University of Colorado
National Jewish Center
Adult General Clinical Research Center
Protocol Application Guidelines
General Submission Information
Following are the guidelines for completing and submitting a protocol to the General Clinical Research
Center (GCRC). Download the protocol form from the GCRC website each time you submit a new
protocol as updates are made to the application periodically. The protocol will be reviewed by the
Scientific Advisory Committee (SAC) at the next monthly meeting, if submitted by the deadline. The
SAC schedule is available on our web page at:
http://www.uchsc.edu/ctrsinst/gcrc/admin.htm#99Deadlines.
Instructions for Health Sciences Center Protocols
Protocols are reviewed for both scientific merit and for GCRC resource requests. If you are at the Health
Sciences Center, please contact our Administrator, Tammy Manyik, at 303-372-8801 or email her at
Tammy.Manyik@uchsc.edu with any questions. Protocols must be submitted electronically, either by
email to Sandy.Cannon@uchsc.edu or on disk, and must be received by the GCRC by 5pm on the
deadline. The administrative offices are located on floor 8 West of University Hospital, Room 8120. The
GCRC Administrative Assistant can be reached at 303-372-8799.
Instructions for National Jewish Center Protocols
Protocols are reviewed by the Program Director and Administrative Manager for GCRC resource requests
prior to submission to the Scientific Advisory Committee. Please contact Jody Ciacco at 303-398-1717
or email her at ciaccoj@njc.org with any questions. Protocols must be submitted electronically, either
by email to Jody at ciaccoj@njc.org, or on disk, and must be received by 5pm on the deadline. The
administrative offices are located in room K-824 in the Goodman Building.
Credit on Publications
Principal and Co-Principal Investigators are required to cite the GCRC grant number (MO1-RR00051) in
all publications that result from research utilizing any GCRC resources, and copies of all publications
must be sent to the GCRC. Continued funding of the GCRC is dependent on the scientific publications
that result from our support.
Application Completion Instructions
Cover Page
Please complete all information requested on the Cover Page (the first page of the protocol application
form). Do not fill in the Protocol Number until one is assigned by the GCRC. The assigned number will
appear in the letter you will receive from the Scientific Advisory Committee after the initial review of the
protocol. Once a protocol number has been assigned, please include it on future correspondence with the
GCRC.
Type of Study:
Category A – this category is for patients that will be seen for research purposes ONLY, for
studies that are investigator-initiated.
Category B – this category includes patients who require hospitalization or outpatient studies for
diagnosis or treatment according to established standards of care. Although these patients
participate in GCRC-based research studies, the cost of non-research care cannot be charged to
the GCRC.
Category D – this category is for Industry-initiated studies. All Category D studies must submit
a budget and three copies of the industry protocol in addition to the GCRC application.
Part I Study Proposal: This part of the application is your scientific study proposal. The study
proposal (sections I - IV below) is limited to 5 pages.
I.
II.
III.
IV.
Hypothesis & Specific Aims: Your hypothesis should be a brief, testable research question.
Specific Aims should address the information you hope to gain from the study, and the clinical
implications (e.g. diagnosis, prevention, treatment).
Background & Significance: Provide a brief background of the disease or condition being
studied, previous research in this area, and the contribution that the proposed study would make.
Progress Report / Preliminary Studies: If this is a continuing study provide a progress report. If
this is a new study, describe any work that you have done in this area that has prepared you to
carry out the proposed study. Include pilot studies or prior studies by the principal investigator
that have laid the foundation for the proposed research study.
Research Design & Methods: Provide an in-depth narrative of your research design and the
methodology to be employed.
Data Analysis and Statistical Design – It is advisable to consult the GCRC statistician
regarding your data analysis and statistical design prior to submitting your protocol.
 Sample Size Justification: You must address the statistical determination of your proposed
sample size, and the power you expect to obtain.
 Analysis Plan: Include a description of your plan for analyzing your results, including the
outcome measures you will examine, how you will collect data, and the statistical tests you
will employ. Also address how you will treat outliers and dropouts.
The following must be included, but are outside of the 5 page limit:
V.
Human Subjects Address the following six points:
1. Description of Study Population – Provide a detailed description of the characteristics of the
subject population, including number, age, and health status. Identify the inclusion and exclusion
criteria, and explain the rationale for involvement of classes of subjects who are likely to be
vulnerable.
2. Sources of Research Materials – Identify the sources of research material obtained from
individually identifiable living human subjects in the form of specimens, records, or data, and
whether the material will be obtained specifically for research purposes or will be obtained from
previously collected materials.
3. Subject Recruitment and Consent Procedures – Describe plans for recruitment of subjects and
consent procedures. Describe when consent will be obtained, who will seek it, the information to
be provided, and method of documenting consent.
4. Potential Risks and Alternative Treatments – Describe potential risks (physical, mental, social,
legal or other) and their likelihood/seriousness, as well as alternative treatments and procedures.
5. Procedures for Minimizing Risks – Describe procedures for protecting against or minimizing
potential risks, assess their likely effectiveness, and discuss provisions for intervention in an
adverse event. Describe provisions for monitoring data and ensuring the safety of subjects.
6. Risk/Benefit Analysis – Discuss why the risks to subjects are reasonable in relation to the
anticipated benefits and in relation to the importance of the knowledge that may reasonably be
expected to result.
VI.
Gender and Ethnicity
Three tables regarding gender and ethnicity data must be completed. Table 1 is the national demographic
distribution in percentages of the disease being studied. Table 2 should indicate the patient distribution
you would expect in your study if no special recruitment is done, based on a) the patients recruited into
this protocol to date, b) the recruitment into a forerunner of this protocol, c) the demographic distribution
of your study population seen at the hospital, or d) the demographic distribution of your study population
in the city or state. Table 1 and Table 2 should both total 100%.
Table 1 and Table 2 should then be compared, and if Table 2 has numbers that are significantly different
from Table 1 for minorities or women, then a plan should be described that will appropriately increase the
participation of the relevant groups. Table 3 should contain your anticipated enrollment in the study, as
numbers of subjects rather than percentages.
You will need to site the source of information for both tables 1 and 2.
Tables of many disease-specific distributions can be found at the web address below, under FASTATS AZ: http://www.cdc.gov/nchswww/
General demographic data for the United States can be found at http://www.census.gov
VII.
Justification for Utilization of GCRC Resources
Please provide a justification that details why the GCRC is necessary to the completion of your proposed
study. Justifications can include the expertise of staff, equipment or facilities that are only available on
the GCRC, laboratory assays that are only performed in the GCRC Core Laboratory, etc.
VIII. Bibliography
Include a list of references and literature citations to support your background information. All authors
should be included.
Consent Form
You must submit a copy of your consent form even if it has not yet been COMIRB approved. An
approved COMIRB consent form and a COMIRB approval form are required before subjects can be
enrolled in your study.
Part II Protocol Application
The Protocol Application is used by the administrative staff to collect information about your proposed
study and utilization of GCRC resources. Please complete all sections of this application.
Projected Utilization of the GCRC
The GCRC offers resources that include inpatient beds, an outpatient clinic, a research kitchen, whole
room calorimeter, core laboratory, informatics/computer & biostatistical services. It is advisable that you
discuss your needs with the appropriate GCRC staff prior to submitting your protocol, so that our staff
may assist you and determine the feasibility of your request.
Indicate the types of visits you will be using on the GCRC:
1. Screening Visits: The patient is typically seen for a short visit in the outpatient clinic.
2. Outpatient Clinic Visits: The patient is seen in the GCRC outpatient clinic, and no inpatient bed or
inpatient nursing staff is utilized.
3. Short Stay on the Inpatient Unit: The patient is seen on the inpatient unit, and a bed must be
scheduled just as for an inpatient admission. However, the patient will not occupy a bed at midnight,
and we must count this as an outpatient visit. An example would be a visit for an Intravenous
Glucose Tolerance Test, where the patient arrives on the unit at 6am, occupies an inpatient bed, and
leaves the unit at 6pm. Please count all visits of this type as ‘outpatient’ as you complete the GCRC
utilization section.
4. Inpatient Admissions: The patient will stay in a bed on the inpatient unit, and the visit will be
overnight. “Overnight” is defined as occupying a bed at midnight.
If you are not sure how to classify your visits, please call Tammy Manyik at 372-8801 to discuss your
study needs.
Brief Summary: Please provide a brief summary (250-400 words) of your study in language easily
understood by the public, including background information, why the study is being performed, what
drugs/interventions are being studied, targeted populations, how subjects are assigned to groups, and the
primary/secondary outcomes.
Funding Support
Complete the requested information for all grant support for the Principal Investigator and all coinvestigators on this protocol. It is important tat you indicate which funding sources support your
submitted protocol.
Axis Codes
Please check off a minimum of 1 to a maximum of 6 axis codes from each of the three Axis areas.
**Any protocols submitted without the information requested here may be returned for completion, and
review will be delayed until the next review cycle.