Pre-award financial services
The Children's Clinical Research Organization (CCRO) structure integrates key services essential to conducting clinical research and consists of the following resources that can be utilized in their entirety or as an individual service depending on your research needs.
- Research start-up: The CCRO provides services to help investigators navigate the Children's Hospital Colorado (CHCO) research start-up process, including dedicated personnel to assist with all study initiation requirements. (See below for more information on the CHCO research start-up process.)
- Clinical research coordination: The Clinical Research Coordinator (CRC) team is composed of skilled specialists in the coordination of clinical research for industry, federal, non-profit and investigator-initiated studies. The CRCs are trained and monitored for adherence to standard operating procedures, as well as external regulations. The CRCs provide a wide array of support, including study initiation, screening and recruitment, consenting, patient management, identification and reporting of adverse events, phlebotomy and drug administration (as appropriate and according to licensure), specimen processing and shipment, monitoring of patient compliance, data entry and query response, coordination of preparation for sponsor monitor visits and collaboration and coordination of ancillary services.
- Research project management: The CCRO supports investigators and institutions with project management and coordination of multi-center studies.
- Regulatory services: The CCRO regulatory team is composed of specially trained personnel that work closely with investigators to prepare and maintain IRB documents and requirements and ensure compliance with local and federal regulations. In addition, the regulatory team provides education and consultation to investigators and other study personnel.
- Pre-award financial and administrative services: The pre-award finance team is made up of specialists that can assist in pre-award budget development and negotiation, patient scheduling, visit tracking and other administrative research services.
Accessing CCRO resources
Please contact us at any time to learn more about CCRO services. Below is a summary of the steps involved working with the CCRO. Steps can occur in parallel, and depending on your project requirements, all steps may not apply.
- The CCRO can assist in initiating conversations with sponsors and completing sponsor feasibility questionnaires.
- If applicable, the Office of Research Services (ORS) contracting team will follow-up with the sponsor on a confidentiality disclosure agreement.
- The investigator (and/or member of the study team) completes the Operational Needs Assessment (ONA) in our Children's Research Management System (CRMS) and uses the "Submits to ONA" activity in CRMS to notify the Research Institute and CCRO of a new project/study.
- The CCRO will coordinate a study introductory meeting to go over any questions the investigator has, services required and begin developing a study budget.
- Once initial budget is finalized and approved, the CCRO will initiate discussions and/or negotiations with the sponsor.
- The CCRO will forward applicable agreements to the ORS contracting team.
- The CCRO regulatory specialist will work with the investigator to prepare IRB materials.
- The CCRO clinical research coordinator will work with the CCRO pre-award finance team to prepare Research Service Requests (RSRs) for research ancillary services.
- The CCRO will coordinate the Epic Use Plan meeting to get the study set-up in Epic.
- If appropriate, the CCRO will coordinate a study kick-off meeting, including all ancillary personnel involved with study operations. The CCRO clinical research coordinator will work with the principal investigator to provide training to other CCRO staff as applicable and work with the PI on recruitment and enrollment strategies.
- The CCRO will complete set-up and activation of accounts, including Epic, Kronos and financial account number(s).
- The CCRO clinical research coordinator and investigator will meet regularly to discuss study operations, status and milestones.
CCRO staff will work closely with the investigator and study team to complete and maintain ongoing regulatory requirements, patient visits, documentation and monitor visits in partnership with the Principal Investigator until study closure.
Post-award financial services
General guidance on financial transactions as they relate to all Children's Hospital Colorado Grants
- Grant account setup and closeout
- Monthly, quarterly, and annual grant reports for all Children's housed grants
- Internal and external audit coordination
- Process all general ledger entries on all Children's grants (expense adjustments)
- Review of accounts payable vouchers for all Children's grants and ensure proper coding and status of grants
- Invoicing sponsors for grant payments
- Process patient care chargers in EPIC to General Ledger (charging the grant)
- Coding and processing of grant payments
- Process ad hoc queries of grant activity in PeopleSoft
General contact us: PostAwardAccounting@childrenscolorado.org
Post-award phone number: 720-777-3548
- This number can be used for all inquiries to the Post Award accounting team.
Post-award email: PostAwardAccounting@childrenscolorado.org
- This email address can be used for all inquiries to the Post Award accounting team
- Use this email to update the Owner, Manager and other contacts for your Project. Other information pertaining to your project in PeopleSoft may also be communicated using this email address.
Greenphire@childrenscolorado.org (Patient stipend debit card)
- This email address can be used for all inquiries related to Greenphire.
- Use this email to submit all Greenphire patient forms, new study requests, etc.
- This email address can be used for questions, or submissions related to closing out a project in PeopleSoft.
Updated payment address
Children’s Hospital Colorado
Attn: Grant Cash Management
13123 East 16th Avenue, B148
Aurora, CO 80045
Please feel free to share this updated payment address with your Sponsors, so that checks can be efficiently and accurately processed.