The following information will explain to you the purpose of the GCRC, the numerous resources available to you, the application process including the mandatory format for your research protocol, and how to get started.

For advice on protocol format and/or the submission process contact Julie Traylor.

Submit application documents to:

Julie Traylor
GCRC Administrative Director
O'Donoghue Research Building, Ste. 150
405-271-4272 Ext. 42709
Julie-traylor@ouhsc.edu

The following staff may also be contacted at 271-4272 if you need further assistance:

Julie Traylor, RN, BSN
 Administrative Director  x42709  julie-traylor@ouhsc.edu 
Timothy Lyons, MD Program Director  1-4272   timothy-lyons@ouhsc.edu 
John Mulvihill, MD Assoc. Program Director  1-4272  john-mulvihill@ouhsc.edu 
R. Hal Scofield , MD   Research Safety Advisor  x42710  hal-scofield@ouhsc.edu 
Chris Aston, PhD   Biostatistics/Informatics Director  x42714  chris-aston@ouhsc.edu 
Misti Leyva, MS, RD/LD  Bionutrition Director  x42731  misti-leyva@ouhsc.edu 
Lancer Stephens, MS Special Populations Unit Director x42732 lancer-stephens@ouhsc.edu 
Andrew Gardner, PhD  Exercise Physiology Director x42743  andrew-gardner@ouhsc.edu 


OUHSC General Clinical Center



Purpose:
The General Clinical Research Center (GCRC) is an institutional resource funded by the National Institutes of Health (National Center for Research Resources) to support clinical research at the University of Oklahoma Health Sciences Center. The General Clinical Research Center Program provides a clinical research infrastructure for medical researchers who conduct patient-oriented research. The GCRC can be used by investigators who are supported by the National Institutes of Health (NIH) and investigators who are supported by funds provided by other federal, state and local agencies. The GCRC is an appropriate site for pilot studies that may lead to future NIH support, but is not intended to be the sole source of research support for extended studies. The investigations carried out in the GCRC can include studies of normal and abnormal human physiology and studies of the cause, prevention, progression, control, and cure of diseases that afflict individuals of all ages and ethnic backgrounds. Collaboration between basic and clinical scientists is encouraged.  Resources are provided to translate basic scientific discoveries into new diagnostic and therapeutic methods that improve the health care of all U.S. citizens.

Resources:
The GCRC is located in a newly remodeled 13,000 square foot area on the 1st floor of the O'Donoghue Research Building, 1122 N.E. 13th Street (ORI-150). The resources of the GCRC are available to all services and departments. GCRC resources include the following:
  1. Seven multi-purpose outpatient testing rooms
    1. 12 lead EKG
    2. Spirometer
    3. Vital sign monitoring equipment
    4. Pulse oximetry
    5. Stadiometer
    6. Fully equipped crash cart
    7. Treadmills
    8. Infusion chairs
    9. Physician available for physical exams

  2. Neurophysiology procedure room
  3. DEXA(Dual Energy X-ray Absorptiometry)
  4. Metabolic Kitchen
    1. Regular meals
    2. Nutrient-controlled diets
    3. Weighed diets (Mettler electronic balances)
    4. Therapeutic diets (ADA, renal, etc.)
    5. Snacks for fasting subjects
    6. Take home meals

  5. Limited support available to provide in-patient beds for research studies
    1. GCRC nurses will be available to collect data on these patients in the hospital

  6. Nursing staff trained in implementing research protocols
    1. Patient assessments
    2. Timed specimen collection
    3. Questionnaire administration
    4. Patient education
    5. Medication administration
    6. Individualized nursing care for intensive protocol needs
    7. Routine and complex vital sign monitoring
    8. Assistance with subject compliance monitoring
    9. In-depth individual and family medical history interviews
  7. Nutrition staff trained in clinical research
    1. Preparation of research diets
    2. Diet histories
    3. Nutrition assessments
    4. Anthropometrics
    5. Patient education
    6. Computer analysis of intake
    7. Design of nutrition component protocols
    8. Bioelectrical Impedance Analysis (BIA)
    9. Indirect Calorimetry (Med Graphics Metabolic Cart)

  8. Biostatistical assistance
    1. Study design
    2. Sample size estimates
    3. Planning for data analysis
    4. Assistance with data display and analysis for interim and final reporting
    5. Assistance with data display for publications and presentations

  9. Computer assistance
    1. Data storage
    2. Database management consultation
    3. Forms design

  10. Sample processing laboratory
    1. Refrigerated/non-refrigerated centrifuge
    2. -80 degree Freezer with limited short-term storage
    3. Processing of samples for transport to investigator's labs
    4. Barcoding system for patient anonymity
    5. Collection of samples

  11. Limited support is available to provide routine laboratory tests

  12. Research Subject Advocate services
    1. Assist GCRC investigators in establishing appropriate data and safety monitoring plans
    2. Ensure that investigators follow their IRB-approved protocols
    3. Ensure that serious adverse events are reported to the IRB in a timely manner
    4. Provide education for principal investigators, study coordinators and GCRC staff

  13. Special Populations Unit
    1. Serves as a culturally sensitive liaison between GCRC investigators and minority communities.
    2. Catalyze the research involvement of members of minority communities in the area of OUHSC.
    3. Address in a proactive fashion the collective concerns of special populations about participating in research projects of the GCRC investigators.
    4. Serve as a culturally sensitive liaison between these minority communities.

Application Process:
  • Application
    Protocol application forms are available from the GCRC administrative offices and on-line at the GCRC web page (gcrc.ouhsc.edu). Contact the GCRC Administrative Director, Julie Traylor, (271-4272, Ext. 42709) to initiate the application process and for assistance with questions regarding budget development. It is critical that investigators work with the staff of the GCRC as early as possible in the development of the protocol to ensure that their study optimally and appropriately utilizes the resources of the GCRC.

  • Eligibility for GCRC Utilization
    The GCRC is available to researchers (M.D., Ph.D., and others) and trainees who wish to conduct patient-oriented research.  Each project conducted at the center must include at least one faculty physician who assumes overall patient responsibility. No study may be implemented on the GCRC without prior approval of the OUHSC Institutional Review Board and the GCRC Advisory Committee (scientific review).

  • Completing & Submitting the Application
    The GCRC is committed to a user-friendly application procedure that keeps the paperwork burden for investigators to a minimum. NIH requires the information requested on the application. Feel free to contact the GCRC Administrative Director or Program Director for assistance.

    The following items are required as part of the GCRC application. Omission of any of the following items will delay your GCRC Application. Submit your application to the GCRC Administrative Director, Julie Traylor, at P.O. Box 26901, ORI-150, Oklahoma City, Oklahoma 73190 or email the application to julie-traylor@ouhsc.edu. The application must be submitted by the 10th of the month to be placed on the next month's agenda.

    1. GCRC Application
    2. GCRC protocol in electronic form (see below for required format)
    3. If funded, you must attach a copy of your most recent summary statement or scientific review of your project, award letter and approved budget with budget justification.
    4. If funding is pending, you must include budget pages and budget justification.
    5. Copy of IRB application.
    6. Copy of any questionnaires to be administered to subjects.
    7. Abstract of the project.
    8. A two or three line description of the study in easy to understand language. This information will be posted on our website for any potential participant to view.
    9. Proof of Human Subject Protection Training for all Investigators and Study Coordinators.

Mandatory Format for Research Protocol
Please outline your research proposal using the following format, which is a modification of PHS-398. GCRC staff will review your proposal prior to presentation to the GCRC Advisory Committee (GAC). The GAC meets the 1st Monday of each month. GAC review of the proposal is required by NIH before any GCRC support can be provided. Consequently, although the goal of the GCRC is to promote clinical research, we need you to provide information needed for the review in a timely way; otherwise, delays in review or resource allocation will result. Please make sure to include the date and version number of the protocol on the bottom of each page. If your protocol does not follow the following format, it will be returned to you for reformatting.

GENERAL CLINICAL RESEARCH CENTER
Research Protocol

GCRC #_______                        
Title:

Principal Investigator:   Name; Degree; Department
(Example: Don Brown, M.D., Dept of Medicine)

 
Co-Investigators:   Name; Degree; Department
(Example: Sally Smith, Ph.D., Dept of Biostatistics)
 

Abstract
Include all the essential elements of the protocol - no more than 250 words. 

Note: The Research Plan, A through E, should not exceed 1,500 (approx 5 pages) word limit.
Protocols should be single-spaced, have 1" margins, and contain characters of no less than size 12 font.
                                                                                                   
  1. Specific Aims
    State the hypothesis and specific aims. List the long-term objectives and what the proposed research will accomplish. (suggested length: a paragraph or two)

  2. Background and Significance
    Sketch the background leading to this study, evaluate existing knowledge, and identify gaps, which this study will fill.  State the importance of the research by relating the specific aims to the long-term objectives. (suggested length: ½ page)

  3. Preliminary Studies/Progress Report
    Provide an account of previous studies and/or information that establishes the experience and competence of the investigator to pursue the protocol. (suggested length less than ½ page)

  4. Research Design and Methods
    Describe the research design and procedures to be used (what, when, how) on the GCRC.  Provide a flow diagram or timetable.  Procedures, situations, or materials that may be hazardous to personnel and the precautions, should be outlined here. (suggested length at least 2 pages)

  5. Statistical Methods (for statistical advise contact Christopher Aston, PhD at 271-4272 ext 42714 or chris-aston@ouhsc.edu)
    Provide biostatistical design, power calculations determining the number of subjects, and the proposed analysis. (suggested length: ½ page)

  6. Gender/Minority/Pediatric Inclusion for Research
    NIH requires all GCRC protocols must include documentation of the inclusion of women and minorities in the research protocol.

    Date 
    		 __________________ 
    Version 
    		 __________________ 

  7. Human Subjects
    1. Provide number, age range, and health status of the subject population. Identify criteria for inclusion or exclusion. IF ONE GENDER AND/OR MINORITIES ARE NOT INCLUDED, INCLUDING CHILDREN (Age up to 21 yrs.), PROVIDE A CLEAR RATIONALE FOR THEIR EXCLUSION.
    2. Identify sources of research material in the form of specimens, records or data.
    3. Describe plans for recruitment and consent procedures to be followed.
    4. Describe risks and assess likelihood and seriousness.
    5. Describe procedures for protecting against or minimizing potential risks.
    6. Describe potential benefits and importance to the subjects and others.
    7. Discuss why risks are reasonable in relation to benefits.

  8. Data and Safety Monitoring Plan (for advise on DSMP contact R. Hal Scofield at 271-4272 ext. 42710 or hal-scofield@ouhsc.edu)
      NIH requires that all GCRC protocols must have a Data and Safety Monitoring Plan
    1. Describe the Data and Safety Monitoring Plan (DSMP)
      1. reporting mechanisms for adverse events to the IRB, FDA, NIH.
      2. adverse event (AE) grading
      3. plan for unanticipated AE reporting
      4. plan for annual reporting of AEs
      5. interim efficacy analysis where appropriate
    2. Describe the Data and Safety Monitoring Board (DSMB) that will be responsible for monitoring the study.
      • Institutional studies provide:
        1. Chair, members       
        2. frequency of safety reviews
      • Phase III, NIH Studies, or Co-Operative Studies (eg ECOG; ACTG), or Drug Sponsored (D) Studies provide:    
        1. contact name
        2. brief description of Sponsor's plan


    Data and Safety Monitoring Plan Template

    1. Adverse event (AE) reporting:
      Adverse events anticipated in this [insert level of risk] risk study that involves [insert a synopsis of testing and interventions] include [describe adverse events]. In the event that an adverse event occurs, [describe your plan to report adverse events such as the following] research staff will report such to the Investigator who will then advise the IRB, the GCRC Research Participant Safety Advisor (Safety Advisor), and the NIH and/or sponsor as indicated [you need to identify your sponsor or others who you will report adverse events to]. In absence of moderate or serious adverse events, as is appropriate with [identify your study's risk level] risk studies, reports of study progress will be submitted to the GCRC Advisory Committee (via the Safety Advisor) and the IRB for review on an annual basis [or more often if the GAC, Safety Advisor, or IRB require more frequent reports or reviews].


    2. Risk minimization:
      All study procedures will be performed according to protocol and IRB-approved recruitment/consent procedures and the enrollment inclusion/exclusion criteria previously listed will be closely adhered to. Possible risks associated with participating in this study include [list physical, emotional, socioeconomic, insurability, or stigmatizing risks in detail just like in your IRB application; you might be able to copy this from Section E of a PHS398 application or your IRB application].

      Risks associated with [name the test or procedure and then describe all; just like in your PHS 398 or IRB application]. These risks will be minimized by [list procedures to minimize risk and you may include the following as well], by allowing only well-trained clinical research staff to perform study procedures and testing according to standard practice, and by making sure study participants clearly understand study procedures before and during the study protocol.

      Side effects known to occur with [list tests and treatments involved in the study] include [list the side effects of each]. The possibility of these occurring will be minimized by [tell how you will do this].


    3. Study termination:
      Criteria for early withdrawal of individuals from this study are: [list reasons and you may wish to add the following] and/or a participant's inability/unwillingness to adhere to study protocol. Criteria for early termination of the study include [list why you would stop the study completely: high proportion of serious side effect (list), early significant effect in a specific arm of the study, etc.]


    4. Confidentiality:
      [Include what you wrote in your PHS398 or IRB application and you may add the following.] Study participants will be assigned study numbers and specimen samples will be tagged with these numbers before laboratory analyses are performed. We will not use any identifying information in data analysis procedures or in research reports.


    5. Data integrity and security:
      [Describe how you will protect your data and assure data integrity (random quality checks, etc.) and/or you may include the following.] We will ensure data integrity and security under the direction of the GCRC Informatics Director's Advice. Hard copies of clinical information and data will always be kept in a secured place on the GCRC or in our research office, and only study team members will be able to access them. Electronically formatted data will adhere to security standards set by the Informatics Director, the IRB, and the OUHSC [you can describe these].


  9. GCRC Needs and Requirements
      Indicate what GCRC resources are necessary.
    1. Category (A, B, D) and Total Number of patients:
    2. Total Number of outpatient visits or inpatient bed days:
    3. Length of study from start to finish:
    4. GCRC Nursing requirements:YN
    5. GCRC Core lab requirements. Processing: YN Assays: YN
    6. GCRC Metabolic Kitchen/Nutritional requirements: YN
    7. Informatics (Computer system data support): always Y
    8. GCRC Biostatistical Support:always Y
    9. Ancillary Costs:
    10. Non-GCRC Financial support for the study: agency, ID number, project period, total Direct Costs
      (Example: Lilly, LY123456, 09/01/98 - 08/31/2000, $350,000)


  10. Literature Cited
    List only literature cited within the text.  Use NIH format: names of all authors, title, book or journal, vol, page, year. (suggested length:no more than 12 references)
Date



Version Review Process
All protocols submitted to the GCRC are first reviewed, discussed, and evaluated by the GCRC Staff. The feasibility of carrying out the protocol is evaluated by all members of the staff as is relevant to their responsibility and involvement in the particular protocol. In addition to laboratory, data management, data analysis, nutrition, and nursing needs, the budgetary requirements are carefully scrutinized to determine if the GCRC can provide the service within the framework of institutional and NIH policies and availability of funds.

Once approved by the GCRC staff, the protocol is presented to the GCRC Advisory Committee (GAC). The GAC is made up of members of the faculty who are familiar with GCRC research activities and who represent a cross-section of the medical school. The GAC meets monthly, on the 1st Monday of the month to discuss current issues, set policy, and review protocols submitted for use of the GCRC resources. These reviewers may contact you with questions while completing their review.

Please note that the approval of a protocol and its budget is not a grant and should not be listed as such on your other support for NIH or other applications.

Proceeding With Your Protocol
GCRC Staff In-Service Meeting

Prior to initiating the protocol, the investigator must familiarize the GCRC staff with the goals and mechanics of the study. At the in-service discussions focus on the detailed design and implementation of the research protocol. The GCRC is responsible for coordinating and conducting in-service presentations. Before a protocol can be initiated at the GCRC, the investigator must schedule an in-service with the GCRC Administrative Director. To schedule a meeting, the investigator should call the GCRC Administrative Director, at 271-4272 extension 42709 or email at Julie-Traylor@ouhsc.edu.

Approved Consent Form
No protocol can begin until all approved IRB consents and IRB approval letter are on file in the GCRC as required by NIH.Please forward these materials to Tamara Filer as soon as received.

All active GCRC protocols must receive annual re-approval by the IRB.A copy of the renewal letter and updated consent form must be sent by the investigator to the GCRC Administrative Director.

All IRB correspondence and approved amendments to protocols should be forwarded to the Administrative Director.

No subject will be seen at the GCRC unless we have a copy of their signed consent form. The IRB requires that each patient have adequate time to read the consent form, ask any questions, and to sign the consent form. The subject must also be given a copy of the consent form.

GCRC/NIH Information
Publication credit: In order to secure continuing funding of the General Clinical Research Center Program and our GCRC, it is necessary to apprise reviewing bodies of our research accomplishments. Accordingly, it is essential that all manuscripts submitted for publication contain the acknowledgment.

"This work supported in part by the University of Oklahoma Health Sciences Center General Clinical Research Center grant M01-RR 14467, National Center for Research Resources, National Institutes of Health."

Reprints:Upon publication of a manuscript, two reprints should be forwarded to the GCRC Administrative Director to be kept in the Center Bibliography file for examine by site visitors AND to provide feedback to the staff on work in which they participated.

GCRC Annual Report: The GCRC Annual Report to the General Clinical Research Center Program is prepared in April. At that time you will be asked for:
  1. An abstract for each active protocol, briefly discussing the purpose of the project.
  2. A list of publications derived from work using the GCRC resources.
  3. Current grant support information.
  4. Proof of completion of NIH required Human Subject Protection Education.

GCRC Continuation Budget: The GCRC continuation budget is prepared in December. At this time you will be asked for an estimate of ancillary expenses projected for the following March-February grant year.
Revised 8-31-05
 
The University of Oklahoma Health Sciences Center
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General Clinical Research Center
 O'Donoghue Research Building Suite 150
1122 N.E. 13th St. 
 Oklahoma City, Oklahoma 73104
Phone: (405)271-4272
E-mail: julie-traylor@ouhsc.edu

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