Clinical and Translational
Research Center

Review Process

To request approval to utilize CTRC resources, an investigator must submit an online application through the appropriate institution's (CHOP or UPENN) electronic protocol submission process. Only one CTRC submission is required, regardless of the location of services requested. However, the application should be submitted to the institution where the majority of the CTRC services are being provided. CTRC Administration staff will share resource information needed between the two programs. 

To submit a proposal via the CHOP CTRC:  The CHOP eCTRC electronic application system is a part of the eResearch/eIRB system for IRB submissions and can be found at eresearch.chop.edu. (Access to the CHOP Intranet is needed).

Once submitted, the CTRC reviews all protocol submissions  The CHOP CTRC holds monthly Resource Committee meetings where all requests for CHOP CTRC resources are reviewed.   The IRBs and CTRCs at both institutions have established a joint scientific protocol review process between the two entities.  Proposals cannot utilize the CTRC until they receive both IRB and CTRC approval.

CTRC will consider emergency protocol approvals under certain circumstances, guidelines are here.

The respective IRBs have also made accommodations for protocols that require services at both institutions. For more information, refer to  IRB SOP 305 on the IRB Policies and Procedures page.

Submission and Review Guidelines for External Institutions using CTRC Services:

PENN (or other external institution) based investigators using CHOP CTRC services

There are two main scenarios that determine the submission process when investigators outside of CHOP request CHOP CTRC Services:

CHOP is not engaged in research (CTRC resources are being purchased and there are no study staff members based at CHOP)

PI/study team must converse with the Core Director and CTRC Administrator and will be asked for the following information in order to consider and approve requests.

  • Contact information of PI and study team. Email address and contact information for billing.
  • Confirm with PENN (other external institution) and CHOP IRBs that CHOP is not engaged in research
  • Electronic copies of the external IRB approval letter, IRB approved protocol and consent.
  • Funding information – grant number(s), award dates
  • Specify test type and quantity of tests for enrolled subjects
  • Provide age information, it is required for reporting to NIH.  

Once the CTRC study is approved, External PI/Study Team will receive:

  • CHOP CTRC will enter the data into eRESEARCH
  • The approval letter listing services and billing details
  • A copy of the CTRC application listing the services
  • Instructions how to schedule subject appointments at the CTRC
  • The External PI/Study Team will be expected to provide annual continuing review  (CR) information such as a progress report, a copy of the IRB CR approval, any revised protocol or consent documents.
CHOP is engaged in research (usually indicated by a CHOP investigator on the project who will have access to data)

PI/Study Team must provide:

  • Contact information of PI and study team. Email address and contact information for billing.
  • You must inform the External and CHOP IRBs that research will be done at CHOP; they will determine if CHOP is engaged in research and if it is a cooperative agreement study. Usually there will be a CHOP Investigator who is involved in reviewing the data. The CHOP Investigator will have to enter the protocol into CHOP’s eRESEARCH system and create the link to the eCTRC module.  PI will have to supply materials such as:
    • Electronic copies of the External IRB approval letter, IRB approved protocol and consent.
    • Funding information – grant number(s), award dates
    • Enrollment information and specify tests required
  • If Penn-based PI:  Will the study use PENN CTRC Services and receive a CTRC review at PENN? A copy of the PENN CTRC review with NIH score will be obtained by CHOP CTRC Administration.

 

Contact CTRC Administrative Staff for assistance:

John Krall, LCSW
Administrative Director, CHOP CTRC
267-425-1790 (office)
267-426-5430 (fax)
krallj [at] email.chop.edu


Sharon Carbonara, RN, BSN
CTRC Protocol Submission Questions:
215-590-0578 (phone)
267-426-5430 (fax)
carbonara [at] email.chop.edu