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Facilities and Resources
The General Clinical Research Center (CRC) at the University of Chicago provides skilled research nursing, laboratory, and dietary support on its discrete 8-bed inpatient, 4-bed outpatient facility, and supports bed costs and/or ancillary services for various categories of research subjects.

The facility is located on the fifth floor, W corridor, of the Gilman-Smith wing of the University of Chicago Hospitals. At the north end of the unit, the W-5 corridor adjoins the Arthur Rubloff Intensive Care Tower and the Bernard Mitchell Hospital, the two major adult inpatient facilities of the University of Chicago Hospitals.

The W-5 wing is also conveniently located with respect to the academic offices and outpatient clinics of most of the faculty users of the unit, all under a single roof.

The unit, which encompasses a total of approximately 4,160 square feet, includes the following:

  • six private and 1 semiprivate inpatient rooms, for a total of 8 beds (when not occupied by inpatients, these rooms are frequently used for outpatient testing);
  • one suite of adjoining spaces for outpatient use, with 4 beds for procedures plus 2 phlebotomy chairs;
  • a centrally located nursing station with Hospital computer terminal, tube station and other standard amenities;
  • a Core Laboratory plus a sampling room from which blood can be drawn through portholes into the 2 adjoining inpatient rooms;
  • a fully equipped metabolic kitchen;
  • a sleep recording and analysis room with light-blocking shades, and video monitoring and taping capability; and
  • a conference room with seating for about 12 people.

Specialized equipment available to conduct research under CRC auspices includes:

  • Yellow Springs Instruments model 2300 "point-of-care" glucose meters;
  • Accutor automated blood pressure monitors;
  • A digital strain gauge;
  • Infusion pumps;
  • Stadiometers; and
  • Pulse oxymeters.

The unit is set up for 24-hour remote blood sampling and rapid sampling protocols. Many additional services and capabilities are available by cooperative arrangement, such as bone mineral densitometry, sleep polysomnography and scoring, and through several other center and program project grants at the University of Chicago, a wide variety of specialized laboratory determinations.

The CRC also makes space and support services available for faculty to conduct research initiated and sponsored by pharmaceutical or other biomedical industries.

The terms of our grant require that we recover all costs of supporting such research and that the industrial concerns cover all hospitalization and ancillary expenses through contracts with the faculty investigators. Please contact the CRC administrative office at (773) 702-6980 for further details.

Patient Care
The patient care staff of the Clinical Research Center includes two patient care managers, Julie Helms, BSN, RN, and Lynda Bartlett, BSN, RN, 8 staff nurses, 4 patient care technicians (PCTs), 1 patient service coordinator, and 2 patient service assistants. The patient care managers are responsible for scheduling patient admissions, supervising daily unit operations, and working with Hospital auxiliary departments to ensure smooth and consistent operation of the unit.

All of the staff nurses are registered nurses specially trained to carry out complex and diverse research procedures. They work to develop nursing outlines for the protocols, create flowsheets for the individual procedures and tests, and assist in data collection and general implementation of the studies. In addition, the staff nurses are responsible for subject/patient teaching, act as liaisons between the subjects and investigators and assure that signed informed consent has been duly obtained.

The RNs as well as the PCTs are knowledgeable in the use of equipment frequently employed in carrying out CRC protocols, such as the Yellow Springs Instruments bedside glucose analyzer, computerized infusion pumps, Miniprep slidemakers, microfuges, and electrocardiograms. The CRC patient care staff is skilled at peripheral IV insertion as well as Porta-Cath access for oncology patients requiring chemotherapy, and performs precise collections of blood, urine, stool, or other specimens at designated time points. The PCTs perform single-stick phlebotomy, monitor vital signs, and perform respiratory treatments, EKGs, and similar procedures.

Although a number of protocols call for polysomnography, the CRC does not have a sleep-EEG technician, and investigators requiring sleep or other EEG monitoring must provide their own staff . The CRC has video observation capability in 4 inpatient rooms. If an investigator requires other special monitoring, if the equipment can be moved to the CRC, and its use is straightforward, our own staff can be trained in its use. Otherwise, investigators may be asked to provide specialized technical staff to carry out unusual procedures or techniques.

One of the 8 staff nurses, Jacqueline Imperial, R.N., is permanently assigned to the outpatient unit. She schedules subjects independently from inpatient operations.

The inpatient unit is staffed 7 days a week, 24 hours a day; the outpatient suite is open Monday through Friday, and as needed over weekends.

For more information, please contact Julie Helms or Lynda Bartlett at (773) 702-6977.

Nutrition/Dietary Unit
An understanding of nutrition and nutrient metabolism is vital to many types of research protocols. In some studies, nutrition-related variables are the main concern, in others nutritional factors are a part of the metabolic background and must be held constant. The CRC has the staff and facilities to support a wide range of nutrition-related research needs.

Available services range from simple, convenient food service for study subjects to expert planning, implementation and monitoring complex metabolic balance studies. Computerized nutrient analysis is used both to evaluate subjects' nutrient intake and to plan study diets that meet exact specifications. A variety of measurement techniques are available to assess the nutritional status, estimate the nutrient needs, or evaluate the dietary habits of study participants. A fully equipped metabolic kitchen is available within the CRC, dedicated to the preparation, storage and dispensing of precision study meals.

The Nutrition Unit's professional staff consists of a Research Nutrition Manager, Jennifer Kilkus, R.D., L.D.N and three full time Registered Diet Technicians, Gayle Averyheart, Rosemary Burson, and Rowena Marks.

Jennifer assists investigators in planning and conducting the nutritional components of protocols, including literature review, protocol writing, data collection and organization, and reporting of results. She is experienced in the use of specialty computerized nutrient databases, as well as spreadsheets and other data management software. She maintains an extensive library of patient education materials, and is available to educate and counsel study participants on nutrition-related matters. In addition to meeting the food service needs of the Clinical Research Center, the Diet Technicians assist with data collection, diet analysis, and nutrition teaching.

Jennifer Kilkus can be contacted by phone/voicemail at (773)702-3012.

The Core Laboratory of the CRC
The CRC Core Laboratory is located in the center of the W-5 patient care unit, in room W-547. An additional room in W-516 houses more benches, a small office, and a large -80 degree freezer.

The lab is is staffed by chief technologist Su Yang, Ph.D. and one medical research technician.

The lab offers specimen processing for blood, urine, saliva and stool. Cortisol and progesterone assays are performed using radioimmunoassay methodology. Manual DNA extraction and lymphocyte isolation are also performed. The Core Lab is greatly expanding services related to human genetic and molecular biologic research, and welcomes inquiries from investigators.

One quarter each year, Sujata Patel teaches a 3 credit-hour course for University of Chicago undergraduates, "Laboratory Fundamentals in Clinical Research".

Please feel free to stop by the Core Lab for more information, or contact Su Yang, Ph.D. , the lab telephone number is (773) 702-6981.

Biostatistical Support
All protocols submitted to the CRC are reviewed by our biostatistician, Theodore Karrison, Ph.D., whose major responsibility is to ensure that the research conducted in the CRC is based upon a valid study design and that the data are properly analyzed and interpreted. The major areas of concern and questions raised during the initial statistical review of each protocol include the following:

Study Design

  • Are the objectives and hypotheses clearly stated? What are the primary outcome measures upon which the hypotheses are based? Are there secondary questions/outcome measures of interest?
  • What type of study is it (experimental, observational, pilot)? Whenever feasible, a comparative experiment incorporating a placebo or concurrent control group is recommended. In a nonrandomized comparison, will the different groups be matched with respect to important confounding factors and, if so, are the matching criteria clearly specified? If a crossover study is proposed, a major issue to be resolved is whether carryover effects can be ruled out.
  • Formal randomization using a table of random numbers is the method of choice in the allocation of subjects to treatments in experimental studies. If possible, the patients and investigators should also be kept blinded to the assigned treatments.
  • Sample size: will sufficient numbers of subjects be recruited to provide adequate power to detect clinically meaningful effects? Small pilot studies are acceptable, but they should be adequately justified and their limitations recognized.

Patient Selection Criteria

  • What is the source of patient recruitment?
  • Are the criteria for inclusion and exclusion of subjects clear, and will the results be generalizable to the intended target population?
  • Will the gender and racial composition of the study participants reflect the prevalence of disease in the U.S. population?

Protocol

  • Are the treatment or other interventions clearly described and are the procedures and schedules for data collection unambiguous and uniform across the different study groups?
  • Does the protocol pay sufficient attention to the issue of dropouts? Specifically, will steps be taken to minimize dropouts and, whenever feasible, will data continue to be collected on all patients enrolled in the study so that an intent-to-treat analysis can be performed?

Data Analysis

  • Are the statistical methods appropriate for the design of the study? Will the analyses adequately address the stated objectives and hypotheses?
  • Are the assumptions of the proposed analyses likely to be satisfied?
  • Are multiple comparisons planned and, if so, will appropriate allowances be made?
  • What are the response variables (outcome measures)? If more than one, can they be divided a priori into primary and secondary endpoints?
  • Are there important covariates or blocking factors that should be accounted for in the analysis to remove bias or improve precision?

The biostatistician meets with the principal investigator of each proposed study, raises questions, and, if needed, suggests areas in which the design or proposed data analyses could be strengthened. A written critique is prepared and discussed at the monthly Advisory Committee meetings along with those of the other reviewers. Thus, the statistical aspects of each protocol are given careful scrutiny and are taken into consideration by the full Advisory Committee in deciding whether to approve a new protocol.

Once a protocol has been approved, the biostatistician is available on an ongoing basis for further consultation by the investigative team. This may include direct participation in the analysis, depending upon the capabilities of the investigators and the complexity of the statistical methods required.

In addition to providing assistance in study design and analysis, the biostatistician advises CRC researchers on data management and statistical computation. He also teaches the biostatistics module of the Essentials of Patient Oriented Research course offered through the institution's Clinical Research Training Program. Click the following link to learn more about  data collection and recording guideline

Statistical Genetics
Judith Badner, M.D., Ph.D., serves as the CRC's statistical geneticist. In addition to reviewing all protocols involving investigations into heritable conditions and disorders, she will be available to provide investigators with the specialized support required for such studies.

The Informatics Core
The Informatics Core has the responsibility of ensuring that scientific and demographic data flowing between the CRC and the investigators are of the highest quality. To this end, the Informatics Core Director will support investigators in the custom design of databases for their studies, ensure that laboratory and other research data are transferred from the Core Lab and other sources, such as the Hospital's Oacis, into those databases, and help investigators in other aspects of scientific and technical computing. For example, Kevin Le, the Informatics Core Director, works closely with the Center's Biostatistician, Dr. Theodore Karrison, to assure that data collection and storage are optimal for eventual computerized statistical analysis. The Informatics Core Director can also advise investigators when they choose computers and software for their studies, help explore and evaluate new computer technologies with respect to medical applications, and help investigators solve computational and informational problems. Click the following link to learn more about  data collection and recording guideline