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:
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:
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.
We strongly encourage investigators to contact the CTSC as early as possible for information about CTSC resources and for assistance in preparing the application.
The input provided by these groups can help to ensure a quick turnaround time in the review of your application.
All applications must be submitted through the electronic Protocol Authoring and Review system (ePAR). To initiate an application, please connect to:
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 Juan Cordero, MD (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 firstname.lastname@example.org.
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.
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:
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:
Please contact Pankaj Patel (646-962-8154) with any questions about patient care-related budgeting or the information below.
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:
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.
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.
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.