University of Colorado Boulder

Clinical Translational Research Center (CTRC)

UCB CTRC Utilization Form

Protocol Full Title:

IRB #:

Version Date:

Summary of Study Personnel

1.1 Principal Investigator: *Enter First Name, MI, Last Name Degree:

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Department: *Enter PI department information here

PI Title:

ERA-Commons (Required):

Phone #: *PI phone number Email: *PI email address

Pager #: *PI pager number Campus Box: *Box #

Are you a CCTSI member? Yes No

[CCTSI membership is required: http://cctsi.ucdenver.edu/Pages/Membership.aspx]

1.2 *Information for Primary Contact Person If Other Than PI

Study Coordinator/Contact Name: *Enter First Name, Last Name Degree:

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Phone #: *Contact phone # Email: *Contact email address

Pager #: *Pager # Campus Box: *Box #

1.3 Co- Investigators:

First Name, Last Name, Degree / ERA-commons Name REQUIRED / Email Address

Summary of Protocol

2.1 Proposed Study Subject Category:

A Visits will be for investigator initiated RESEACH purposes only

B Visits for investigator initiated study and include a non-research patient care component

2.2 Is this a multi-site study? Yes No

Are the other sites local? Yes No

If yes, list other sites and primary site______

Or

Multiple national/international sites? Yes No

If yes, list other sites and primary site______

2.3 Is this study AIDS/HIV related? Yes No

2.4 Is this a clinical trial? Yes No

2.3.1 If so, please indicate phase ______

2.5 Has this research/protocol been reviewed by the Scientific Review Committee of any other CTSA site? Yes No

If Yes, please list the name of the CTSA______

Please send reviews from the other site to the CTRC Protocol Document Manager at:

2.6 Funding Source:

Is this study funded in part (or total) by peer reviewed grant funds? Yes No

If yes, what is the funding agency, grant number, and speedtype?

Funding Agency______Grant number______Speedtype______

Is this study funded in part (or in total) by industry funds? Yes No

If yes, what/who is the sponsoring entity?

Sponsor______Grant number______Speedtype______

2.6.1 If your study has no external funding, are you prepared to pay for costs over what the CTRC can support? If so, how?

2.6.2 MicroGrant Support Request: Yes No

Junior faculty (Assistant Professors and below), Post-docs, and Fellows are eligible to apply.

2.7 Duration of Study:

What is the expected duration of this study?

2.8 Justification for Utilization of UCB CTRC Resources:

Use of multiple CTRC resources is highly encouraged. Please thoroughly justify all resource requests including ancillary services (laboratory assays, radiology, pharmacy, respiratory therapy, etc)

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For assistance with budgeting and costs of requested services, please contact Nikki Leonardo CTRC Administrative Manager, 303-735-2521.

Summary of Requested UCB CTRC Services

Check and complete only items that apply to your study

3.1 Space Utilization

Contact the UCB nurse manager with questions: Debra Coady, 303-735-3056 UCB,

3.2 Enrollment Numbers:

3.2.1 Total number of subjects approved by local IRB:

3.3 Screening Visits

3.3.1 Total expected number of subjects you will screen:

3.3.2 Number of screening visits per patient:

3.3.3 Estimated duration per visit (in hours):

3.4 Inpatient Admissions

If this study requires Inpatient stays, please complete the appropriate UCH or Children’s Hospital CTRC Utilization forms to indicate where the participants will be admitted.http://cctsi.ucdenver.edu/Research-Resources/CTRCs/Pages/ProtocolSubmission.aspx

3.5 Outpatient Visits

3.5.1 Expected number of visits per subject (do not include screening visit)

3.5.2 Estimated duration per visit (in hours)

3.5.3 Provide additional details pertaining to outpatient visit if necessary

Summary of Requested Nursing Services

4.1 Inpatient and Outpatient Nursing Yes No Number per participant

Adipose tissue biopsy _____

Arterial catheterization & monitoring _____

BP monitoring _____

Cardio vascular monitoring _____

Electrocardiogram _____

Electroencephalogram _____

Endothelial cell harvesting _____

Fat Biopsy _____

History and Physical _____

IVGTT _____

Microneurography _____

Muscle biopsy _____

Oral meds administration _____

Phlebotomy _____

Venous catheterization _____

Pharmacological Infusion _____

IV or A-line

4.2 Integrative Physiology Core Lab (IPCL):

Contact the IPCL manager with questions: Mary Jo Reiling, 303-735-1377 UCB

Yes No

Accelerometer

Activity Question

Ankle Brachial Index

DEXA SCAN

Graded Exercise Testing

Heart Rate Monitor

Resting metabolic rate

Skin Folds

VO2 Max

Waist to Hip Ratio

4.3 Other Clinical Services Needed:

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Summary of Requested Nutrition Services (Available at UCB site)

*Important Note: Prior to submitting your application, if Nutrition support is required you must discuss your needs and confirm availability with contact Kathleen Farrell at the Boulder CTRC: , 303-735-2125. If requesting Denver CTRC support, please contact Dr. Janine Higgins as well at: Janine, 720-777-2955.

5.1 Does your protocol require Nutrition support? Yes No (skip to next section)

5.2 If yes, please answer the following

Check ALL that apply; if no category is checked, no Nutrition services will be provided for this protocol:

Non-controlled snack or post meal - e.g., snack following exercise test or RMR (< 2 hours for testing session) and post meal following an experimental session (> 4 hours experimental session), must complete section 5A)

Nutrient controlled research diet (must complete section 5A)

Nutrient intake analysis (e.g., diet records or food frequency questionnaire (FFQ), must complete section 5B)

Nutrition assessment, instruction or education (must complete section 5C)

Other. Please specify:

5.3A. If you are requesting the provision of ANY foods or beverages, please answer the following:

Are any outpatient SNACKS to be served? / Yes / No / If yes, which visits?
Are any outpatient POST MEALS to be served? / Yes / No / If yes, which visits?
Will a CALORIE CONTROLLED RESEARCH DIET be used? / Yes / No
If yes, what is the purpose of providing a RESEARCH DIET?
How will the target calorie level for each participant be calculated?
Which of the following nutrients will be controlled in the diet: Check ALL that apply
CHO - Specify amount / ratio / Sodium - Specify amount / ratio
Fat - Specify amount / ratio / Fatty Acid Subtype – Specify amount / ratio
Protein – Specify amount / ratio / w-6 Fatty Acids – Specify amount / ratio
Fiber - Specify amount / ratio / w-3 Fatty Acids – Specify amount / ratio
Sugar - Specify amount / ratio / Micronutrients – Name & Specify amount / ratio
Complex CHO/Simple Sugar - Specify amount / ratio / Micronutrients – Name & Specify amount / ratio
Cholesterol – Specify amount / ratio / Other

5.3B. If you are requesting nutrient intake analysis, please answer the following:

What specific dietary parameters would you like to assess? (e.g. kcal, protein, habitual macronutrient intake, etc.)
At what time points would you like diet assessed?
Which method of intake reporting will be used? / 3 or 4 Day Diet Record
Food Frequency Questionnaire (FFQ)
24 Hour Diet Recall
Other Specify:

5.3C. If you are requesting a nutrition assessment questionnaire, instruction or education, please answer the following:

Would like to have your subjects fill out a nutrition assessment questionnaire (NAQ) using REDCAP to screen for supplements, dietary intolerances, etc.? / Yes No
If yes, Nutrition department has a standard questionnaire, however, if you would like the NAQ to be tailored to meet your study’s dietary needs please specify.
What is the goal of the counseling session? (e.g., weight loss, low sodium, etc.)
At what time points will counseling be provided?
How long will each counseling session last?
Will you be providing core materials for counseling sessions? / Yes No
If no, please explain what materials will be required
Are the core materials obtained from/based on guidelines from a professional or government organization (e.g., ADA, Obesity Society, USDA, NIH)? / Yes No
If yes, please name the organization and source of the materials

Summary of Requested CTRC Core Laboratory Tests and Analyses

UCH, TCH and NJH Labs

*Important Note: Prior to submitting your application, if Core Lab tests are required you must discuss your needs and confirm availability with the respective Core Lab Manager:

TCH Pediatric CTRC Lab 720-777-8100

Peggy Emmett,

Hobbie Harrington,

UCH Adult CTRC Lab 720-848-6667

Pam Allen,

Kayla Carstens,

Boulder Community Hospital Lab 303-441-2169

For pricing Contact Delmira, Account #: Labclintrans

http://www.testcatalog.org/NRR/catalogs/BCH/catalog/TermsAndConditionsFrameset.aspx?session=true

6.1 Laboratory Tests – List all laboratory tests required for completion of study:

Identify all tests that the grant/study funding will pay and indicate the tests you are requesting the CTRC MicroGrant to pay (if eligible and awarded):

Lab Site / Test Name / Number of
Tests per Subject / Total
Tests Requested / PI or MicroGrant Paid
(PI or MG)

6.2 Request for Sample Processing (this is for processing lab tests sent to protocol specific Labs)

Indicate the # of samples per patient that need storage:

Are you requesting long term storage (> 2 months)? Yes No

6.3 UCD DNA Diagnostics Laboratory Tests and Analyses

Important Note: Prior to submitting your application, if DNA tests are required you must discuss your needs and confirm availability with Dr. Elaine Spector at: , 303-724-3801.

Summary of Requested Biostatistics Services

7.1 Biostatistic Services

Contact site CTRC biostatistician, , 303-735-5158

Study design support

Sampling plan support

Sample size calculations

Analytical support

Software tool selection/training

Report, publication, presentation, conference preparation

Other

Did you consult the CTRC Biostatistician during the design of your research protocol? Yes No

If it were available, would you request assistance with the analysis of your study data? Yes No

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Summary of Requested Research Subject Advocate Services

Contact Dr. William Byrnes with questions at: 303-735-2521.

8.1 Which of the following RSA services did you or will you utilize? Check only items that apply.

Human subjects risks, study alternatives, protections and mitigation support

Data safety monitoring plan development

Development of the informed consent document

Establishment of a data safety and monitoring board or safety officer

Serious adverse events (SAE) definitions, procedures, assistance

HIPAA compliance

Ethical, legal and social implications (ELSI) associated with this study

Standard Operating Procedures for GCP

Data Safety Monitoring Board or Safety Officer Charter templates

Other (list)

Summary of Informatics & Computer Support

Research Informatics offers data management tools and consulting, e.g. REDCap; as well as operational support such as directory space and Sharepoint team sites and Bioinformatics tool consulting services. For a complete listing of available services, please go to http://tinyurl.com/2ekgtnc.

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