Request Type
* must provide value
New
Update
Closure
IRB# (Study Code)
* must provide value
Study Name
This should be a title preferred by the study team, it does not have to match the IRB name.
* must provide value
Once an Epic RSH record is closed it cannot be reactivated. Please verify that your study team has reconciled all billing activity associated with this study/fund. Before proceeding please confirm that all possible charge and late charge activity has been reconciled. Once you confirm this, we will process your closure request.
yes, I have confirmed all billing activity is complete
no, I have not yet confirmed this
yes, I have confirmed all billing activity is complete
no, I have not yet confirmed this
Have all participants been marked as Complete with an End Date in Epic?
Yes
No
What information needs to be updated (check all that apply)?
Is this study related to one of the research strategic initiative programs?
Yes
No
Please identify the specific program the study is associated with:
Pain
Perinatal Origins of Disease
Fertility Preservation
Precision Medicine - Oncology
Precision Medicine - Epilepsy
Precision Medicine - General
Pain
Perinatal Origins of Disease
Fertility Preservation
Precision Medicine - Oncology
Precision Medicine - Epilepsy
Precision Medicine - General
Interventional - Charge
Observational - Charge
Interventional - No Charge
Observational - No Charge
Interventional - Charge
Observational - Charge
Interventional - No Charge
Observational - No Charge
Interventional - Charge
Observational - Charge
Interventional - No Charge
Observational - No Charge
Interventional - Charge
Observational - Charge
Interventional - No Charge
Observational - No Charge
CHANGE to Grant ID number
CURRENT research fee schedule
Industry
Federal
CHANGE to research fee schedule
Industry
Federal
Please provide a brief description of what other updates need to be made to the RSH record
Study Type
* must provide value
Interventional - Charge: Participants receive interventions according to the research plan or protocol. Some/all charges may be billed to the study fund.
Observational - Charge: Investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions or procedures as part of their routine medical care, and participants may have study procedures (as in additional labs drawn or MRI sequences for research purposes). Some charges may be billed to the study fund.
Interventional - No Charge: Participants receive interventions according to the research plan or protocol. NO charges will be billed to the study fund.
Observational - No Charge: Investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions or procedures as part of their routine medical care. NO charges will be billed to the study fund.
Interventional - Charge: Participants receive interventions according to the research plan or protocol. Some/all charges may be billed to the study fund.
Observational - Charge: Investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions or procedures as part of their routine medical care, and participants may have study procedures (as in additional labs drawn or MRI sequences for research purposes). Some charges may be billed to the study fund.
Interventional - No Charge: Participants receive interventions according to the research plan or protocol. NO charges will be billed to the study fund.
Observational - No Charge: Investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions or procedures as part of their routine medical care. NO charges will be billed to the study fund.
Does this study have a ClinicalTrials.gov Identifier (NCT#)?
Note: This is required when the study meets the definition of an Applicable Clinical Trial per ClinicalTrials.gov. In addition, this identifier is required on insurance claims which have research related procedures billed to insurance.
* must provide value
Yes
No, it is not required
Yes
No, it is not required
The unique ID provided upon registration at ClinicalTrials.gov. (ex: NCT00000041)
How many participants are expected to be enrolled at Lurie Children's?
This number should match what is listed in the Cayuse IRB application, it may also be included in the clinical trial agreement with the sponsor.
Principal Investigator (PI)
* must provide value
Research Manager/Division Administrator
required if manager is performing billing review
Study Team MemberThis user will be notified of the Epic RSH Record status
* must provide value
Workday Grant ID
Example: GR1234567-01
* must provide value
Research Fee Schedule
* must provide value
Industry
Federal
Philanthropic or departmental funds should choose Federal.
Did you provide the ClinicalTrials.gov Identifier (NCT#) within this form?
Yes
No
Does this study utilize the Clinical Research Unit (CRU)?
Yes
No
If yes, the CTO will apply the CRU billing protocol to the RSH record.
Does your study use a second Workday grant number for this same study/IRB#?
Yes
No
Secondary Workday Grant #
Industry
Federal
Secondary Epic Study Name
Does your study use a third Workday grant number for this study/IRB#?
Yes
No
Industry
Federal
Is this study being conducted under an investigational device exemption (IDE)?
Yes
No
The OCCT will be reaching out to gather additional information related to this study.
To facilitate the process, please indicate the IDE#, if this is considered a Category A or Category B IDE study, and the product name, manufacturer and product code if available.
Grant ID# documentation is required for charge study types. Please provide one of the following:
Workday Grant ID notification or Workday award overview pdf OR A PDF of email approval from the Division Administrator for the use of an existing fund * must provide value
Current Lurie Children's IRB Approval or Acknowledgement Letter
* must provide value
IRB Closure Letter
* must provide value
Documentation of change request
* must provide value
IDE documentation
* must provide value
OCCT Additional Documentation
CTO staff may upload additional documentation if needed
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