Charges for your research participant's appointment are now based on level of clinical care received at each visit. No longer is the fee based solely on length of a participant's visit.

Level 1: Basic Clinical Services

Description – Choose up to five of the following: (Visits generally lasting up to 2.5 hours)

• Any visits lasting up to 2.5 hours
• Simple phlebotomy draw (adult or pediatric subject > 6 months of age) typically drawn by CTRC phlebotomist
• Simple vital signs and measurements (adult or pediatric) which includes blood pressure, heart rate, respiratory rate, temperature, height and weight by CTRC staff
• Complex vital signs by CTRC staff
• Orthostatic vital signs (lying, sitting, and standing) by CTRC staff
• Simple ECGs by CTRC staff
• Simple oral medication administration (one agent of "approved use", e.g., Tylenol) by CTRC nurse
• Specimens (e.g., blood, urine) collected offsite and requisitioned by CTRC to be sent to McLendon Lab by CTRC staff
• Point of Care (POC) urine pregnancy and/or urine dipstick testing by CTRC staff
• Single whole blood Point of Care (POC) glucose testing by CTRC staff

Level 2: Minimal Care

Description – Choose any level 1 care and up to three of the following: (Visits generally lasting 2.5 hours up to 4.5 hours)

• Any visits lasting longer than 2.5 hours but less than 4.5 hours
• Pediatric phlebotomy (hospital and/or study labs) for subjects less than or equal to 6 months of age by CTRC RN/LPN
• Complex vital signs (e.g. BP measured 3 times manually five minutes apart & BP measured 3 times by automatic device five minutes apart) by CTRC staff
• Simple pharmacokinetic sampling (e.g., blood sampling of up to 3 time points) by CTRC nurse
• Nasal, Oropharyngeal, or Throat swab collection by CTRC nurse
• Medication administration given - subcutaneous, intramuscular, or intradermal: single agent, non-study medication (e.g., medroxyprogesterone acetate, approved vaccine) by CTRC nurse
• Oral administration of a single investigational study product by CTRC nurse without PK sampling or observation time required
• Medication given by physician/licensed study staff or self-administered by a study participant and witnessed by a study coordinator, and post dose monitoring (e.g., vital signs, site assessment) performed by CTRC nurse
• Subcutaneous, intramuscular, or intradermal injection of study product administered by CTRC nurse with less than 2 hours observation by CTRC nurse
• Initiating and/or discontinuing intravenous access by CTRC nurse
• Accessing and/or de-accessing port-a-cath or other central line that includes line flush per UNC Health policy by CTRC nurse
• Central line dressing change with or without the required line flush per UNC Health policy
• Oral glucose or mixed meal tolerance test with up to 3 blood draws performed by CTRC nurse at different timepoints post oral glucose administration
• Procedures performed at bedside by LIP (e.g., lumbar puncture, pelvic exam, intrathecal injection, biopsy) with assistance from CTRC nurse (e.g., passing of instruments, subject positioning, observation)
• Questionnaires or scales given to subjects by CTRC nurse that require CTRC nurse to be present and assist subject with completion
• Participant or caregiver teaching (e.g., subcutaneous self-administration) by CTRC nurse
• Any other procedure not listed above that requires a CTRC nurse to assist with or to perform

Level 3: Moderate Care

Description – Visits generally lasting more than 4.5 hours but less than 6.5 hours and may include any Level 1 care, more than three Level 2 care, and/or up to one of the following:

• Visit lasting longer than 4.5 hours but less than 6.5 hours OR one of the Level 3 items below (cannot be selected in combination with any other Level 3 item)
• Visits lasting up to 6.5 hours requiring frequent data collection (e.g., vital signs, ECG) and/or frequent specimen collection by CTRC nurse (e.g., blood, urine, swab) at multiple time points throughout the visit
• Subcutaneous, intramuscular, or intradermal injection of study product administered by CTRC nurse with total visit length of more than 4.5 hours but less than 6.5 hours
• Visit lasting up to 6.5 hours without study product administered by CTRC nurse and requiring frequent data collection (e.g., vital signs, ECGs) and/or specimen collection (e.g., blood sampling, urine, swab) at multiple time points throughout the visit
• Visits lasting up to 6.5 hours and requiring administration of a single study product by any route (oral, intravenous, subcutaneous, intradermal, or intramuscular) with specimen collections no more frequently that every 30 minutes (e.g. blood sampling, urine, swab) and may include data collection (e.g. vital signs, ECGs) at several time points throughout the visit
• Visit lasting up to 6.5 hours and requiring administration of a single agent (oral, intravenous, subcutaneous, intradermal, or intramuscular) study product such as investigational drugs, biotherapy, or immunotherapy with specimen collections no more frequently than every 30 minutes (e.g., PK sampling, urine collection, swab collection) and may include other data collection (e.g., vital signs, pulse oximetry) at several time points throughout the visit
• Visit requiring frequent nursing interventions such as multiple dose adjustments of an intravenous study drug up to 1 hour and/or frequent monitoring (e.g., vital signs every 15 minutes over at least 1 hour)
• Visit lasting up to 6.5 hours in length and requiring administration of more than one study product (oral, subcutaneous, intradermal, or intramuscular) in any combination with specimen collection no more frequently than every 30 minutes (e.g., PK sampling, urine collection, swab collection) and may include other data collection (e.g., vital signs, ECGs)
• Procedures performed at bedside by LIP (e.g., lumbar puncture) that requires recovery or observation to be completed by CTRC nurse and that may include specimen collection and/or other data collection (e.g., frequent vital signs)
• Oral glucose or mixed meal tolerance test with more than 3 blood draws performed by CTRC nurse at different time points post glucose administration
• Medication given by physician/licensed study coordinator or subject self-administration, and post dose monitoring (e.g., vital signs, site assessment) performed by CTRC nurse with total visit length of more than 4.5 hours but less than 6.5 hours post dose

Level 4: Complex Care

Description: Visits generally lasting more than 6.5 hours but less than 8.5 hours, includes at least two Level 3 care, or includes one or more of the following and may include any combination of Level 1 or Level 2 care:

• Any visit that requires participant to remain on the unit for more than 6.5 hours but less than 8.5 hours
• Any visit requiring assistance of two CTRC licensed nurses at any time point for a minimum of 15 minutes
• Visit requiring intravenous administration of two or more medications including investigational products, electrolyte solutions, antibiotics, or any other intravenous medication
• Visit requiring intravenous administration of a single agent such as investigational medication, biotherapy, or immunotherapy with specimen collections more frequently than every 30 minutes (e.g., blood sampling, urine collection, swab collection) and may include other data collection (e.g., vital signs, ECGs) at several time points throughout the visit
• Visit requiring frequent nursing interventions such as multiple dose adjustments of an intravenous study drug over at least 1 hour and/or frequent monitoring (e.g., vital signs every 15 minutes over at least 1 hour)
• Visit requiring administration of more than one study product in any combination (oral, subcutaneous, intradermal, intravenous, or intramuscular) such as investigational product, biotherapy, or immunotherapy with specimen collections more frequently than every 30 minutes (e.g., PK sampling, urine collection, swab collection) and may include other data collection (e.g., vital signs, ECG)
• Pediatric participant < 16 years old requiring intravenous administration of investigational product or approved agent with or without simple PK sampling
• Visit lasting less than 6.5 hours with specimen collections more frequently than every 30 minutes (e.g., IVGTT) and may include other data collection (e.g., vital signs, pulse oximetry) at several time points throughout the visit
• Any visit requiring emergency interventions such as with a hypersensitivity or anaphylactic reaction that may necessitate the use of emergency medications, Rapid Response Team, a Code Blue, requires admission to UNC Medical Center or any visit that requires a nurse-to-patient ratio 1:1 for more than 30 minutes

Visits greater than 8.5 hours:

Description: Visits lasting more than 8.5 hours will be charged a Level 4 fee plus the current hourly fee (billed in 30-minute increments) for every hour thereafter.