The Full Resource Application is available for studies that have not already been approved by an external peer review process and wish to utilize research patient-related services including:
- Inpatient/Outpatient Units
- Nutrition Research and Services
- Research Ancillary Support
These applications can also include requests for additional CTSC resources such as Research Data Management, Biostatistics and Core Laboratory Services, but are distinguished from the expedited short form application options by the absence of prior peer review and approval and the need to utilize the research patient services listed above.
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, Associate Director, Center Operations (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. 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 Pankaj Patel (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 how it can be improved in the future, please contact Elizabeth Wood, Director of the Core Informatics Group, at eawood@med.cornell.edu.
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). For questions about the review process, please contact Pankaj Patel (Protocol Review & Regulatory Manager).
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.
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 Pankaj Patel (Protocol Review & Regulatory Manager) 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.
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 646-962-8154 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.