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                                                                               GCRC Protocol #
                                                                               Approval Date:



General Clinical Research Center
Application to use the GCRC resources
The GCRC Scientific Advisory Committee (SAC) will review this application for scientific merit and
resource utilization. To complete this form, refer to the GCRC Application Instructions.

IRB Status: Date Approved:            IRB Protocol #            Approval Pending
IRB project title:

                                      GENERAL INFORMATION


 Project Title:

 Principal Investigator:
 Last Name               First Name        Academic Title        Department

 Mailing Address & M/C                     Campus Phone          Fax Number        E-mail Address


 Co-Investigators (for UIC GCRC project):
 Last Name               First Name        Title                 Department

 Mailing Address & M/C                     Campus Phone          Fax Number        E-mail Address

 Last Name               First Name        Title                 Department

 Mailing Address & M/C                     Campus Phone          Fax Number        E-mail Address

 Last Name               First Name        Title                 Department

 Mailing Address & M/C                     Campus Phone          Fax Number        E-mail Address

 Last Name               First Name        Title                 Department

 Mailing Address & M/C                     Campus Phone          Fax Number        E-mail Address

 Last Name               First Name        Title                 Department

 Mailing Address & M/C                     Campus Phone          Fax Number        E-mail Address

 Last Name               First Name        Title                 Department

 Mailing Address & M/C                     Campus Phone          Fax Number        E-mail Address

 Last Name               First Name        Title                 Department

 Mailing Address & M/C                     Campus Phone          Fax Number        E-mail Address

 Last Name               First Name        Title                 Department

 Mailing Address & M/C                     Campus Phone          Fax Number        E-mail Address




                                                   1                                        12/01
 Study Coordinator(s):
 Last Name                  First Name         Title               Department

 Mailing Address & M/C                         Campus Phone        Fax Number       E-mail Address

 Last Name                  First Name         Title               Department

 Mailing Address & M/C                         Campus Phone        Fax Number       E-mail Address

 Last Name                  First Name         Title               Department

 Mailing Address & M/C                         Campus Phone        Fax Number       E-mail Address



A physician with appropriate expertise and UICH admitting privileges must be
substantively involved in each GCRC protocol and should be the investigator or co-
investigator. See GCRC application instructions “Physician coverage” section for role of
study physician. The physician responsible for medical coverage for this study:
             Principal Investigator
             Co-Investigator (name):


                                         PROJECT INFORMATION

Type of study:
          Inpatient              Outpatient   Both

Is this a pilot study (see Application Instructions for definition of “Pilot Study”)?
           No
          Yes

Is this study a Clinical Trial (see Application Instructions for definition of “Clinical Trial”)?
           No
           Yes (indicate phase of study as defined in the Application Instructions):
                         Phase   I
                         Phase   II
                         Phase   III
                         Phase   IV

In addition to participation in the research study, will billable clinical care occur in the
GCRC?
             No
             Yes (below, please provide a description of the billable clinical care):




                                                       2                                     12/01
List all research medications and any adjunctive medications, food additives or dietary
supplements* to be used in this protocol. The cost of these substances is the
responsibility of the Investigator.

                                                                                                    IND Status
                                                                                                     Enter date
   Name of Substance                             Dosage            Route**                 Submitted or Approved or N/A




       * See Application Instructions for description. ** Route: P.O., I. V., Sub-Q, I. M., Topical, Ophthalmic, or intradermal



Provide information on specialized equipment or investigational devices to be used in the
GCRC.

                                       Stored in                                                          IDE Status:
  Equipment/Device                      GCRC?                 Operated by:                                 Enter date
                                        Yes No           Study Staff or GCRC Staff                Submitted or Approved or N/A




       Study staff: Principal investigator, Co-investigator and study personnel. GCRC Staff: Nursing staff, laboratory technician, and
       bionutrition staff.



List all specialized clinical procedures (e.g., skin, liver, muscle, or bone marrow biopsy) to
be performed in the GCRC.

                                                                                             Procedure performed by:
   Clinical Procedure(s):
                                                                                              Study Staff or GCRC Staff




       Study staff: Principal investigator, Co-investigator and study personnel. GCRC Staff: Nursing staff, laboratory technician, and
       bionutrition staff.




                                                              3                                                          12/01
Clinical sites of study (check all that apply):
            General Clinical Research Center
            Psychiatry Clinical Research Center
            Other sites (list below all at UIC and at other institutions):




What is the planned total length of the study in the GCRC?
         Duration:                    Anticipated Start Date:

Origin of the study design and protocol:
           Written by P.I.
           Written by Industry sponsor (refer to the Application Instructions)
           Other (describe):

Protocol Funding: Indicate in the table what funding sources support this protocol.
                                    #1                        #2                 #3
  Funding Source:
  P.I. of grant:
  Project Number:
  Inclusive Dates:
  Active or Pending ?:
  Current Year Direct
  Costs
*See Application Instructions

Grant Title #1:
Grant Title #2:
Grant Title #3:




                                                4                                     12/01
                                PROJECT DESCRIPTION
In a separate document, describe the protocol using the following format. Limit
the abstract to 100 lines and the description (sections 2-5) to five, single-spaced pages.
There is no limit for sections 6,7,9. The references should be no more than two pages.
(additional information is located in the application Instructions).

   1. Abstract (in non-technical terms)
   2. Hypotheses/Specific aims
   3. Background/Significance
   4. Preliminary studies
   5. Research Design and Methods
          a. Study design
          b. Laboratory & other procedures
          c. Statistical considerations
   6. Human subjects considerations: Describe human subject information in the format
      listed below.
          a. Population description
          b. Source of research material
          c. Recruitment of subjects
          d. Potential risks/alternative treatments
          e. Procedures for minimizing risks
          f. Risks in relation to benefits
          g. Data and Safety Monitoring:
                i. NIH requires every GCRC application to include a Data and Safety Monitoring
                Plan (DSMP). Please go to the GCRC home page and click on “Application” to
                download a DSMP form and instructions.
   7. Proposed schedule for study visits to the GCRC
   8. References
   9. Subject selection (Gender/Race/Ethnicity/Children): Use the NIH format, which
      requires the following four sections:
          a. Inclusion of women;
          b. Inclusion of minorities;
          c. Inclusion of children; and
          d. Composition of study population (Targeted Enrollment, Table I, and
             Enrollment to Date, Table II), with the rationale for selection of subjects in
             terms of the scientific objectives and the proposed study design.




                                           5                                         12/01
                                                                                                        Formatted: Bullets and Numbering
   i.I.    (Required) Expected distribution for this study. (Do not use percentages)
                                                               Sex/Gender
   Ethnic Category
                                                 Females (n)     Males (n)   Total (n)
   Hispanic or Latino
   Not Hispanic or Latino
   Ethnic Category Total All Subjects
   Racial Categories
   American Indian/Alaska Native
   Asian
   Native Hawaiian or Other Pacific Islander
   Black or African American
   White
   Racial Categories: Total of All Subjects*
   *The “Ethnic Category Total of All Subjects” must be equal to the “Racial Categories Total
   of All Subjects.”

   II.     ii. Number of subjects recruited to date, if applicable.

                                                                Sex/Gender
                                                Females    Males     Unknown or             Total (n)
Ethnic Category
                                                  (n)       (n)     Not Reported
                                                                         (n)
Hispanic or Latino
Not Hispanic or Latino
Unknown (not reported)
Ethnic Category Total All Subjects
Racial Categories
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More Than One Race
Unknown or not reported
Racial Categories: Total of All Subjects*
   Part B. Hispanic Enrollment Report: Number of Hispanics or Latinos Enrolled to Date
                                      (cumulative)

          Racial Categories
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More Than One Race
Unknown or not reported
Racial Categories:
Total of Hispanics or Latinos**

                                            6                                       12/01
      *These totals must agree. **These totals must agree

                               REQUEST FOR GCRC RESOURCES

Please fill in the table below for the first 12 months (Be sure to review GCRC application
instructions “Physician coverage” section for role of study physician):

                       PATIENT CARE                   Per 12 Months
               # of inpatient subjects
               # of inpatient days/subject
               Total # of inpatient days/yr.

               # of outpatient subjects
               # of outpatient visits/subject
               Total # of outpatient visits/yr.



                            Request for NURSING Services
        Contact Jane Strong, MSN, RN at 6-7435 or jstrong@uic.edu for assistance.
Please indicate the services you are requesting from the GCRC Nursing Staff
(check all that apply).

      Routine nursing care
      Vital signs
      Arteriopuncture
      Venipuncture (phlebotomy)
      IV catheter insertion
      Blood draw via IV catheter
      Collection of urine/other biological specimens
      Sample processing from 4:00 PM – 7:00 AM
      Medication compliance assessment
      Assistance with tissue biopsies
      Administration of questionnaires/surveys
      Central line/venous access device care
      Other:

Will your grant cover cost for any medical/nursing supplies?

      No
      Yes (please list below supplies your grant will provide):



Are any nursing services needed off-site (i.e. away from the GCRC unit)?

          No             Yes                What Services      Where




                                                  7                                12/01
               Request for INVESTIGATIONAL PHARMACY Services
        Contact Julie Huang, Pharm D at 6-4541 or jhuang@uic.edu for assistance.
It is required that an investigational pharmacist dispenses all pharmacy-related
substances. Please indicate the services you are requesting from the
investigational pharmacist (check all that apply).

        Dispense non-investigational drug(s)
            List:
        Dispense non-investigational dietary supplement(s)
            List:
        Dispense investigational drug(s)
            List:
        Dispense investigational dietary supplement(s)
            List:
        Develop randomization tables
        Provide blinded substance distribution
        Procure study medication(s)
        Provide other research-related medications (i.e. prn, supportive care)
        Prepare IV medications
        Maintain drug accountability
        Special compounding (i.e. medications)
        Assess medication compliance
        Provide patient medication education
        Other:




                                         8                                       12/01
                           Request for LABORATORY Services
               Contact Hossein Sagha, at 3-0810 or hms@uic.edu for assistance.
Please indicate the services you are requesting from the GCRC Laboratories
(check all that apply).

      Assistance with the laboratory component of experimental design
      Shipping only
      Flash freezing of specimens (in liquid nitrogen)
      Sample processing/Investigator to pick up samples
      Sample processing/send samples to UICH laboratory
      Sample processing/send to outside laboratory:
              List name of laboratory(s) below:




The following is a list of assays that the GCRC currently performs. Check those that apply
and indicate the total number of assays required for each subject:

                        Total # Per Subject
Assays currently available:

      Insulin
      Glucose
      Osmolality
      Hemoglobin

Do you plan to use the radioisotope laboratory facilities?

      No
      Yes (refer to the Application Instructions)

Are any lab services needed off-site (i.e. away from the GCRC unit)?

      No                  Yes          What Services       Where




                                             9                                    12/01
                     Request for BIONUTRITION Services
     Contact Cindy Carey, MS, RD, LD at 6-4511 or carey@uic.edu for assistance.
Please indicate the services you are requesting from the GCRC Dietitian (check
all that apply).

      Provide general diet meals
      Provide general diet snacks
      Provide research diet meals
      Provide research diet snacks
      Controlled feeding diet
      Calculated diet (rotating menus)
      24-hour diet recalls
      Food Frequency Questionnaire
      Multiple food records
      Nutritional analysis of diet assessment
      Instructions for keeping food records
      Intervention counseling or diet instruction
      Administration of health questionnaires
      Body composition
      Indirect calorimetry
      Other:



   Are any Bionutrition services needed off-site (i.e. away from the GCRC unit)? Research
   and/or general meals or snacks that need to be packaged for consumption off the
   GCRC unit should also be requested below.

       No                 Yes         What Services      Where




                         Request for BIOSTATISTICS Services
            Contact Marlos Viana, PhD at 6-8384 or viana@uic.edu for assistance.
Please indicate the services you are requesting from the GCRC Biostatistician
(check all that apply).

      Study design
      Quantification and measurement issues
      Mathematical Modeling
      Simulation Studies
      Assistance with interim data analysis
      Assistance with final data analysis




                                          10                                    12/01
                            Request for INFORMATICS Services
                 Contact Kevin Le, BSCS at 3-3254 or lle5@uic.edu for assistance.
Please indicate the services you are requesting from the GCRC Informatics
Manager (check all that apply).

      Design, setup new database
      Modify existing database(s)
      Develop user-friendly application to collect data, make queries, and generate
   various crystal reports
      Custom design reports and other outputs from existing database(s)
      Advise on acquisition and use of computer hardware/software
      Transfer, import, and export data among different computer software programs
      Provide special-purpose programming
      Train user on writing query statements using Microsoft Access, SQL 2000 to make
   use of data
      Optimize data collection and quality control
      Provide database storage and backup
   Other:




                         Request for FINANCIAL Arrangements
         Contact Irene Ziaya, LCSW, MM at 6-6248 or iziaya1@uic.edu for assistance.
In limited instances, the GCRC may be able to cost-share specific tests or procedures in
your study. If you are requesting ANY financial assistance from the GCRC, please BE
SPECIFIC and include in the provided space, justification for this request.

     Name of test/procedure/item                        Cost/Test     Number/subject




Justification:




                                             11                                     12/01

								
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