Expedited Applications

Externally Peer-Reviewed and Approved Studies

A shortened application with expedited scientific review is available for studies that are requesting research patient-related services, but have already been approved through an external peer-review process, such as competitive peer-review for a grant from a federal or private foundation funding source. This option is appropriate for peer-reviewed and approved studies requesting any of the following services from the CTSC:

• Inpatient/Outpatient Units
• Nutrition Research and Services
• Research Ancillary Support 

Core-Only Application

A shortened application with expedited scientific review is available for IRB- or IACUC-approved (as appropriate) studies requesting access to any combination of the following resources:

• CTSC General Core Laboratory
• CTSC Molecular Core

Note that studies requesting any of the above resources IN COMBINATION WITH patient care-related resources (inpatient/outpatient units, nutrition services, and/or research ancillary support) must use, depending on the case, either the Full Resource Application or the Expedited Application for Externally Peer-Reviewed and Approved Studies.

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 would like to use CTSC data management resources (REDCap) please contact Jessie Lee (Research Data Management Project Manager) prior to submitting your application.
• Prior to application submission, please contact Pankaj Patel, Research Manager (646-962-8154), to discuss the specifics of your requests for patient care resources. Please see Appendix I, later in this document, for important details regarding CTSC budget preparation.

The input provided by these groups can help to ensure a quick turnaround time in the review of your application. 

The Application Process

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. When asked, indicate that the study has already been reviewed and approved by an external peer review process. 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 "Run Completeness Check" 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 Michael Bales (Protocol Review & Regulatory Manager) if you have any questions about the messages returned by the Completeness Check routine. If you experience any problems the electronic system or have suggestions for improvements, please contact Elizabeth Wood, Director of the Core Informatics Group, at eawood@med.cornell.edu.

When your application is complete (or appropriate waivers have been granted by the Protocol Review Coordinator), you may submit it by clicking the "Submit" link on the Application Status Page.

The Review Process

Shortly after you submit your application, it will be scheduled for review. You can view your application's status at any time by logging in to ePAR. The review will proceed as follows:

• Your application undergoes administrative review for completeness of fields and mandatory documents
• The application is sent for review of requested resources by the appropriate Core Director(s)
• The application is routed for review of requested resources to:
  • Scientific Reviewer
  • Research Subject Advocate (if requested by the Scientific Reviewer)
  • Biostatistician (if requested by the Scientific Reviewer)
• 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 response or revision
  • Deferred

For Expedited Applications associated with externally peer-reviewed and approved studies allow about five business days for approval of your requested services and about five business days for scientific review. After this time, you will hear from the Protocol Review Coordinator regarding the outcome of the review:

• If there are questions, they will be sent to you for response
• If there are no questions, you will receive notification of approval and a message to contact appropriate CTSC personnel who can help you get started with accessing resources.
• Once the protocol is approved, IRB or IACUC application and approval letters must be submitted via ePAR before CTSC resources can be accessed. If there were not included in the initial submission.

Appendix I: Protocol Budgets and Funding

Please contact Pankaj Patel (646-962-8154) with any questions about patient care-related budgeting or the information below.

Funding Categories

The extent to which the CTSC funds the costs for hospitalization and ancillary tests performed on research subjects depends upon the type of research being performed and the available patient care funds awarded through the CTSC grant.

The CTSC defines inpatient and outpatient research subjects as follows:

• Category A: Inpatient admissions or outpatient visits, solely for research purposes where hospitalization would otherwise be unnecessary and no health advantages are expected to accrue as a result of the hospitalization or visit. The CTSC pays for hospitalization (bed costs), and/or outpatient visits and research costs itemized on the approved version of the protocol budget. This also applies to protocols that are investigator-initiated, even if industry has agreed to provide funding (documentation required).
• Category B: Patients in the hospital for treatment of a disease or disorder may also be part of a research study. Costs for diagnosis and treatment according to established standards of care are billed to the patient or third-party coverage. Certain ancillary costs related to research may be covered by the CTSC.
• Category D: Industry-initiated research. All charges are paid directly by industry through the responsible investigator. The investigator should contact the Administrative Manager, Pankaj Patel at 646-962-9154 for current charges.
• Mixed A and B: Patients under standard care may have "study category A days" devoted primarily to research. The CTSC grant pays for the routine hospitalization costs for those days, in addition to other specific ancillary charges agreed upon during the review process.
• Scatter-bed: Occasionally research costs for scatter-beds (non-CTSC beds) may be charged to the CTSC grant when special facilities (e.g., intensive care unit or other services requiring unique resources not available on the CTSC), are required to accommodate a research patient. Scatter-bed requirements are determined on an individual project basis.
• Offsite Research Visit (ORV): When required, subjects may be seen in facilities that are neither JCAHO-accredited nor Medicare- or Medicaid- certified (e.g., school, church, clinic). Please contact the CTSC for more information if your study will have these types of visits.

The grant covers the costs of the research on category "A" and "B" patients. It also covers the cost of hospitalization for category "A" subjects. It does not cover the cost of non-research tests, which may be performed coincidentally or as a convenience to the subject. The grant also does not cover the cost of the hospital room and medical care for type "B" or "D" patients.

Research and Hospitalization Costs

It is the responsibility of the principal investigator to explain to subjects the hospitalization costs of their participation in the study and the assumption of the responsibility for those costs by either the CTSC, the investigator's own funds, third-party payers, or the individual study subject. It is the investigator's responsibility to make certain that participants understand that only the research costs for time spent on the CTSC may be paid by the center, and that the CTSC is not responsible for charges that apply for any other purpose or period of their hospitalization.

Ancillary Tests and Procedures

The CTSC offers many services at minimal or no charge for protocols that are investigator initiated (e.g. patient meals, nursing services, specialized core lab assays, biostatistics and informatics support).

In addition to these services, the CTSC has a limited amount of funding to assist investigators in conducting their studies. These ancillary funds may be used to pay for additional items detailed on the protocol budget approved by the Translational Research Advisory Committee. Ancillary services are defined as services routinely available through the hospital departments for all patients in the hospital (e.g., blood tests, x-rays, medications). This definition may apply even when these services are purchased from sources outside the hospital for reasons of economy or efficiency. The CTSC, however, cannot assume the responsibility for high cost ancillary services such as CT scans, MRIs, etc., unless approved in advance by the Advisory Committee. For a list of available labs and costs, refer to the NYPH Lab Fee Schedule.

Other Requirements

• All industry-initiated or industry-sponsored protocols must include a copy of the signed and approved contract in ePAR.
• Protocols with external funding (NIH, foundation, or institutional) must also submit a copy of the budget submitted with the grant proposal.