Today's Date
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Today M-D-Y
IRB Number:
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Title of Study
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Nickname of study
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Ex: Pediatric Heart Transplantation: Transitioning to Adult Care = TRANSIT
Department
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Principal Investigator
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PI Email
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Box Number
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Phone Number
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Are there CRPs or other contact personnel?
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Yes No
Coordinator Name:
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Coordinator Department:
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Coordinator Phone Number:
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Email
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Additional Study Team Contact to Include?
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Yes
No
Additional Contact Name:
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Additional Contact Department:
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Additional Contact Phone Number:
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Additional Contact Email:
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Is this study multi-center?
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Yes No
Lead Site Name:
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Pharmaceutical Company Associated with Project
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Yes (Please specify):
Not Applicable
Pharmaceutical Company Name Associated with Project:
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NIH Grant Number:
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NIH Grant Number Not Known:
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N/A
The study team will update the Cardiopulmonary Lab once this number is known.
Workday Grant (GR) or gift (GFT) ID:
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Fund Number Not Known:
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N/A
The study team will update the Cardiopulmonary Lab once this number is known.
Is the test clinically indicated and therefore clinically paid? (Standard of Care)
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Yes No
'Yes' indicates the tests will be billed to patient insurance
Is there a funding source for the test(s)?
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Yes No
What is the funding source?
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Is there a cardiologist investigator associated with the research study?
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Yes No
Who is the cardiologist?
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(last, first)
Is there a pulmonologist associated with the research study?
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Yes No
Who is the pulmonologist?
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(last, first)
Anticipated Start Date of Study:
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Today M-D-Y
Length of Study/Active Recruitment Follow-Up:
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Anticipated Number of Participants:
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Is there more than one study visit per participant that will require our support more than once?
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Yes No
Length of participation per active participant:
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Will study results be sent to a centralized reading center (core lab) or interpreted by Lurie Children's Cardiologists?
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Centralized Reading Center/Core Lab Lurie Cardiologists
Where is the reading center/core lab?
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How will tests/images be transferred to the core lab?
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What method will you be using to transfer tests/images?
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Name of Site
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Are you screening for congenital heart disease?
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Yes No
What cardiology and/or pulmonary equipment does your protocol utilize?
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What other cardiology research equipment is needed?
What other pulmonary research equipment is needed?
Will your Complete 2D Echo/Doppler exam utilize a special protocol or should the standard procedure be used?
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Special Protocol Standard Protocol N/A
Number of Complete 2D/Echo Doppler exams per patient for the duration of the study:
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Will your Limited 2D Echo/Doppler utilize a special protocol or should a standard procedure be used?
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Special Protocol Standard Protocol N/A
Number of Limited 2D Echo/Doppler exams per patient for the duration of the study:
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Does your protocol recommend the same technologist and/or same scanner perform echo imaging throughout the study?
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Yes
No
Will your ECG/EKG exams utilize a special protocol or should a standard procedure be used?
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Special Protocol Standard Protocol N/A
Number of ECG/EKG exams per patient for the duration of the study:
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Does your protocol recommend the same ECG technologist and/or same scanner perform testing throughout the study?
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Yes
No
Will your Cardiac Stress Test utilize a special protocol or should a standard procedure be used?
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Special Protocol Standard Protocol N/A
Number of Cardiac Stress Tests per patient for the duration of the study:
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Will your Pulmonary Stress Tests exams utilize a special protocol or should a standard protocol be used?
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Special Protocol Standard Protocol N/A
Number of Pulmonary Stress Tests exams per patient for the duration of the study:
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Will your Excerise Test for Bronchospam (Spirometry) utilize a special protocol or should a standard protocol be used?
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Special Protocol Standard Protocol N/A
Number of Exercise Tests for Bronchospasm (Spirometry) per patient for the duration of the study:
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Will your Holter Monitor exams utilize a special protocol or should the standard procedure be used?
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Standard Protocol Special Protocol N/A
Number of Holter Monitor exams per patient for the duration of the study:
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Will your other indicated exams utilize a special protocol or should the standard procedure be used?
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Standard Protocol Special Protocol N/A
Number of other indicated exams per patient for the duration of the study:
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Will your spirometry exams utilize a special protocol or should the standard procedure be used?
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Standard Protocol Special Protocol N/A
Number of spirometry exams per patient for the duration of the study:
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Will specific training need to be taught based on study protocol?
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Yes No
Indicate pages of protocol outlining specific training needs:
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(certifications, modules, etc)
Will practice exams be needed?
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Yes No
Explain practice exams needed:
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Describe your goals associated with utilizing research echos:
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Attach your protocol
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Attach additional documents
Attach additional documents