of the CMS rate.

For more information, click here to view the full policy.