Protocol Submission and Review Process

Applying To Use the CTSC:

We strongly encourage investigators to contact the CTSC as early as possible for information about CTSC resources and for assistance in preparing the application. Before submitting an application to use the CTSC, investigators must contact: Rita Falbel, Protocol Review Coordinator 212-746-6291 rfalbel@med.cornell.edu

It is strongly recommended to consult with the CTSC biostatistician before finalizing your research plan.

Many details are involved in preparing and submitting a protocol to the CTSC. The links in this section will assist you with the forms and instructions. Make sure to read and follow all the instructions.
Incomplete information will only delay review of your protocol.

All applications must be submitted through the electronic Protocol and Review (ePAR) system.

To obtain a user ID and temporary password for access to the system, go to: CTSC ePAR SYSTEM

All sections must be completed prior to submitting the protocol for review by the Translational Research Advisory Committee (TRAC). Do not forget the following:

• Data and Safety Monitoring Plan (refer to our Risk Assessment Guidelines regarding risk categories)
• IRB consent form (Draft copies are acceptable during initial submission; however, an approved WMC consent form is required prior to study initiation on the CTSC.)
• Targeted Enrollment Form
• Biosketch and Other Support in PHS398 format
• Grant application, budget, and pink sheets (if NIH supported)
• Industry Contract (if applicable)

Contact the following CTSC staff members prior to submitting your protocol:

1. Rita Falbel, Protocol Coordinator – Ms. Falbel will review with you details of the application submission and approval process as well as the CTSC ePAR system.
   
   
2. Dilcia Grenald, Asst. Administrative Manager – Preparing an accurate and complete CTSC budget is a critical aspect of the application. Ms. Grenald will review CTSC funding policies and assist you with developing a protocol budget. The extent to which the CTSC provides funding for protocols depends upon the type of research being performed. For detailed information, refer to Budgets and Funding.
   

The Review Process:

Before patients may be studied at the CTSC, a project proposal must be submitted and approved by two committees, the CTSC Translational Research Advisory Committee (TRAC) and an Institutional Review Board for Human Rights in Research (IRB).

Translational Research Advisory Committee (TRAC): Faculty from WMC and partnering institutions representing a diversity of medical disciplines sit on this committee. They meet regularly and review each project proposal primarily for scientific merit, the need for CTSC resources, and the amount of research support requested.

PIs are welcome to attend the portion of the meeting during which their application is discussed. Please contact the Protocol Coordinator in advance if you would like to attend. After the review, the TRAC may suggest changes that need to be made to the study before it can be approved. When you receive your review, please contact us if you have any questions or concerns.

Once the CTSC web-based application is completed and all documents are uploaded, the application is sent for scientific review and scheduled for the next available TRAC review meeting.

Upon Approval

Please note that TRAC approval of a CTSC application comes with several responsibilities as directed by our funding agency, the National Center for Research Resources (NCRR) at the NIH.

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