Chesapeake IRB Process Flow for Industry Sponsored Phase I- IV Studies
The UH Clinical Research Center has engaged Chesapeake IRB to serve as the IRB of record for University Hospitals industry sponsored Phase I-IV protocols. University Hospitals Cleveland Medical Center IRB and Chesapeake IRB have executed an IRB Authorization Agreement. UH IRB Chairs and Leadership may determine that certain Phase I studies are not appropriate for review by Chesapeake and should be discussed with Carol Fedor at Carol.Fedor@UHHospitals.org.
UH Cleveland Medical Center investigators must receive approval from the industry sponsor to the use and pay all additional associated fees for the use of Chesapeake IRB. Research personnel will submit research projects directly to the Chesapeake IRB via their electronic system, Center for IRB Intelligence (CIRBI). The consent template has been vetted between UH Cleveland Medical Center and Chesapeake IRB to meet UH Cleveland Medical Center IRB requirements.
The designated project team member from Chesapeake IRB will communicate directly with the Principal Investigator (PI) and designated research staff regarding the conduct of research under Chesapeake IRB’s purview. The PI (or designated research staff) will work directly with the designated project team member from Chesapeake IRB to address any study-related issues throughout the conduct of the research (i.e. from study start to termination). Chesapeake IRB fees will be negotiated between Chesapeake IRB and the Sponsor.
Prior to conducting any study-related activities, the Principal Investigator and research staff should read all approval letters, as well as become familiar with the most current version of the Chesapeake IRB Investigator Handbook, accessible via CIRBI, to ensure compliance with Chesapeake IRB’s requirements, expectations, and approval.
Chesapeake IRB will grant access to the CIRBI system to IRB Administrators at UH Cleveland Medical Center to ensure local control of research activities taking place at UH Cleveland Medical Center.
If additional help is needed, contact Carol Fedor, RN, ND, CCRC Director, Human Research Protection Program at 216-844-5524 or Carol.Fedor@Uhhospitals.org.