Adult General Clinical Research Center
University of Colorado Health Sciences Center
National Jewish Center Satellite
University of Colorado Boulder Satellite
Protocol Application
Date Submitted:
Title:
Protocol Number
(This will be assigned by the
GCRC at the initial review)
Name Academic Rank Department / Division Phone
Number
Campus
Box
Principal Investigator:
Co-Investigators:
Contact Person:
I agree to provide all information requested by the GCRC in a timely manner. Information will be requested on a yearly basis to satisfy NIH reporting requirements.
Signature of Principal Investigator
(my typed name indicates agreement with the above statement)
_____________________________________________________________________________
Human Subjects (COMIRB) Status : pending approved # Date approved
Type of Study : Category A Study - Visits will be for research purposes ONLY - Investigator-Initiated
Category B Study - Visits will be for Research Service Patients
Category D Study - Visits will be for an Industry-Initiated study - All 'D' studies must provide the industry-approved budget and three copies of the industry protocol with this application
Research Area :
Select Here Other (if not in list):
General Utilization Information
Is this study: Inpatient Outpatient Both Inpatient & Outpatient
How many subjects do you plan to enroll at the GCRC?
If this is a multi-center trial, how many total subjects will be enrolled?
What will be the estimated duration of the study, in years?

Important note : If cutting and pasting from other documents, remove all page breaks or section breaks from originals first.
Breaks pasted in from originals prevent you from editing this form afterward. (questions, call Tom Yaeger 372-8803)
Title:
I.
Hypothesis and Specific Aims
Hypothesis:
2
Specific Aims:
II.
Background and Significance
III.
Progress Report / Preliminary Studies
IV.
Research Design and Methods
Sample Size Justification and Analysis Plan
V.
Human Subjects
Description of Study Population
Sources of Research Material
Subject Recruitment and Consent Procedures
Potential Risks and Alternative Treatments
Procedures for Minimizing Risks
Risk/Benefit Analysis
VI.
Gender and Ethnicity Tables
Table 1 National Demographics for the Study Population (in percentages)
American Indian or Alaskan
Native
Female
Male
Unknown
Total
Source:
Asian or
Pacific
Islander
Black, not of
Hispanic Origin
Hispanic White, not of
Hispanic Origin
Other or
Unknown
Total
100%

Table 2 Local Demographics for the Study Population (in percentages)
Female
Male
Unknown
Total
Source:
American
Indian or
Alaskan Native
Asian or
Pacific
Islander
Black, not of
Hispanic Origin
Hispanic White, not of
Hispanic Origin
Other or
Unknown
Total
100%
Table 3 Expected Distribution for this Study ( in numbers of subjects)
Female
Male
Unknown
Total
American
Indian or
Alaskan Native
Asian or
Pacific
Islander
Black, not of
Hispanic Origin
Hispanic White, not of
Hispanic Origin
Other or
Unknown
Total
VII.
Justification for Utilization of GCRC Resources
3
VIII.
Bibliography
Important note: Remove all page breaks or section breaks from original before pasting. Breaks pasted in from original prevent you from editing form afterward. (questions; call Tom Yaeger 372-8803)
Consent Form see important notice above (Insert here.)
One Year Projected Utilization of the GCRC
How many subjects do you plan on enrolling in Year 1 of your study?
A.
SCREENING VISITS
1.
Total number of subjects you will screen per year
2.
Number of screening visits per patient
3.
Approximate length of screening visits (hours)
B.
OUTPATIENT CLINIC VISITS
C.
1.
Total number of subjects to be seen per year
2.
Total number of outpatient visits per subject ( do not include screening visits)
3.
Length of outpatient clinic visits
SHORT STAYS ON THE INPATIENT UNIT (The subjects will not stay over night)
**These stays will be counted as outpatient visits .
1.
Indicate the total number of subjects to be seen per year
2.
Total number of inpatient admissions per subject
3.
Length of stay
4.
Research nursing services requested (please check)
Phlebotomy Yes No

D.
RMR
Exercise Testing
IVGTT
Euglycemic Clamp
Other
Yes
Yes
Yes
Yes
No
No
No
No
If yes, # per patient
If yes, # per patient
INPATIENT ADMISSIONS (The subjects will have an overnight stay)
4
1.
Indicate the number of subjects to be admitted per year
2.
Total number of inpatient admissions per subject
3.
Length of each inpatient stay (please check)
1 day 2 days 3 days 4 days 5 days other
4.
Research nursing services requested (please check)
Yes No Phlebotomy
RMR
Exercise Testing
IVGTT
Euglycemic Clamp
Yes
Yes
Yes
Yes
No
No
No
No
If yes, # per patient
If yes, # per patient
Other
E.
DIETARY SERVICES
– (Available at the University of Colorado Health Sciences Center)
If you are requesting any dietary support including inpatient/outpatient meals, please complete the following.
1.
Meals Requested : Inpatient Outpatient
Will any meals be packed out?
Calorimetry Room, # of days:
Yes No
Are meals to be served at specific times?
2.
Other Services
Yes No
Please check any other services requested:
Diet History :
24 Hr Recall
Research Diet Instruction :
Test Meals :
Patient
3-day Food Record
Family/Spouse
Food Frequency
Check here if provided by GCRC Specify meal:
3.
Special Diets/Requests :
F.
ANCILLARY REQUESTS – YEAR ONE
List only those ancillary costs that you are requesting to be paid by the GCRC. Distribution of ancillary funds is at the discretion of the Scientific Advisory Committee.
1.
Request for Laboratory Tests Please list the total number of tests to be run in Year 1 on an inpatient and outpatient basis. List tests separately. (While working in the table depress the tab key from within the last cell to add new row)
Laboratory Name Test Name Total # tests per year
Inpatient Outpatient &
Short Stays on I/P Unit
2.
Request for Sample Processing (i.e. Processing for laboratories other than the GCRC Core Lab)
UCHSC For the Drug Company
Indicate the # of samples per patient

5
Are you requesting long term storage (> 2 months)? Yes No
3.
Other Ancillary Requests: Please list any other ancillary support you are requesting (i.e.,EKG’s, xrays).
(While working in the table depress the tab key from within the last cell to add new row)
Ancillary Department Service Requested Total # per year
Inpatient Outpatient &
Short Stays on I/P Unit
G.
INFORMATICS & COMPUTER SUPPORT
(some services only available at the University of Colorado
Health Sciences Center)
Please check the following Informatics services that you are requesting (all are free of charge for category 'A' studies):
Data management - this includes assistance with data quality and preparing data for analysis
Data storage on the GCRC Server/ Computer system - offers daily backup and data security
Custom database designed for the input and analysis of all data collected in your study
Use of GCRC Computer Equipment
Computer & Laser printer on the unit CD ROM for archiving data Scanner
Statistical software - installation, licensing, and support of SAS and/or JMP (if you already have a license for either program through the GCRC and plan to use it for this study, please check this box)
Results from our Core Laboratory electronically downloaded to you for access from your office PC
H.
BIOSTATISTICAL SUPPORT
Did you consult the GCRC Biostatistician during the design of your research protocol?
If it were available, would you request assistance with the analysis of your study data?
I.
BRIEF SUMMARY (in layperson’s language)
Yes No
Yes No
J.
AXIS CODES
Check off at least one Axis Code for each of the three sections. You may select up to six codes for each Axis.
Axis I: Resource Material
2
3
4
5a
5b
5c
5d
6
7a
1a
1b
1c
1d
1e
1f
Animals (Whole): Vertebrates, Mammal
Animals (Whole): Vertebrates, Non-Mammal
Animals (Whole): Invertebrates
Animals (Cell-Org): Vertebrates, Mammal
Animals (Cell-Org): Vertebrates, Non-Mammal
Animals (Cell-Org): Invertebrates
Biological/Chemical Compounds
Biomaterials
Human, Cells Only
Human, Adult, Female
Human, Adult, Male
Human, Infant/Child, Female
Human, Infant/Child, Male
Membrane/Tissue/Isolated Organ
Microorganisms – Bacteria
7b
7c
7d
8
Microorganisms – Virus
Microorganisms – Parasites
Microorganisms – Other
Plants, Fungi
9
11
Technology/Technique Development
Facility Construction/Improvement
12a Clinical Trials – Multicenter
16d
16e
16f
17
18
19
20
21
22
13
14
15
16a
16b
16c
23
24
25a
25b
25c
25d
26
Axis I: Anatomical Systems
Cardiovascular System
Connective Tissue
Endocrine System
Gastrointestinal System – Esophagus
Gastrointestinal System – Gallbladder
Gastrointestinal System – Intestine
Gastrointestinal System – Liver
Gastrointestinal System – Pancreas
Gastrointestinal System - Stomach
Hematological System
Integumentary/Skin System
Lymphatic and Reticulo-Endothelial System
Muscular System
Nervous System
Oral/Dental
Reproductive System
Respiratory System
Sensory System – Ear
Sensory System – Eye
Sensory System – Taste/Smell
Sensory System – Touch
Skeletal System

12b Clinical Trials – Single Center
12c Clinical Trials – Phase I
12d Clinical Trials – Phase I & II
12e Clinical Trials – Phase II
12f Clinical Trials – Phase II & III
12g Clinical Trials – Phase III
12h Clinical Trials – Phase III & IV
12i Clinical Trials – Phase IV
36
38
39
40
41
42
44
30
31
32
33
34
35
Aging
AIDS, SAIDS, HIV, SIV
Anesthesiology
Alternative Medicine
Anthropology/Ethnography
Arthritis
Behavior/Psychology/Social Science
Bioethics
Biotechnology (rDNA, cDNA, Hybridoma
Communication/Speech
Cognition/Learning
Computer Science
Congenital Defects or Malformation
45
46
48
49
Deafness/Hearing
Degenerative Disorders
Device/Prostheses, Intra/Extracorporeal
Diabetes
50a Drug/Therapeutic Agent Studies: Toxic
50b Drug/Therapeutic Agent Studies: Other
50c Drug/Therapeutic Agent Studies: Orphan
Drugs
51 Education
52 Engineering/Bioengineering
54a Environmental Sciences – Toxic Substances
54b Environmental Sciences – Other
55
56
57
58
59
Gene Therapy
Epidemiology
Fitness, Physical
Genetics, Including Metabolic Errors
Genome
27
28
Axis II : Research Area
60 Growth and Development
62 Health Care Applications
63a Imaging: CT
63b Imaging: Laser
63c Imaging: MRI, MRS
63d Imaging: NMR
63e Imaging: PET
63f Imaging: Spect
63g Imaging: Radiography
63h Imaging: Ultrasound
63I Imaging: Microscopy
63j Imaging: Near Infrared
64 Immunology and Allergy
65 Infant Mortality
66 Infectious Diseases
67 Nursing Care Research
68 Information Science
69 International Health
70 Instrument Development
71 Maternal and Child Health
Urinary System
Other (Specify)
82
83
84
85
86
87
88
74h Metabolism: Protein & Amino Acid
75a Minority Health: Asian/Pacific Islanders
75b Minority Health: Blacks
75c Minority Health: Hispanics
75d Minority Health: Native Americans
75e Minority Health: Other
76a Neoplasm/Oncology/Cancer - Benign
76b Neoplasm/Oncology/Cancer – Malignant
77 Model Development
78
79
80
81
Nutrition
Pain
Radiology/Radiation/Nuclear Medicine
Rare Disease
Rehabilitation
Sexually Transmitted Disease
Statistics/Mathematics
Sleep Research
Surgery
Substance Abuse
Transplantation
72 Mental Disorders/Psychiatry
73
Men’s Health
74a Metabolism: Carbohydrate
74b Metabolism: Electrolyte/Mineral
74c Metabolism: Enzymes
74d Metabolism: Gases
74e Metabolism: Hormone
74f Metabolism: Lipid
74g Metabolism: Nucleic Acid
89
90
91
92
93
94
95
Structural Biology
Trauma/Burns/Injury
Vaccine
Other (SPECIFY)
Women’s Health Research
Prevention
Transgenics
K.
FUNDING SUPPORT
You will need to provide information on all grant support for the PI and each Co-I listed on this protocol.
You can do this by copying and pasting NIH other support pages below.
Please do the following:
1.
List the grant(s) that support(s) this GCRC protocol here:
2.
Copy and paste your NIH other support pages for the PI and all Co-I’s here:.
6