Financial Management of Clinical Research. Office of Research Compliance NSLIJHS 516-562-2018. Overview. In 2007 over $91 million in External Funding was received for Service Delivery and Research projects throughout the Health System
Office of Research Compliance
What is the process in obtaining fund (PeopleSoft #)?
A process for capturing how an individual spends his/her effort over a given time period
Reflected in percentages of total time (100%) worked in the health system regardless of where work is performed
Total includes all effort (hours) spent to meet all commitments to the health system (Total hours will vary from person to person)
Based on actual activities, but may be reasonably estimated
Reported retrospectively or “after-the-fact” every MONTH
Required by federal regulationPost Award Management
Effort is defined as the amount of time spent on a particular activity. Individual effort is expressed as a percentage of the total amount of time spent on work-related activities (clinical care, instruction, research, administration, etc.)
% Effort = Project specific time
All time expended to meet commitments in
the Health SystemHow is effort calculated?
If my department is providing services to a research study what will my
department be reimbursed for those services? If my department is asking another
department to provide services what will we charged?
Outpatient Process for hospital or office based procedures:
When Patient Arrives for Visit (date of service)
Process for Category A subjects (those hospitalized specifically for
Process for Category B subjects (those hospitalized for medical
You should always consult with the appropriate Pharmacy service when evaluating whether to
accept a new study that involves a pharmaceutical agent. Facility Pharmacy Contacts:
Leonard Langino, RPh
Phone: (516) 562-1588 Fax: (516) 562-1697 Email: [email protected]
James Abberton, RPh or Zina Faynblatt, RPhPhone 1: (718) 470-7423 Phone 2: (718) 470-7430 Fax: (718) 343-824 Email: [email protected]
Fax: (718) 343-8244 Email: [email protected]
How do you reimburse the hospital or satellite pharmacies for services provided in
support of clinical research?
If we have a study that covers the cost of a marketed drug that is not provided by the
sponsor, can we buy a supply of the drug through the hospital pharmacy department
from study funds and then dispense it to the subject as we would for any other study?
How would this work?
Managing Per-Diems, Pick-up Hours, and off shift work: CALL Research Compliance before you
consider entering into any of the following. It might be possible but special procedures and in some
cases legal contracts need to be put into place.
For questions or further information, contact particular activity. Individual effort is expressed as a percentage of the total amount of time spent on work-related activities (clinical care, instruction, research, administration, etc.)
Cyndi HahnAdministrator, Research Compliance516-562-2018