Please note - as of Wednesday, February 5, 2014 - all new studies must be entered into Children's Research Management System (CRMS) (instead of emailing a scanned ONA form) in order to be considered for Research Institute Set-Up/Approval.
The Principal Investigator and his/her team is responsible for completing and submitting the following information into the Children's Research Management System (CRMS):
- Operational Needs Assessment: The operational needs assessment includes vital information that either helps us manage our research enterprise, is required by law, or both.
- Study Budget: A comprehensive budget that identifies all expenses as well as sources of support. This budget may be uploaded as an excel or pdf document in the Budget section of CRMS. In late March 2014, we will have full budgeting capabilities available in CRMS.
- IRB: If the study involves human subjects, then the full COMIRB or WIRB approval packet must be uploaded to CRMS prior to Epic activation using the "Upload IRB Documents" utility.
Once a project is approved, be sure to execute the "IRB Approved" utility on your study's CRMS workspace in order to let the Research Institute know that IRB review has been completed.
It is highly recommended that project teams upload their IRB application as soon as possible (to expedite Research Institute setup).
- Proposal or Contract: A proposal, subcontract (in the case of a grant) or a draft contract (in the case of an industry study) must be uploaded to CRMS to be signed by a Children's Hospital Colorado signing authority. You may upload a document for review using the "Upload Document for Review" creator on your project's CRMS workspace.
- Ancillary Department Services: In the event that the study involves ancillaries, create a Research Service Requests (RSRs) for each service to assure that the proper tests are performed and the correct study account is charged. Examples of Ancillary Departments are: Lab, Radiology, Cardiology, etc. Be sure to upload draft RSRs and final RSRs into CRMS using the "Upload RSR Documents activity on your project workspace.
Part of the approval process includes creating an Epic use plan and the financial set up.
Epic Use Plan (EUP): Upon IRB approval, the Principal Investigator/Team will meet with a member of the Electronic Medical Record (EMR) group to create an Epic use plan. Depending on the complexity of the study or the number of questions from the Epic user(s), this can be a brief or extended meeting. Think of it as an operating room “timeout." Before we start using our medical record for this study, does everyone know their role and responsibilities? Does everyone know where they can go for help? Are there any technical enhancements or modifications we can make to Epic that would make the study go smoother and avoid errors? Etc. Did you know you can schedule your Epic Use Plan in CRMS? Just use the activity "Schedule Epic Use Plan" on your study workspace!
PeopleSoft and Kronos Set-Up: Once the agreements with the sponsor are in place, the Research Institute will set up an account in PeopleSoft and place a Kronos request to recognize the new account.
Need Pre-Award Spending Approval?
Send the following documents to ResearchApproval@childrenscolorado.org with the PI name and "Pre-Award request" in your subject Line:
- Signed Pre-Award Request
- Proposed budget
- Draft or template contract (if applicable)
- Notice of Grant Award (NGA) from prime recipient (if applicable)