Children’s Hospital Colorado (CHC Pediatric)
Clinical Translational Research Center (CTRC) Electronic Protocol Application
COMIRB Attachment U - CHC CTRC Utilization Form
Protocol Full Title
Protocol Short Title (limit 80 characters)
COMIRB #
Version Date:
Summary of Study Personnel
1.1 Principle Investigator: *Enter First Name, MI, Last Name
Degree:
Title:
Department: Enter PI’s department here
Phone #:
Email:
Pager #:
Campus Box:
ERA -Commons Name [Required]:
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
Phone #:
Email:
Pager # :
Campus Box:
Degree:
1.3 Co-Investigators:
First Name, Last Name,
Degree
ERA-commons
Name
REQUIRED
Email Address
Campus Box
Summary of Protocol
2.1 Proposed Study Subject Category:
Type A
Visits for investigator-initiated study and for RESEACH purposes only
Type 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 ________________________________________
Or
Multiple national/international sites?
Yes
No
If yes, list other sites and primary ________________________________________
COMIRB Attachment U – Pediatric CTRC Utilization Form
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2.3 Is this study AIDS/HIV related?
2.4 Is this a clinical trial?
Yes
Yes
No
No
If yes, 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/s to the CTRC Protocol Document Manager at:
ctrc.protocols@ucdenver.edu
2.6 Funding Source:
Is this study funded in part (or total) by a peer reviewed grant?
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?
Yes
No
If yes, what/who is the sponsoring entity and speedtype?
Funding agency ___________ 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?
2.7 Duration of Study:
What is the expected duration of this study?
2.8 Research at CHC:
Are you conducting research at CHC?
Yes
No
2.9 Privileges at CHC:
Do the PIs, SCs, etc. have privileges at CHC?
Yes
No
If no, please contact Laurie Blumberg-Romero and Theresa Watkins.
2.10 EPIC training:
Do you have a research coordinator trained in EPIC?
Yes
No
If no, please contact Laurie Blumberg-Romero and Theresa Watkins.
2.11 Ages of Patients Served: (Check all that apply)
Neonatal (<30 days)
Infancy (>30 days to <1 year)
Early childhood (>1 year to <5 years)
Late childhood (>5 years to <13 years) years)
Adolescent (>13 years to <17 years)
Adult (>17 years)
2.12 Justification for Utilization of UCH 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.)
COMIRB Attachment U – Pediatric CTRC Utilization Form
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Prior to submitting your application, contact Cindy Scott, 720-777-6644, cindy.scott@childrenscolorado.org
to discuss your request and confirm that CTRC funds are available to defray the associated costs.
Summary of Data and Safety Monitoring Plan
3.1 Summarize the Data and Safety Monitoring Plan (DSMP) for this protocol:
Enter information here after consultation with CHC Research Subject Advocate, reading the form and writing the
plan.
3.2 Child and Adolescent: Blood draw volumes in pediatric research participants. The amount of blood to be
drawn from pediatric research participants must be carefully monitored to assure that it does not pose excessive
risk to the pediatric participant. It is generally thought that drawing 7ml/kg over a period of 6 weeks is safe for
children. However, multiple considerations can make this level of blood volume loss unsafe or greater volumes
safe. Thus, we ask that investigators provide the details of all research volumes to be drawn with an estimate of
volumes routinely drawn (if possible) for care of children eligible for inclusion in the protocol. If blood draw
volumes exceed 7ml/kg for a 6 week period please provide a justification and any plan to prescribe supplemental
iron for participants. The Research Subject Advocate is available to help – 720-777-8529 – if you have questions.
Enter information here after consultation with CHC Research Subject Advocate
3.3 Describe SAEs and AEs for this protocol and the SAE/AE reporting plan:
Enter information here after consultation with CHC Research Subject Advocate
3.4 Describe both subject discontinuation criteria and protocol stopping criteria:
Enter information here after consultation with CHC Research Subject Advocate
3.5 Plans for assuring data accuracy and protocol compliance:
Enter information here after consultation with CHC Research Subject Advocate
Note: The requirement for a DSM Board will be determined by the Research Subject Advocate (RSA).
Review the DSMP Guidance at: http://cctsi.ucdenver.edu/Public%20Documents/DSMP_GUIDANCE.pdf
Summary of Requested CTRC Services
Complete and check only items that apply to your study.
4.1 Study Participants:
How many volunteers will have screening visits?____________
How many of the volunteers screened will participate in the study?________
4.2 Inpatient Admissions Required
4.2.1 Total expected number of subjects:
4.2.2 Expected number of subjects per year
4.2.3 Expected number of visits per subject:
4.2.4 Estimated duration per visit (in days)
4.2.5 Advance Practice nursing support required
_____
_____
_____
_____
4.3 Long Outpatient Stays on Inpatient Unit Required?
4.3.1 Total expected number of subjects:
4.3.2 Expected number of subjects per year:
4.3.3 Expected number of visits per subject:
4.3.4 Estimated duration per visit:
4.3.5 Advance Practice nursing support required
_____
_____
_____
_____
Yes
Yes
No
No
CONTACT Jeryl McGaw 303-929-8130
4.4 Outpatient Clinic/ Hospital-Wide Research Assistant (OPT/HRA)
COMIRB Attachment U – Pediatric CTRC Utilization Form
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4.4.1 Total expected number of subjects:
4.4.2 Expected number of visits per subject:
4.4.3 Estimated duration per visit:
4.4.4 Nursing support required:
4.4.5 Advance Practice nursing support required
4.4.6 Research Assistant Support Required
_____
_____
_____
Yes
Yes
Yes
No
No
No
CONTACT KC Clevenger 720-777-4529
4.5 Perinatal Scatter Bed Visits Required?
4.5.1 Expected number of pediatric patients:
4.5.2 Expected number encounters/patient:
4.5.3 Estimated duration per encounter:
4.5.4 Specify special requested nursing services:
_____
_____
_____
4.5.5 Where will patients be located (check all that apply):
Location:
UCH
CHC
DHMC
St. Joseph
Other
Other institution(s) if applicable: __________________________
Unit type:
Level 1
Level 2
Level 3
Ante/Postpartum
Other___________________
Labor and Delivery
CONTACT Christine Reed 720-777-4694
4.6 Cardiology Services Required?
4.6.1 Will CHC Cardiology be required to provide reporting of cardiac ultrasound studies? Yes_____ No___
CONTACT James Thorpe 720-777-5049
Research Nursing Services



Inpatient Nursing: Contact Jeryl McGaw at jeryl.mcgaw@childrenscolorado.org 303-929-8130.
OPT/HWRA Nursing: Contact KC Clevenger at kc.clevenger@childrenscolorado.org, 720-7774529.
Perinatal Nursing: Contact Christine Reed at christine.reed@childrenscolorado.org 720-777-4694
Check only items that apply
5.1 Inpatient Admissions Required
5.1.1 Will protocol require 1:1 nursing
Yes
No
5.1.2 Will the visits be done over the weekend
Yes
No
5.1.3 Are acute admissions required
Yes
No
If Yes, would they occur at night
Yes
No
Are there specific time constraints?
Yes
No (example: must complete visit within 3 weeks of
diagnosis)
Time constraints are _________________________________
5.1.4 Research nursing services required (please check)
Phlebotomy
Yes
No
Central line access
Yes
No
Blood Processing
Yes
No
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Medication Administration
Urine/Stool Collection
Food & Beverage Measurement
Sedation Recovery
Use of specialized equipment
5.1.5 What supplies are required? Please list:
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No (example: PCA pump)
Are the supplies a “Special order”
Yes
No
Who is paying for the supplies?
PI
CTRC
What is the total cost of the supplies (if requesting that CTRC pays) $________
5.1.6 Who will be obtaining specimens?
PI
SC
CTRC staff
Who will be processing the specimens?
PI
SC
CTRC staff
If CTRC will be processing-please list specifics:
Process samples within _________ minutes,
Samples can be batched
Use of centrifuge _______ temp, _______ speed, ______ time
Samples need to be aliquoted
Samples must go into cryovials
Specific labels will be required for samples
Yes
No
Samples will need to be transferred to ____________ for long term storage.
Who will transfer samples?
PI
SC
CTRC
5.1.7 Additional charting required besides EPIC
Yes
No
5.1.8 Other services?
5.2 Long Outpatient Stays on the Inpatient Unit
5.2.1 Length of each encounter (hours)
< = 1 Hour
1 to 3 Hours
3 or more hours
# of expected hours per subject ______________
5.2.2 Will protocol require 1:1 nursing
Yes
No
5.2.3 Will the visits be done over the weekend
Yes
No
5.2.4 Are acute admissions required
Yes
No
If Yes, would they occur at night
Yes
No
5.2.5 Are there specific time constraints?
Yes
No (example-must complete visit within 3 weeks of diagnosis)
Time constraints are _________________________________
5.2.6 Research nursing services required (please check)
Phlebotomy
Yes
No
Central line access
Yes
No
Blood Processing
Yes
No
Medication Administration
Yes
No
Urine/Stool Collection
Yes
No
Food & Beverage Measurement
Yes
No
Sedation Recovery
Yes
No
Use of specialized equipment
Yes
No (example-PCA pump)
5.2.7 What supplies are required? Please list:
Does the institution need to “Special Order” the supplies?
Yes
No
Who is paying for the supplies?
PI
CTRC
What is the total cost of the supplies (if requesting that CTRC pays) $________
5.2.8 Who will be obtaining specimens?
PI
SC
CTRC staff
Who will be processing the specimens?
PI
SC
CTRC staff
If CTRC will be processing-please list specifics
Process samples within _________ minutes,
Samples can be batched
Use of centrifuge _______ temp, _______ speed, ______ time
Samples need to be aliquoted
Samples must go into cryovials
Specific labels will be required for samples
Yes
No
Samples will need to be transferred to ____________ for long term storage.
Who will transfer samples?
PI
SC
CTRC
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5.2.9 Additional charting required besides EPIC?
Yes
No
5.3 Outpatient Clinic/ HWRA visits
5.3.1 Who will be screening for subjects?
PI
CTRC
5.3.2 Who will be consenting subjects?
PI
CTRC
5.3.3 Will visit occur in: (please check one)
CTRC clinic
Other clinic __________________
Locations other than clinic area ___________________
Length of each encounter (hours)
< = 1 Hour
1 to 3 Hours
3 or more hours
5.3.4 Are there questionnaires/who will complete them?
PI
CTRC
5.3.5 Will the protocol be implemented immediately after consenting
Yes
No
Or is there a wait time?
Immediately
Wait time
5.3.6 Will protocol require 1:1 nursing
Yes
No
5.3.7 Will the visits be done over the weekend
Yes
No
5.3.8 Are there specific time constraints?
Yes
No (example-must complete visit within 3 weeks of
diagnosis)
Time constraints are ______________________________
5.3.9 Research nursing services required (please check)
Phlebotomy
Yes
No
Central line access
Yes
No
Blood Processing
Yes
No
Medication Administration
Yes
No
Use of sedation
Yes
No
Urine/Stool Collection
Yes
No
Food & Beverage Measurement
Yes
No
Sedation Recovery
Yes
No
Use of specialized equipment (example-PCA pump)
Yes
No
Use of coordination services
Yes
No
5.3.10 What supplies are required? Please list:
Does the institution need to special order the supplies?
Yes
No
Who is paying for the supplies?
PI
CTRC
What is the total cost of the supplies (if requesting that CTRC pays) $________
5.3.11 Who will be obtaining specimens?
PI
SC
Staff RN
Who will be processing the specimens?
PI
SC
Staff RN
If CTRC will be processing-please list specifics
Process samples within _________ minutes,
Samples can be batched
Use of centrifuge _______ temp, _______ speed, ______ time
Samples need to be aliquoted
Samples must go into cryovials
Specific labels will be required for samples
Yes
Samples will need to be transferred to ____________ for long term storage.
Who will transfer samples?
PI
5.3.12 Requesting data management support?
Yes
5.3.13 Requesting follow up phone calls/ visits?
Yes
CTRC staff
CTRC staff
No
SC
No
No
CTRC
5.4 Perinatal Scatter Bed Visits
5.4.1 Are there specific time constraints?
5.4.2 Length of each encounter (hours)
< = 1 Hour
1 to 3 Hours
Yes
No (example-must complete visit within 3 weeks of diagnosis)
COMIRB Attachment U – Pediatric CTRC Utilization Form
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3 or more hours
# of expected hours per subject ______________
5.4.3 Will you need nursing services after 11pm or on weekends?
Please specify:
5.4.4 Research nursing services required (please check)
Screening
Consenting
Data Collection
Data Entry
Phlebotomy
Cord Blood Collection
Placental Dissection and processing
Blood processing
Isotope infusion
Medication administration
Urine/stool collection
Tracheal aspirate
Use of specialized equipment (i.e. PCA pump, PeaPod)
Nursing assessments (i.e. pain scores, neuro exams, etc)
If so, please specify:__________________________
Bailey exams
If so, at what time points? _________________________
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
5.4.5 What supplies are required? Please list:
Does the institution need to special order the supplies?
Yes
No
Who is paying for the supplies?
PI
CTRC
What is the total cost of the supplies (if requesting that CTRC pays) $________
5.4.6 Who will be obtaining specimens?
PI
SC
Staff RN
CTRC staff
Who will be processing the specimens?
PI
SC
Staff RN
CTRC staff
If CTRC will be processing-please list specifics
Process samples within _________ minutes,
Samples can be batched
Use of centrifuge _______ temp, _______ speed, ______ time
Samples need to be aliquoted
Samples must go into cryovials
Specific labels will be required for samples
Yes
No
Samples will need to be transferred to ____________ for long term storage.
Who will transfer samples?
PI
SC
CTRC
5.4.7 Requesting data management support?
Yes
No
5.4.8 Requesting follow up phone calls/ visits?
Yes
No
Nutrition Support Request
Important Note: If nutrition support is required, you must discuss your needs and confirm availability before
submitting your application. For CHC protocols, contact Dr. Janine Higgins at
janine.higgins@childrenscolorado.org, 720-777-2955.
6.1 Does your protocol require Nutrition support?
Yes
No (skip to next section)
6.2 If yes, please answer the following:
Check ALL that apply; if no category is checked, no Nutrition services will be provided for this protocol
Nutrient controlled diet (must complete section A)
Nutrient intake analysis (e.g., diet records, must complete section B)
Diet instruction or nutrition education (must complete section C)
Non-controlled snacks or beverages (e.g. snack following exercise test or RMR, availability of juice for
diabetics; must complete section A)
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Growth assessment: (e.g., skinfold, circumference, segment measures, etc.; must complete section D)
Indirect Calorimetry (must complete section E)
Physical activity questionnaire (must complete section F)
Dual X-Ray Absorptiometry (DEXA; must complete section G)
Other: Please specify:
6A. If you are requesting the provision of ANY foods or beverages, please answer the following:
Are any inpatient meals to be served
Yes
No
If yes, which visits?
(AIP)?
If yes, specify times that meals are to be
Snack
Breakfast
Lunch
Dinner
served.
Are any outpatient meals/diets to be
served?
If yes, at which visits? Specify the diet
duration (days or weeks) required at each
visit.
Will any ad lib food intake measurements be
performed (i.e. food weigh-back)?
Yes
No
Visit:
Duration:
Visit:
Duration:
Yes
No
Will a calorie controlled diet be used?
Yes
If yes, what is the purpose of providing a
nutrient controlled diet?
How will the target calorie level for each
participant be calculated?
Which of the following nutrients will be controlled in the diet:
CHO - Specify amount / ratio
Fat -- Amount / ratio
Protein – Amount / ratio
Fiber - Specify amount / ratio
Sugar -- Amount / ratio
Complex CHO/simple sugar ratio
Cholesterol – amount / ratio
Visit:
Duration:
No
Sodium -- Amount / ratio
Fatty acid subtype – amount/ratio w-6 fatty acids – amount / ratio
w-3 fatty acids – amount / ratio
Micronutrients – name, amount / ratio
Micronutrients – name, amount / ratio
Other
6B. 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?
3d diet diary
Food Frequency Questionnaire (FFQ)
24h diet recall
Photographic food records
Other. Specify:
6C. If you are requesting diet instruction or nutrition education, please answer the following:
What is the goal of the counseling session? (e.g.
weight loss, improve compliance, standard disease
dietary education, 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
COMIRB Attachment U – Pediatric CTRC Utilization Form
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Page 8 of 14
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
6D. If you are requesting growth assessment, please answer the following:
What specific parameters would you like
Height
measured? (Check ALL that apply)
Weight
Mid-arm circumference
Waist circumference
Tricep skinfold
At what time points would you like growth
assessed?
Do you require the calculation of z-scores?
Yes No
Bicep skinfold
Sub-scapula skinfold
Hip skinfold
Hip circumference
Other. Specify:
If yes, please explain
6E. If you are requesting indirect calorimetry (IC), please answer the following:
What is the purpose of IC?
RMR
Fat oxidation
Carbohydrate oxidation
Other. Specify:
At what time points would you like IC performed?
Does you study population have any special
medical needs that might hinder IC data collection
Yes No
If yes, please explain
(e.g. spasticity, TPN, etc)?
6F. If you are requesting physical activity (PA) questionnaires, please answer the following:
What specific parameters are you trying to assess?
(e.g. habitual activity, adherence to protocol, etc)
At what time points would you like PA assessed?
Which method of measurement will be used?
PDPAR
Activity Diary
24h activity recall
Other. Specify:
6G. If you are requesting DEXA, please answer the following:
What specific parameters are you trying to assess?
(e.g. fat mass, lean mass, change in fat mass, etc.)
At what time points would you like DEXA
performed?
Do you require any information other than that
Yes No
If yes, please explain
provided on the DEXA report?
Summary of CTRC Core Laboratory Tests and Analyses
CHC, UCH 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:
CHC Pediatric Core Lab 720-777-8100
Peggy Emmett,peggy.emmett@childrenscolorado.org
Hobbie Harrington, mary.harrington@childrenscolorado.org
UCH Adult CTRC 720-848-6667
COMIRB Attachment U – Pediatric CTRC Utilization Form
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Pam Allen, pamila.allen@ucdenver.edu
Kayla Carstens, kayla.carstens@ucdenver.edu
NJH CTRC 303-398-1658
Beth Canono, canonop@njh.org
7.1 Core Laboratory Tests – List all core laboratory tests required for completion of study:
Identify all tests that the grant/study funding will pay and all tests you are requesting the CTRC to pay.
Lab Site
# Tests/
Subject
Test Name
Total Tests
Requested
Requesting
CTRC pay?
(Yes or No)
7.1.A Core Lab Storage Information
How many samples will be stored?
__________
How long will these samples need to be stored?
__________
At what temperature are samples to be stored?
__________
When the time of storage has expired:
a.) who will arrange for shipping of samples
________________________
b.) who will pay for shipment of samples
________________________ c.) how will the samples be shipped?
________________________
Please note that prior arrangements must be made with the CHC CTRC Core Lab or samples may be destroyed if
they are not retrieved within 60 days after the end date for a study. The Core Lab will be happy to work with
anyone needing storage to make sure their needs are met. Please contact Peggy Emmett at 720-777-8100.
7.2 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: elaine.spector@ucdenver.edu, 303-724-3801.
Test Name
# Tests/
Subject
COMIRB Attachment U – Pediatric CTRC Utilization Form
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Total Tests
Requested
Requesting
CTRC pay?
(Yes or No)
Summary of Requested Neurodevelopmental/Neuropsychological Testingthrough the Neurodevelopmental Research Core (NDRC) at Children’s
The NDRC conducts a variety of developmental, behavioral and psychological assessments for pediatric clinical
research protocols. The NDRC also provides expert clinical research support during protocol development by
advising on the selection of neurodevelopmental assessments. Neurodevelopmental testing includes cognitive,
academic, attention, executive function, memory, language, sensory, visual-spatial and motor domains, as well as
adaptive skills, behavior and interviews.
**Important Note: Prior to submitting this application, you must discuss your needs with the NDRC’s Program
Manager (Lisa.Cordeiro@childrenscolorado.org (720-777-36200) if NDRC services may be required for your
study. You may also fill out our BRIEF inquiry form at http://j.mp/pauvFr to get more information and let us know
about your study.
Neurodevelopmental Research Core (NDRC)
Lisa Cordeiro, MS, Program Manager
Lisa.Cordeiro@childrenscolorado.org or 720.777.3620
8.1 Neurodevelopmental Tests – If known, list the names all tests required for completion of
study. For example, IQ tests or academic tests.
Identify all tests that the grant/study funding will pay and all tests you are requesting the CTRC to pay.
Test Name
(i.e. WISC-IV, Bayley-III, etc.)
# Tests per Subject
(i.e. 2 study visits=2
tests per subject)
Total # of Tests Requested
(i.e. 2 study visits= 2 tests
per subject X # of subjects)
Requesting
CTRC pay?
(Yes or No)
Summary of Requested Biostatistical Support
*Important Note: The CTRC statisticians can provide assistance with study design, estimates of statistical power,
and an analysis plan. Contact Jane Gralla at jane.gralla@ucdenver.edu, 303-724-4359
9.1 Biostatistic Services requested. Check only items that apply:
Study design
Sampling plan
Sample size calculations
Analytical support
Report, publication, presentation, conference planning
If a multi-center study, please provide contact information for Data Coordinating Center and Lead Biostatistician
COMIRB Attachment U – Pediatric CTRC Utilization Form
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Summary of Requested Research Informatics Services
10.1 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.
Summary of Research Subject Advocate Services
Contact Theresa O’Lonergan with questions at: theresa.o’lonergan@childrenscolorado.org, 720-777-8529
11.1 Which of the following RSA services did you or will you utilize? Check only items that apply.
Human subject risks and protection provisions?
DSMP/DSMB planning support?
Serious Adverse Event (SAE) definitions; procedures assistance?
HIPAA compliance?
Ethical, legal and social implications (ELSI) associated with this study?
Other?
Enter other RSA services requested here:
Summary of CHC Services Requested
12.1 Please indicate requests for additional services NOT provided through the CTRC but utilizing The
Children’s Hospital departments and services (i.e. radiology, clinical lab). These may be billed to your research
study funding.
CHC
Department
Name of Test or Procedure
# Tests/
Subject
Total Tests
Requested
Requesting CTRC
payment?
(Yes or No)
Summary of CHC Research Pharmacy Services
13.1 Please indicate requests for pharmacy services NOT provided through the CTRC but utilizing Children’s
Hospital Colorado Research Pharmacy. These costs may be billed to your research study funding.
Dispensing Procedure (e.g. PO, IV, compounding, compliance)
COMIRB Attachment U – Pediatric CTRC Utilization Form
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Number
per
Subject
Requesting CTRC
payment?
(Yes or No)
Will Randomization (telephone or list) be requested?
Summary of CHC Ultrasound Services
14.1 Please indicate requests for cardiology services.
What Ultrasound modalities will you require? (Check all that apply):
Duplex scan study “Carotid Artery”
Duplex scan study of “Brachial Artery”
Duplex scan of “Abdominal Aorta”
(2D) Two Dimensional Imaging “Cardiac”
Spectral Doppler Imaging “Cardiac”
Color Doppler Imaging “Cardiac”
Stress Echocardiology
Patient Demographics:
Duration of Study:
What is the expected duration of this study?
_____
Total expected number of subjects:
_____
Expected number of subjects per year
_____
Expected number of visits per subject:
_____
Length of each encounter (hours)
< = 1 Hour
1 to 3 Hours
3 or more hour’s
# of expected hours per subject ______________
Are there specific time constraints?
Will visits be done over weekends?
Will patient sedation be required?
Will nursing support be required?
Yes
Yes
Yes
Yes
No
No
No
No
Will the CHC CTRC be responsible for data analysis of ultrasound?
Yes
No
Will transfer of study data to the core lab be required?
Yes
No
How will studies be transferred to the core lab? _________________________________
Who will pay for transfer of study data to the core lab? ___________________________
Will protocols be initiated for assuring data accuracy and protocol compliance regarding off site ultrasound
investigators?
Yes
No
Who will be responsible for supervision quality assurance regarding off site ultrasound
investigators? _____________________________________________________.
COMIRB Attachment U – Pediatric CTRC Utilization Form
CF-110, Effective 9-21-2011
Page 13 of 14
What are the specific ultrasound indications for this study? ______________________________________
_____________________________________________________________________________________
What are the specific parameters that you would like measured in this protocol including 2D, M-mode,
Spectral Doppler, and Color Doppler? _____________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
What patient demographic information will you require for this protocol?
(Ht, Wt, BP, et cetera)_____________________________________________________________________
Will there be any special software tools or training needed?
Yes
No
If yes, please specify ____________________________________________________________________
Will there be any special supplies required?
Yes
No
If yes, please specify ____________________________________________________________________
Who will pay for special software, training, and supplies? ________________________
Will CHC Cardiology be required to provide reporting of cardiac ultrasound studies?
COMIRB Attachment U – Pediatric CTRC Utilization Form
CF-110, Effective 9-21-2011
Page 14 of 14
Yes
No