Children’s Hospital Colorado (CHCO Pediatric)
Clinical Translational ResearchCenter (CTRC) Electronic Protocol Application
COMIRB Attachment U - CHCO 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:
1.2 Information for Primary Contact Person If Other Than PI
Study Coordinator/Contact Name: *Enter First Name, Last Name Degree:
Phone #:Email:
Pager #:Campus Box:
1.3 Co-Investigators:
First Name, Last Name, Degree / ERA-commons NameREQUIRED / Email Address / Campus Box
Summary of Protocol
2.1 Proposed Study Subject Category:
Type A Visits for investigator-initiated study and for RESEARCH 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 ______
2.3 Is this study AIDS/HIV related? Yes No
2.4 Is this a clinical trial? Yes NoIf 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:
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 ______
2.6.1If your study has no external funding, are you prepared to pay for costs over what the CTRC can support? If so, how?
2.6.2MicroGrant 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 Research at CHCO:
Are you conducting research at CHCO? Yes No
2.9 Privileges at CHCO:
Do the PIs, SCs, etc. have privileges at CHCO? Yes No
If no, please contact Theresa Watkins.
2.10 EPIC training:
Do you have a research coordinator trained in EPIC? Yes No
If no, please contact Theresa Watkins.
2.11Ages 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 CHCO CTRC Resources:
Please thoroughly justify all resource requests including ancillary services (laboratory assays, radiology, pharmacy, respiratory therapy, etc.)
Prior to submitting your application, contact Cassie Harvey, 720-777-2896
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 CHCO 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. Dr. Barbara Hammack, the Research Subject Advocate is available to help – 720-848-6662– if you have questions.
Enter information here after consultation with CHCO Research Subject Advocate
3.3 Describe SAEs and AEs for this protocol and the SAE/AE reporting plan:
Enter information here after consultation with CHCO Research Subject Advocate
3.4 Describe both subject discontinuation criteria and protocol stopping criteria:
Enter information here after consultation with CHCO Research Subject Advocate
3.5 Plans for assuring data accuracy and protocol compliance:
Enter information here after consultation with CHCO Research Subject Advocate
Note: The requirement for a DSM Board will be determined by the Research Subject Advocate (RSA).
Review the DSMP Guidance at:
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 Yes No
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 No
CONTACT KC Clevenger 720-777-4529
4.4Outpatient Clinic/ Hospital-Wide Research Assistant (OPT/HRA)
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: Yes No
4.4.5 Advance Practice nursing support required Yes No
4.4.6 Research Assistant Support Required Yes 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: UCHCHCO DHMC St. Joseph Other
Other institution(s) if applicable: ______
Unit type: Level 1Level 2 Level 3Labor and Delivery
Ante/Postpartum Other______
CONTACT Christine Reed 720-777-4694
4.6Cardiology Services Required?
4.6.1 Will CHCO Cardiology be required to provide reporting of cardiac ultrasound studies? Yes_____ No___
CONTACT Pam Allen 720-848-6665
Research Nursing Services
- Pediatric Clinical Support: Contact KC Clevenger at , 720-777-4529.
- Perinatal Nursing: Contact Christine Reed at 720-777-4694
Check only items that apply
5.1 Inpatient Admissions Required
5.1.1Will protocol require 1:1 nursing Yes No
5.1.2Will the visits be done over the weekend Yes No
5.1.3Are 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 ______
5.1.4Research 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)
5.1.5What supplies are required? Please list:
Are the supplies a “Special order” Yes No
Who is paying for the supplies? PIMicroGrant
What is the total cost of the supplies (if requesting that a MicroGrantpays) $______
5.1.6Who 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
5.1.7Additional charting required besides EPIC Yes No
5.1.8Other services?
5.2 Long Outpatient Stays on the Inpatient Unit
5.2.1Length of each encounter (hours)
< = 1 Hour
1 to 3 Hours
3 or more hours# of expected hours per subject ______
5.2.2Will protocol require 1:1 nursing Yes No
5.2.3Will the visits be done over the weekend Yes No
5.2.4Are acute admissions required Yes No
If Yes, would they occur at night Yes No
5.2.5Are there specific time constraints? Yes No (example-must complete visit within 3 weeks of diagnosis)
Time constraints are ______
5.2.6Research 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)
5.2.7What supplies are required? Please list:
Does the institution need to “Special Order” the supplies? Yes No
Who is paying for the supplies? PIMicroGrant
What is the total cost of the supplies (if requesting that a MicroGrantpays) $______
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
5.2.9Additional charting required besides EPIC? Yes No
5.3 Outpatient Clinic/ HWRA visits
5.3.1Who will be screening for subjects? PI CTRC
5.3.2Who will be consenting subjects? PI CTRC
5.3.3Will 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
5.3.4Are there questionnaires/who will complete them? PI CTRC
5.3.5Will the protocol be implemented immediately after consenting Yes No
Or is there a wait time? Immediately Wait time
5.3.6Will protocol require 1:1 nursing Yes No
5.3.7Will the visits be done over the weekend Yes No
5.3.8Are there specific time constraints? Yes No (example-must complete visit within 3 weeks of diagnosis)
Time constraints are ______
5.3.9Research 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? PIMicroGrant
What is the total cost of the supplies (if requesting that a MicroGrantpays) $______
5.3.11Who 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
5.3.12 Requesting data management support? Yes No
5.3.13 Requesting follow up phone calls/ visits? Yes No
5.4 Perinatal Scatter Bed Visits
5.4.1Are there specific time constraints? Yes No (example-must complete visit within 3 weeks of diagnosis)
5.4.2Length of each encounter (hours)
< = 1 Hour
1 to 3 Hours
3 or more hours # of expected hours per subject ______
5.4.3Will you need nursing services after 11pm or on weekends? Yes No
Please specify:
5.4.4Research nursing services required (please check)
Screening Yes No
Consenting Yes No
Data Collection Yes No
Data Entry Yes No
Phlebotomy Yes No
Cord Blood Collection Yes No
Placental Dissection and processing Yes No
Blood processing Yes No
Isotope infusion Yes No
Medication administration Yes No
Urine/stool collection Yes No
Tracheal aspirate Yes No
Use of specialized equipment(i.e. PCA pump, PeaPod) Yes No
Nursing assessments (i.e. pain scores, neuro exams, etc) Yes No
If so, please specify:______
Bailey exams Yes No
If so, at what time points? ______
5.4.5What supplies are required? Please list:
Does the institution need to special order the supplies? Yes No
Who is paying for the supplies? PIMicroGrant
What is the total cost of the supplies (if requesting that a MicroGrant pays) $______
5.4.6Who 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
5.4.8Requesting 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 CHCO protocols, contact Dr. Janine Higgins at , 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)
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 (AIP)? / Yes / No / If yes, which visits?If yes, specify times that meals are to be served. / Breakfast / Lunch / Dinner / Snack
Are any outpatient meals/diets to be served? / Yes / No
If yes, at which visits? Specify the diet duration (days or weeks) required at each visit. / Visit:
Duration: / Visit:
Duration: / Visit:
Duration:
Will any ad lib food intake measurements be performed (i.e. food weigh-back)? / Yes / No
Will a calorie controlled diet be used? / Yes / No
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 / Sodium -- Amount / ratio
Fat -- Amount / ratio / Fatty acid subtype – amount/ratio -
Protein – Amount / ratio / w-6 fatty acids – amount / ratio
Fiber - Specify amount / ratio / w-3 fatty acids – amount / ratio
Sugar -- Amount / ratio / Micronutrients – name, amount / ratio
Complex CHO/simple sugar ratio / Micronutrients – name, amount / ratio
Cholesterol – 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 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 measured? (Check ALL that apply) / HeightWeight
Mid-arm circumference
Waist circumference
Tricep skinfold / Bicep skinfold
Sub-scapula skinfold
Hip skinfold
Hip circumference
Other. Specify:
At what time points would you like growth assessed?
Do you require the calculation of z-scores? / Yes No / If yes, please explain
6E. If you are requesting indirect calorimetry (IC), please answer the following:
What is the purpose of IC? / RMRFat 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 (e.g. spasticity, TPN, etc)? / Yes No
If yes, please explain
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 provided on the DEXA report? / Yes No
If yes, please explain
Summary of CTRC Core Laboratory Tests and Analyses
CHCO, 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:
CHCO Pediatric Core Lab 720-777-8100
Peggy Emmett,
Hobbie Harrington,
UCH Adult CTRC 720-848-6667
Pam Allen,
Kayla Carstens,
NJH CTRC 303-398-1658
Beth Canono,
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 MicroGrantto pay (if eligible and awarded):