NEXT Research Registration Tutorial 1 Yale Medical Group Research Registration Tutorial November 30, 2010

NEXT Research Registration Tutorial 2 It is the Yale Medical Group’s (YMG) goal to register research studies and the patients enrolled in studies in the GE/IDX system. It is the Yale Medical Group’s (YMG) goal to register research studies and the patients enrolled in studies in the GE/IDX system. This first step will enable us to bill clinical care services provided to our patients who are enrolled in clinical research studies correctly. Medicare, Medicaid and the private insurance companies have special billing rules for their insured members who are enrolled in human subject clinical research studies. Clinical care services in research studies may be: This first step will enable us to bill clinical care services provided to our patients who are enrolled in clinical research studies correctly. Medicare, Medicaid and the private insurance companies have special billing rules for their insured members who are enrolled in human subject clinical research studies. Clinical care services in research studies may be: 100% funded by a sponsor, 100% funded by a sponsor, partially funded by a sponsor, or partially funded by a sponsor, or unfunded and/or non-sponsored. unfunded and/or non-sponsored.

NEXT Research Registration Tutorial 3 Therefore, in our ongoing efforts to bill for clinical care services correctly and in concert with our Medical Billing Compliance Program, we are initiating a process to register patients in human subject research studies in our GE/IDX billing system. Therefore, in our ongoing efforts to bill for clinical care services correctly and in concert with our Medical Billing Compliance Program, we are initiating a process to register patients in human subject research studies in our GE/IDX billing system. This tutorial will introduce you to the two new forms that will be required before a research study is approved. These forms are effective only for research studies approved by the IRB on or after Nov 1, 2007'. This tutorial will introduce you to the two new forms that will be required before a research study is approved. These forms are effective only for research studies approved by the IRB on or after Nov 1, 2007'.

NEXT Research Registration Tutorial 4 Non-compliance with Human Subject Protection billing rules may expose our institution, Principal Investigators and other research personnel to fines and also prohibit them from participation in research activities. Non-compliance with Human Subject Protection billing rules may expose our institution, Principal Investigators and other research personnel to fines and also prohibit them from participation in research activities. By registering all studies and patients enrolled in the studies in the GE / IDX billing system, our practice will be better able to manage our billing compliance. By registering all studies and patients enrolled in the studies in the GE / IDX billing system, our practice will be better able to manage our billing compliance. The institutions listed next are just a few of the institutions that have paid fines as a result of research related enforcement activity. The institutions listed next are just a few of the institutions that have paid fines as a result of research related enforcement activity.

NEXT Research Registration Tutorial 5 Rush University$1,000,000 UCONN$2,500,000 Beth Israel Deaconess$920,000 Medical College of Georgia$6,100,000 New York University$15,500,000 Thomas Jefferson University$2,600,000 University of California San Diego$4,700,000 University of California$625,000 University of Chicago$650,000 ($400k from PI) University of Minnesota$32,000,000 University of Utah$950,000

NEXT Research Registration Tutorial 6 “Request to Create a New Clinical Study in GE/IDX” Form FM.A This form will be required whenever a new human subject research study involving billable clinical care services is opened. These studies will be identified when the PI responds to the following new question listed on the HIC Application for a new research project. “Will your research study require rendering clinical care services to human subjects that may be billable to the subject, the sponsor or other third party payer?” If “yes”, please complete the “Request to Create a New Clinical Research Study” form at: FM.A_NewStudyRequest%20rev% _tcm pdf FM.A_NewStudyRequest%20rev% _tcm pdf The clinical department is responsible for completing Section I and Section II on the form and faxing, ing or filling out the form online and sending it to Manager, Awards Set-Up Unit at Fax #

NEXT Research Registration Tutorial 7 “Request to Create a New or Re- Approved Clinical Study in GE/IDX” Form FM.A Section I of III Official Study Name – The official name that the sponsor assigns to the study. Is this a: New Study or Re-Approved Study Indicate if this is a NEW or Reapproved Study

NEXT Research Registration Tutorial 8 Abbreviated Study Name – Since many studies have very long names, please provide the abbreviated name if relevant. “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section I of III

NEXT Research Registration Tutorial 9 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section I of III Sponsor Protocol number – This is the number that the Sponsor has assigned to the study.

NEXT Research Registration Tutorial 10 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section I of III HIC # - Human Investigation Committee approval number (if known).

NEXT Research Registration Tutorial 11 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section I of III HIC Approval Date – This is the date that the HIC approved the study (if known).

NEXT Research Registration Tutorial 12 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section I of III IDE # - Investigational Device Exemption number if applicable.

NEXT Research Registration Tutorial 13 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section I of III IND # - Investigational Drug number if applicable.

NEXT Research Registration Tutorial 14 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section I of III Principal Investigator – First and last name of the lead Principal Investigator for the study.

NEXT Research Registration Tutorial 15 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section I of III PI’s Department – The clinical department that is sponsoring the study.

NEXT Research Registration Tutorial 16 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section I of III PI’s Phone – Phone number for the Principal Investigator.

NEXT Research Registration Tutorial 17 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section I of III Secondary Contact Name – First and last name of a contact familiar with the study and who can answer questions regarding routine services versus research only clinical services. A likely candidate may be an individual from the business office who assisted with the budget development.

NEXT Research Registration Tutorial 18 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section I of III Secondary Phone – Phone number for the secondary contact.

NEXT Research Registration Tutorial 19 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section I of III and Office Address for the secondary contact. Address Office Address

NEXT Research Registration Tutorial 20 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section II of III Is this a Medicare qualifying research study? To determine Medicare coverage status, f ill out the Qualifying Study Checklist located at :

NEXT Research Registration Tutorial 21 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section II of III Medicare has certain criteria that need to be met before they will pay for routine care services in a research study. A Medicare qualifying checklist is available on the Compliance website to help researchers determine whether a study qualifies for Medicare reimbursement.

NEXT Research Registration Tutorial 22 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section I of III

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NEXT Research Registration Tutorial 25 Signature of person completing this form Sign:_________________________Date: ______________

NEXT Research Registration Tutorial 26 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section II of III Does this study require a PTAEO? PTAEO # - The number the University assigns to the research study account. Professional services reimbursed by the sponsor get billed to the PTAEO #.

NEXT Research Registration Tutorial 27 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section II of III Does this study require a YNHH T-Account number? T- Account # -The financial accounting number assigned by YNHH to the research study and used for billing technical charges back to the PTAEO.

NEXT Research Registration Tutorial 28 Services are 100% standard of care, billable to the patient’s insurance. Check this box if the study is a qualifying Medicare study or will receive pre-authorization from private insurance companies and all services are standard of care. “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section II of III

NEXT Research Registration Tutorial 29 Services are 100% Sponsor Paid nothing billable to the patient’s medical insurance – Check this box where the sponsor is reimbursing all costs associated with the study. “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section II of III

NEXT Research Registration Tutorial 30 Services are a mixture of Standard of Care and Sponsor Paid. Check this box if the study is a qualifying Medicare study or will receive pre-authorization from private insurance companies and some services are paid by the sponsor (example Study Drug) and other clinical care services qualify for insurer reimbursement. “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section II of III

NEXT Research Registration Tutorial 31 “Request to Create a New Clinical Study in GE/IDX” Form FM.A Section III– To be completed by YSM Financial Business Office Contract approval date – The date the research contract was approved by Grants and Contracts. PTAEO # - The number the University assigns to the research study account. Professional services reimbursed by the sponsor get billed to the PTAEO #. YNHH T-account – The financial accounting number assigned by YNHH to the research study and used for billing technical charges back to the PTAEO.

NEXT Research Registration Tutorial 32 “Request to Create a New or Re-Approved Clinical Study in GE/IDX” Form FM.A Section III The Director of Business Services is responsible for filling out Section III and sending the completed form to Patient Financial Services at You can find a PDF copy of this form to print out at this URL: Scroll down to form F.M.A If this is a NEW study, a copy should also be sent to:

NEXT Research Registration Tutorial 33 Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX FM.B This form will be required whenever a patient is enrolled or Terminated/Completed in a human subject research study involving billable clinical care services. The clinical department is responsible for filling out this form and faxing, ing or filling out the form online and sending it to the Case Manager in Patient Financial Services. The user may want to retain a copy of the form in the patient file when adding a patient so that when the patient is Terminated/completed, most of the information required is already on the form.

NEXT Research Registration Tutorial 34 Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX FM.B Section I of II Abbreviated Study Name - Since many studies have very long names, please provide the abbreviated name if relevant. If there is no abbreviated name, enter the official name of the study.

NEXT Research Registration Tutorial 35 Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX FM.B Section I of II HIC # - Human Investigation Committee approval number.

NEXT Research Registration Tutorial 36 Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX FM.B Section I of II Contact’s Name – Employee’s first and last name designated by the clinical department to enroll, Term/Complete patients.

NEXT Research Registration Tutorial 37 Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX FM.B Section I of II Contact’s Phone - Employee’s phone number designated by the clinical department to enroll, Term/Complete patients.

NEXT Research Registration Tutorial 38 Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX FM.B Section I of II Contacts - Employee’s designated by the clinical department to enroll, Term/Complete patients.

NEXT Research Registration Tutorial 39 Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX FM.B Section II Patient Name: First and last name of the subject who is being enrolled, Term/completed or who was a screening failure. MRN # - Yale Medical Group Medical Record Number.

NEXT Research Registration Tutorial 40 Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX FM.B Section II Enroll – Check if enrolling a patient. Terminated / completed – Check if terminating or completing a patient. Not eligible-ex: (screen failure ) Check if the patient did not meet the eligibility criteria.

NEXT Research Registration Tutorial 41 Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX FM.B Section II Start Date – Only use for Not eligible ‘screening failures’. Indicate the date the subject initially started going through the eligibility process. End Date: Only use for Not eligible ‘screening failures’. Indicate the date the subject was classified as ‘ineligible’ for participation in the study.

NEXT Research Registration Tutorial 42 Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX FM.B Section II Effective date – the date the patient was enrolled in a research study. End Date – the date the patient was Terminated/completed in a research study.

NEXT Research Registration Tutorial FM.B Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX How to Submit This Form A PDF Version of this form can be printed, saved and ed as an attachment to:

NEXT Research Registration Tutorial 44 You can find a PDF copy of this form to print out at this URL: Scroll down to form F.M.B

NEXT Research Registration Tutorial 45 How to receive credit for this tutorial If you have accessed this presentation through the TMS training page located at scroll down in that window, there is an “I agree” button to select and submit the page for credit. If not, use the attestation at the link on the next page

NEXT Research Registration Tutorial 46 To print off a paper copy of the attestation, To fill out and submit attestation by , Another way is to use the attestation, print it off and fax or mail it to the Compliance Department: Attention: Tony Fusco at Thank you for completing this training!