FAQs
Q: I am doing clinical research, what form do I need to fill out?
A: The Human Research Billing Compliance Analysis form, (HRBAF) is required for all clinical research studies that have to be approved by the IRB. For studies where patient medical services are being rendered, the HRBAF is used to determine the billing disposition for the patient service activity in regards to protocol. Prior to filling out the form one must determine what patient care services on the protocol are Standard of Care vs. strictly research, and whether the service is billable to the patient, his/her insurance, or to the study account. An incidental benefit of completing the HRBAF according to many investigators is that the analysis of how the clinical services will be billed is very helpful when preparing the study budget.
Q: My research does not involve the rendering of patient care services and there will be no billing involved. Do I need to fill out the HRBAF?
A:
Yes. There is a section on the HRBAF that pertains to such studies. Some examples of such studies include patient registries, retrospective data review and studies that involve the analysis of waste tissue.
Q: I don't understand the HRBAF; where can I get help filling it out?
A:
Step-by-step instructions for completing the HRBAF can be found on the intranet. Additional assistance with the HRBAF, can be obtained from your department compliance liaison. For a directory of WCMC's department compliance liaisons click here: http://intranet.med.cornell.edu/billingcompliance/pdf/2_2_dep_com_sta.pdf. Prior to submission to the IRB the form must be verified and signed by the PI, Department Chair/Administrator and your compliance liaison leader in your department.
Q: When do I need to submit the HRBAF?
A: A HRBAF is required for all clinical research at the time of IRB submission, for new studies, continuing review, expedited reviews and when there are amendments to the protocol.
Q: My study is up for continuing IRB review and I already submitted the HRBAF. Do I have to re-submit the form?
A: Yes. An updated HRBAF must be submitted for continuing review. If there have been no changes to the study, submit a copy of the previous form and indicate in the areas specified that there have been no changes to the protocol. If changes were made to the protocol, you can fill out a new form highlighting the changes, or work from a copy of the previously submitted form to indicate changes. Approval signatures are required again.
Q: I have a new industry sponsored clinical trial. How do I get started?
A: Contact the Office of Clinical Trials Administration (OCTA) at 212-746-3774. At this time it is recommended that you request a feasibility meeting in which your study team, along with the OCTA staff, will conduct a comprehensive analysis of the sponsor's proposal therefore determining the viability of the study. If the sponsor has sent you a CDA please promptly forward this document to the specialist.
Q: When does the Institutional IRB fee apply?
A: This one time fee applies to industry sponsored clinical trial studies that have gone through a full board review. All contracts received by 5pm Friday, June 29th will be charged the IRB fee of $1,500. Thereafter contracts will reflect the IRB fee increase to $2,000.
Q: How do I receive my study funds from the sponsor?
A: The Office of Clinical Trials Administration (OCTA) will invoice the sponsor for the $2000 IRB fee, along with the study start up fees, upon execution of the clinical trial agreement. For the duration of the study, the PI/Department is responsible for invoicing the sponsor according to the payment schedule in the clinical trial agreement. The Sponsor checks are sent directly to OCTA where they are deposited in the appropriate account. The appropriate persons are copied.
Q: My study's sponsor won't pay our indirect cost rate of 33%. Can this rate be reduced for my study?
A: Our indirect cost rate of 33% is set by our board of trustees.
Q: Does the indirect cost rate of 33% apply to all costs that we invoice the sponsor?
A: This rate is applied to all direct costs associated with clinical trials, the exceptions being the $2,000 Institutional IRB review fee and any applicable pass through fees, such as advertising expenses.
Q: Why should I use the Research Pharmacy for my study?
A: The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requires that the administration of investigational drugs be under the central control of the New York Presbyterian Hospital Investigational Pharmacy. Contact the Department of Pharmacy, Investigational Drug Service at 212-746-0743 for additional information.
Q: How do I obtain an FRS account number for my industry sponsored clinical trial study?
A:
The Office of Clinical Trials Administration will automatically request a new FRS account number for every study upon execution of the clinical trial agreement which includes a receipt and approval of the completed HRBAF
Q: What is an Eagle Billing Plan code and how do I obtain one?
A: The Eagle Billing Plan code is a number used by the NYPH to bill research related services to the investigator's grant. It is the hospital equivalent to the FRS account when there are patient services rendered. Using the Human Research Billing Analysis Form (HRBAF), the Office of Clinical Trials Administration will obtain a Plan code for every account that requires one.
Q: There are research-related hospital services on my study. How do I obtain the fees for those procedures?
A: The NYPH Research Fee Schedule is available at http://intranet.med.cornell.edu/billingcompliance/pdf/NYWC_Charge_Master.XLS (intranet only). IF you need assistance, contact NYPH at 212-585-6421.
