PRO Project Intake Process

Researchers who are planning clinical studies that would utilize Pediatric Research Office (PRO) support services should be aware of a revamped intake process at the front end of each study.

PRO provides infrastructure support to clinical research activities of Pediatrics faculty at the UNMC and CHMC, including government- and industry-sponsored studies. PRO staff can provide a variety of services including study planning, budgeting, contracts, regulatory compliance, IRB applications, study coordination, subject recruitment, and data management. The new intake process was designed to assess the level of resources and PRO personnel time each proposed new study will require, while providing transparency in PRO’s process of deciding which projects it is equipped to support.

Prior to a study, the Principal Investigator will complete and submit a two-page PRO Intake Form for review, along with their protocol and proposed budget. If there is not currently funding available for the proposed study, a plan for obtaining funding or a justification for PRO supporting an underfunded project should be provided. PRO will review each project according to the steps diagrammed in the figure below. A PRO staff review group makes the first assessment of general feasibility and resource availability. The CHRI Project Review Committee, consisting of the Scientific Director, Dr. William Rizzo, plus 2-3 additional Pediatrics researchers and the CHRI Research Manager and Finance Analyst, makes the final scientific and feasibility assessment. Their decision will be communicated to the Principle Investigator within 3 weeks of submission of the Intake Form.

“The PRO staff is always happy to answer questions, assist with budgeting, and provide guidance on all research related matters,” states the new policy announcement. “This formal process is solely for the use of retaining PRO resources for a committed period of time on a project.”

PRO Project Intake Process