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Applying to Use CTSC Resources

Before You Apply
The Application Process
The Review Process
Submitting an Amendment
Appendix: Short Form for Core Use-Only Applications
Appendix: Short Form for Externally Reviewed and Approved Studies

Overview and Scope

The current document describes the application and review process for research protocols requesting the use of CTSC resources such as its inpatient and outpatient facilities, nursing care, core laboratory, nutrition services, or data management resources. If you are applying for a CTSC award (pilot, planning, KL2, TL1, community, novel, or other awards announced through specific RFAs from the CTSC) or to the CTSC’s K30 program (certificate or Master’s degree in Clinical Research), please see the applicable RFA for information on how to apply.

Applications for use of CTSC resources (i.e., applications to which the current document applies) fall into three categories:

Core Use-Only application. An application will be categorized as “core use-only” if its requests for CTSC resources are limited to biostatistics, research data management services (REDCap), the CTSC General Core Laboratory, and/or the CTSC Molecular Core, or any combination of these resources. (Please note that this list of cores eligible for the core-only application is subject to change; additional cores may be added in the future.). Core Use-Only applications benefit from a significantly simplified application form and an expedited review process. Please note that core use-only applications involving human subjects MUST HAVE IRB approval prior to submission; similarly, those applications involving animal subjects must have IACUC approval prior to submission. Click here for a full description of the short form review process.
Externally Reviewed and Approved study. If an application does not meet the criteria for “core use-only” but the study has been approved through an external peer review process (recognized panel of faculty/scientists who are experts in the same field; e.g., NIH, DOD, foundation) then it is eligible to use the “Externally Reviewed and Approved” short application form. Like core use only applications, externally reviewed and approved studies have fewer application requirements and an expedited review process compared to studies that have not had prior external peer review. Click here for a full description of the externally reviewed study review process.
CTSC-Reviewed Full Research Application. Applications for CTSC resources that do not meet the criteria for “Core Use-Only” or “Externally Peer-Reviewed and Approved” must go through a full scientific review by the CTSC’s Translational Research Advisory Committee (TRAC; see description later in this document). The application requirements are somewhat greater for these applications in order to ensure complete and unambiguous information for the scientific reviewers.

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Before You Apply

We strongly encourage investigators to contact the CTSC as early as possible for information about CTSC resources and for assistance in preparing the application.

Our Translational Research Support Team (TREST) can provide personalized assistance throughout the application process.
Consult with the CTSC biostatistician before finalizing your research plan.
If your study is requesting use of CTSC data management resources (REDCap) please contact Jessie Lee (Research Data Management Project Manager) prior to submitting your application.
If your protocol is industry-initiated, you must contact Dilcia Grenald before initiating your protocol application.
As noted above, Core Use-Only applications must have IRB and/or IACUC approval (if applicable) prior to submission.

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The Application Process

Many details are involved in preparing and submitting a protocol to the CTSC. This section will assist you in getting started. Make sure to read and follow all the instructions. Incomplete information can delay review of your protocol.

All applications must be submitted through the electronic Protocol Authoring and Review system (ePAR). To initiate an application, please connect to:

ctsc.med.cornell.edu/apply

You will be asked to answer a small set of basic questions about your planned study, including PI name, study title, and resources you are requesting from the CTSC. Once this information has been submitted, your new application (including user ID/password if you are a new user) will be enabled within several business hours. You will be notified by e-mail when this process is complete, and you can then log in to the system to complete and submit your application.

After all sections of the application have been completed, you should click the red "Check Application for Completeness" link in the electronic system. Certain types of incomplete information will prevent you from submitting your protocol (shaded in yellow or beige); others will only generate warning messages. Please contact Kaarel Laev (Protocol Review Coordinator) if you have any questions about the messages returned by the Check Completeness routine. If you experience any problems USING the electronic system or have suggestions for how it can be improved in the future, please use the “Contact Us” link within ePAR to log your problem reports or suggestions at the WebCAMP issue tracker.

Budgets: Basic information on budgets can be found in the Application Process => Budgets and Funding section of the current Web site. If you have any questions about your protocol budget, please contact Dilcia Grenald, Administrative Manager for the CTSC's Clinical and Translational Resource Unit.

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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). In addition, studies involving human subjects and wishing to utilize the “Core Use-Only” short application form must have IRB approval prior to submission of the application in ePAR; similarly, studies involving animal subjects and wishing to use the Core Use-Only short form must have prior IACUC approval prior to ePAR application submission. For questions about the review process, please contact Kaarel Laev, Protocol Review Coordinator (email: KTL2001@med.cornell.edu , phone: 646-962-8156).

Translational Research Advisory Committee (TRAC)
Once your application for use of CTSC resources is completed and all required documents have been uploaded, the application is sent for scientific review and scheduled for the next available TRAC review meeting. (Note that Core Use-Only and Externally Reviewed and Approved applications will normally be reviewed independently of meetings to expedite the review process.)

Faculty from Weill Cornell Medical College 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.

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. These are detailed in the letter of approval.

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Instructions for Submitting Amendments in ePAR

ALL protocol revisions require approval by the CTSC Translational Research Advisory Committee (TRAC) before changes can be implemented on the CTSC. Any change submitted to the IRB must also be submitted to the CTSC.

To update your protocol in ePAR, on the lower left of the Summary page, click on “amend current protocol,” and proceed as follows:

In the appendices section under “other attachments”, upload a memo to the TRAC that includes:
1. A list of revisions
2. Justification for the revision(s)
3. Which documents were revised
4. Page in the narrative, or section in which revision appears
All documents that have been modified must have changes highlighted
If a revision requires change(s) to the consent form(s) or methodology, approval from the IRB is also required before the protocol can proceed.
Submission deadlines for amendments are the same as for a new protocol – 2 weeks prior to the monthly TRAC meeting.

Please Note:

Any changes to the protocol must also be reflected in the study plan and budget.
The CTSC's budget is dependent on year-to-year support granted by Congress through the NIH. Our support of this study beyond the current calendar year is dependent on continued federal support to our facility.

Expedited approval may be requested for minor changes to a protocol that do not add cost or make significant changes to the methodology.

You MUST contact the Protocol Coordinator for information on revisions that meet the criteria for expedited approval PRIOR to submitting the amendment.

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Appendix I:
Short Form for Core Services Only Requests

A briefer form is now available in ePAR for studies requesting the following CTSC Core Services only:

General Core Lab
Molecular Core
Biostatistics Core
Research Data Management (REDcap)

REQUIREMENTS

Before Submission, PI should contact appropriate CORE DIRECTOR(S)
The Protocol must already have current IRB or IACUC approval

SUBMISSION

Core Use-Only applications use the same initiation process as other applications for CTSC resources. To initiate an application, connect to ctsc.med.cornell.edu/apply and answer a few short questions. Your application (as well as username/password if you are new to ePAR) will be enabled within several business hours and you will be notified when you can log in to complete your application.
The following ePAR section and documents are required:
- Summary Page
- Resources Requested
- Biosketches/ Other Support for PI and Key Personnel
- Supporting Documents – uploaded as PDF:
  - IRB or IACUC application
  - IRB or IACUC approval letter
  - HIPAA form (if applicable)
Submit protocol

REVIEW PROCESS

You will receive an email that the review process has been initiated
Your protocol undergoes administrative review for completeness of fields and mandatory documents.
Protocol is sent for review to:
- Appropriate Core Director(s)
- CTRU Administration
Reviewers consider feasibility of the request, including resources required and costs associated with project and include any issues or concerns in their reviews
Reviewer submits review in ePAR and enters recommendation:
- Approved
- Approved pending revision
- Deferred

NOTIFICATION OF REVIEWS AND QUESTIONS OR APPROVAL

If there are questions, they will be sent to you for response within 5 business days
If there are no questions, you will receive notification of approval and a message to contact Lily Suh, TREST Manager to initiate the protocol.

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Appendix II:
Short Form for Externally Reviewed and Approved Studies

This ePAR application form is for studies that have been reviewed, approved, and funded by an external scientific/ advisory body.

REQUIREMENTS

Proposals must already have approval by an external scientific/ advisory body. Examples include NIH, DOD, or foundation.

CONSULTATION

Before submission, the PI should contact the Director of any core or area from which services are being requested.