Regulatory Support

Trained Nurse Coordinators can provide regulatory support from writing initial IRB applications through the completion of your trial.

Application Initiation
includes:  Complete IRB applications and consent forms, serve as liaison between sponsor and IRB, assist with posting approved protocols on UNMC Clinical Trials Database
$2,000

Coverage Analysis
Full review performed on clinical trials that generate technical/professional charges and modified review that do not. 
Contact Katie Penas (402-552-6601) to see if Coverage Analysis Fees apply to your project.

$750 full review
$200 modified review

 

Nursing Services

The Clinical Research Center (CRC) provides a wide-range of protocol related services including space and nursing expertise.  Due to the unique circumstances required; each project is budgeted for the time and materials that will be required.  Please contact the Nurse Manager, LuAnn Larson (402-559-8555), to ask for a protocol estimate.

CRC Clinical Laboratory

The CRC Clinical Laboratory provides the laboratory tests listed below.  The laboratory also develops custom tests for research protocols, please contact the laboratory manager, Claudia Borgeson (402-559-5086) to inquire.  Download the Laboratory Test Development Questionnaire.

25-Hydroxy Vitamin D +
Sample: Serum
Minimum collection requirements:  100 ul
Type of assay:  RIA
Assay sensitivity:  1.5 ng/mL

Cost/sample:  $49.00

Cross-Reactivity Steroid:
Vitamin D2 0.8%
Vitamin D3 0.8%
25-OH-D2 100%
25-OH-D3 100%
24,25-(OH)2-D2 100%
24,25-(OH)2-D3 100%
25,26-(OH)2-D2 100%
25,26-(OH)2-D3 100%
1,25-(OH)2-D2 2.5%
1,25-(OH)2-D3 2.5%
Normal Range (if applicable)  Mean:  23ng/mL (n=44)  Range:  9.0-37.6 ng/mL
Intra-assay variation  
Inter-assay variation  
Storage Requirements  -20° C up to one year, -80° C up to 3 years

Kit manufacturer and location:  DiaSorin
Assay References.

  1. Chesney, RW.  "Current Clinical Applications of Vitamin D Metabolite Research"  Clinical Orthopaedics and Related Research  161:285 (1981)
  2. DeLuca, HF and Schnoes, HK.  "Metabolism and Mechanism of Action of Vitamin D"  Annual Reviews Biochemistry  45:631 (1976)
Apo E Genotyping +
Sample: Whole Blood
Minimum collection requirements:  1 mL 
Type of assay:  Genotype Assay 
Assay sensitivity: 
Cost/sample:  $44.00
Cross-Reactivity  
Normal Range (if applicable)  
Intra-assay variation  
Inter-assay variation  
Storage Requirements  Extracted DNA or Whole Blood

Kit manufacturer and location: 
Assay References.

Bone Alkaline Phosphatase +
Sample: Serum
Minimum collection requirements:  200 uL
Type of assay:  EIA
Assay sensitivity:  0.7 Units/L

Cost/sample:  $40.00

Cross-Reactivity Alkaline Phosphatase Isozymes:
Bone 100%
Liver 3-8%
Placental 0%
Intestine 0.4%
Normal Range (if applicable) Premenopausal Women:  11.6-30.6 Units/L
Postmenopausal Women:  14.8-43.4 Units/L
Men:  15.0-41.3 Units/L
Intra-assay variation  3%
Inter-assay variation  2.9%
Storage Requirements  Stable for 1 week at 4° C or 1 year at -20° to -70° C

Kit manufacturer and location: Quidel (San Diego, CA) 
Assay References.

  1. Price, CP  "Multiple Forms of Human Serum Alkaline Phosphatase:  Detection and Quantitation"  Ann Clin Biochem  30:355-372 (1993)
Deoxypiridioline +
Sample: Urine
Minimum collection requirements:  1 mL
Type of assay:  EIA
Assay sensitivity:  1.1 nmol/L

Cost/sample:  $43.00

Cross-Reactivity Free Deoxypyridinoline 100%
Free Pyridinoline < 1% 
Deoxypyridinoline/Pyridinoline Peptides < 2.5%
Normal Range (if applicable) Mean: Healthy Premenopausal Women:  5.0 nmol Dpd/mmol Creatinine (n=312)
Mean: Healthy Men:  3.8 nmol Dpd/mmol Creatinine (n=12)
Intra-assay variation  
Inter-assay variation  
Storage Requirements  -20° C up to one year, -80° C up to 3 years

Kit manufacturer and location:  Metra Biosystems
Assay References.

  1. Seyedin, SM, Rosen, DM  "Matrix Proteins of the Skeleton"  Curr Opin Cell Biol  2:914-919 (1990)
  2. Delmas, PD  "Biochemical Markers for the assessment of Bone Turnover" in Osteoporosis:  Etiology, Diagnosis and Management, Riggs, BL, Melton LJ III (eds)  Philadelphia:  Lippincott-Raven Publishers, 319-333 (1995)
Direct Saliva Melatonin +
Sample: Saliva
Minimum collection requirements:  1 mL
Type of assay:  RIA
Assay sensitivity:  0.2 pg/mL

Cost/sample:  please contact the CRU laboratory for current pricing

Cross-Reactivity

Melatonin 100%
Serotonin 100%
5-Hydroxy-indoleacetic acide <0.001%
N-Acetylserotonin 0.0027%
5-Methoxytryptamine 0.003%
5-Methoxytryptophan 0.001%
6-Sulfatoxymelatonin 0.002%
5-Methoxytryptophol 0.001%
Methoxypsoralen <0.001%

Normal Range (if applicable)  
Intra-assay variation  
Inter-assay variation  
Storage Requirements  6 months at -20° C

Kit manufacturer and location: Buhlmann Laboratories AG (Switzerland) 
Assay References.

  1. Vaughn, GM  "New Sensitive Serum Melatonin Radioimmunoassay Employing the Kennaway G280 Antibody:  Syrian Hamster Morning Adrenergic Response"  J Pineal Res  15:88-103 (1993)
Estradiol +
Sample: Serum or EDTA Plasma
Minimum collection requirements:  100 uL
Type of assay:  RIA
Assay sensitivity:  4.6 pg/mL

Cost/sample:  $29.00

Cross-Reactivity  Estradiol-17ß: 100%
Estron:  0.2%
Estriol:  0.05%
Androstenedione:  0%
Androsterone:  0%
Cortisone:  0%
Epiandrosterone:  0%
16-Epistriol:  0%
Estradiol-3-sulfate:  0%
Estradiol-3-glucuronide:  0%
Estradiol-17α:  0%
Estriol-16-glucuronide:  0%
Estrone-3-sulfate:  0%
Dehydroepiandrosterone:  0%
11-Desoxycortisol:  0%
11-Desoxycorticosterone:  0%
21-Desoxycortisol:  0%
Dihydrotestosterone:  0%
Dihydroepiandrosterone:  0%
20-Dihydroprogesterone:  0%
11-Hydroxyprogesterone:  0%
17α-Hydroxyprogesterone:  0%
17α-Pregnenolone:  0%
17α-Progesterone:  0%
Pregnanediol:  0%
Pregnanetriol:  0%
Pregnenolone:  0%
Progesterone:  0%
Testosterone:  0%
Normal Range (if applicable) Premenopausal Women:  12-126 pg/mL
Menopausal Women: 11-64 pg/mL
Men: 10-36 pg/mL
Intra-assay variation  
Inter-assay variation  
Storage Requirements  -20° C

Kit manufacturer and location: IBL Immuno Biological Laboratories (worldwide) 
Assay References.

  1. Tsang, BK, Armstrong, DT and Whitfield, JF  "Steroid Biosynthesis by Isolated Human Ovarian Follicular Cells in-vitro"   J Clin Endocrinol Metab  51:2407-11 (1980)
  2. Gore-Langton, RE and Armstrong, DT  "Follicular Steroidogenesis and Its Control" in The Physiology of Reproduction, Knobil, E and Neil, J (ed) 331-385 Raven Press, New York (1988)
Glucose Analysis via YSI +
Sample: Plasma
Minimum collection requirements:  500 uL
Type of assay:  Glucose Analyzer
Assay sensitivity: 

Cost/sample:  $17.88

Cross-Reactivity  
Normal Range (if applicable) Fasting:  <100
Post Glucose or Random:  <200
Intra-assay variation  
Inter-assay variation  
Storage Requirements  -20° C up to one year, -80° C up to 3 years

Kit manufacturer and location:  Yellow Springs Instruments
Assay References.

hs C-Reactive Protein +
Sample: Plasma or Serum
Minimum collection requirements:  200 uL
Type of assay:  ELISA
Assay sensitivity:  0.124 ng/mL

Cost/sample:  $36.00

Cross-Reactivity Alpha-1-Antitrypsin:  0%
Lysozyme:  0%
Albumin:  0%
Other acute phase proteins:  0%
Normal Range (if applicable)

Normal:  <1mg/L
Borderline:  1-3 mg/L
High:  >3 mg/L

Intra-assay variation  2.3%
Inter-assay variation  0%
Storage Requirements  stable at 4° C for 1 week, at -20° C to -70° C for one year

Kit manufacturer and location:  Immunodiagnostik (Germany)
Assay References.

  1. Hoffler, D, Shah, P  "C-Reaktives Protein-die Diagnostische Reichweite"  Theime Verlag (1997)
  2. Mendall, M et al  " "  BMJ  349:462-466 (1996)
Human IL-6 +
Sample: Human Serum, Plasma (EDTA) or Cell Culture
Minimum collection requirements:  250 uL
Type of assay:  ELISA/EIA
Assay sensitivity:  <2 pg/mL

Cost/sample:  $40.00

Cross-Reactivity Human: (IL-1α, IL-1β, IL-2, IL-3, IL-4, IL-7, IL-8, IL-10, G-CSF, GM-CSF, IFN-γ, LIF, MIP-1α, MIP-1β, MCP-1, OSM, RANTES, TGF-β, TNF-α, TNF-β) 0%
Mouse/Rat IL-6:  0%
Normal Range (if applicable)  7.8-500 pg/mL
Intra-assay variation  
Inter-assay variation  
Storage Requirements Samples should be aliquoted to avoid multiple freeze thaws, and frozen at -20° C as soon as possible, IL-6 samples are stable at -70° C for at least one year

Kit manufacturer and location: ALPCO Diagnostics (Salem, NH) 
Assay References.

  1. Houssain, FA, et al  Arth Rheum  31:784-788  (1988)
  2. Moscovitz, H, et al  Critical Care Medicine  22:1102-1107  (1994)
  3. Sakamoto, K, et al  Cytokines  66:181-186  (1994)
LDL Subtype +
Sample: Serum
Minimum collection requirements:  500 uL
Type of assay:  Gradient Gel Electrophoresis 
Assay sensitivity: 

Cost/sample:  Please contact the CRU laboratory for current pricing

Cross-Reactivity  
Normal Range (if applicable)  
Intra-assay variation  
Inter-assay variation  
Storage Requirements  

Kit manufacturer and location: 
Assay References.

  1. O'Neal, D, Hew, FL, et al  "Low Density Particle Size in Hypopituitary Adults Receiving Conventional Hormone Replacement Therapy"  J Clin Eno Met  81, 7:2448-2454  (1996)
N-Telopeptide +
Sample: Serum
Minimum collection requirements:  200 ul
Type of assay:  EIA
Assay sensitivity:  3.2 - 40 nM Bone Collagen Equivalents (BCE)

Cost/sample:  $45.00

Cross-Reactivity  None listed
Normal Range (if applicable) Premenopausal Women:  6.2-19.0 NM BCE
Postmenopausal Women:  8.2-33.9 nM BCE
Men:  5.4-24.2 nM BCE
Intra-assay variation  3.7%
Inter-assay variation  0%
Storage Requirements  -70° C for 3 years

Kit manufacturer and location:  Wampole  (Princeton, NJ)
Assay References.

  1. Clemens, JD, et al  "Evidence that Serum NTx (Collagen-Type 1 N-Telopeptides) Can Act as Immunochemical Marker of Bone Resorption"  Clin Chem  43:2058-2063  (1997)
Total Insulin +
Sample: Serum or Plasma
Minimum collection requirements:  300 uL
Type of assay:  RIA
Assay sensitivity:  2 μU/mL

Cost/sample:  $16.00

Cross-Reactivity  Human Insulin:  100%
Lispro:  100%
Humalin:  100%
Aspart:  ?
Glargine:  ?
Intact Hu Proinsulin:  <0.2%
Des 31, 32 HPI:  <0.2%
Des 64, 65 HPI:  76%
Porcine Insulin:  100%
Dog Insulin:  100%
Bovine Insulin:  62%
Rat Insulin:  <0.1%
(Glucagon, IGF-1, Somatostatin, Pancreatic Polypeptide):  Not Detectable
Normal Range (if applicable)  Fasting:  5-15 μUnits/mL
Intra-assay variation  3.3%
Inter-assay variation  6%
Storage Requirements  -70° C for up to 3 years

Kit manufacturer and location:  Linco Research  (St. Charles, MS)
Assay References.

  1. Morgan, CR and Lazarow, A  "Immunoassay of Insulin:  Two Antibody System.  Plasma Insulin Level in Normal, Subdiabetic, and Diabetic Rats"  Diabetes  12:115-126  (1963)

Acknowledgement & Support

The Clinical Research Center (CRC) is administrated, operated, and supported through The Nebraska Medical Center and the Office of the Vice Chancellor for Research.

All users of the CRC are obligated to acknowledge the facility in formal publications and presentations which include data generated in the facility.  Please send reprints of such publications to the CRC Nurse Manager.

Training Opportunities
The staff of the CRC offer training to faculty and staff on a variety of clinical research topics.
  • Research Billing
  • Billing Matrix
  • Price Inquiry
  • Clinical Coordinator Workshops

Personalized training is always available.  Please contact Janet Davis in the CRC to inquire. 

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