Children's Hospital Colorado

Investigator Start-Up Process

Primary contact for investigator start-up resources

Contact: Aaron Mobley, Research Support Specialist

  • Do you need to access the Children's Research Management System (CRMS) or need to sign up for CRMS training? Visit our CRMS page for training dates or email for help logging in.
  • Want to get started with a study on the Anschutz Medical Campus? A centralized application is available for any and all resources needed on the Anschutz Campus! For updates and additional information, please visit the Human Subject Research Protocol Submission Portal.

After your basic information is entered in the campus-wide Portal, we will manage study start up through the Children's Research Management System.

Next steps: submitting your information

The Principal Investigator and his/her team is responsible for completing and submitting the following information into the Children's Research Management System (CRMS):

  1. Operational Needs Assessment: The operational needs assessment includes vital information that either helps us manage our research enterprise, is required by law, or both.
  2. 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 using the "Supporting Documents" activity available on your study workspace in CRMS. In late 2014, we will have full budget building capabilities available in CRMS.
  3. IRB Information: If the study involves human subjects, then the appropriate COMIRB or WIRB documents and approval packet must be uploaded to CRMS prior to Epic activation using the "IRB Approved" activity. We highly recommend project teams upload their IRB application as soon as possible (to expedite Research Institute setup).

If applicable:

  1. 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.  Please keep in mind that this activity is for documents that need to be reviewed by contract specialists and signed by a CHCO hospital signing authority.
  2. Schedule Epic Use Plan: If you are consenting patients, you need an Epic Use Plan. You can now schedule this in CRMS! Simply use the "Schedule Epic Use Plan" activity on your study 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.