Yale Medical Group Research Registration Tutorial

1. Yale Medical Group Research Registration Tutorial October 11, 2007

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. • 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, • partially funded by a sponsor, or • unfunded and/or non-sponsored.

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. • 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'.

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. • 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.

6. “Request to Create a New Clinical Study in GE/IDX”Form 11100.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: http://www.yalemedicalgroup.org/pfs/forms/10000/NewStudyRequest.pdf The clinical department is responsible for completing Section I and Section II on the form and faxing, emailing or filling out the form online and sending it to Manager, Awards Set-Up Unit at ASU@yale.eduFax # 785-4169

7. Official Study Name – The official name that the sponsor assigns to the study. “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section I of III

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 11100.FM.A Section I of III

9. Sponsor Protocol number – This is the number that the Sponsor has assigned to the study. “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section I of III

10. HIC # - Human Investigation Committee approval number (if known). “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section I of III

11. HIC Approval Date – This is the date that the HIC approved the study (if known). “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section I of III

12. IDE # - Investigational Device Exemption number if applicable. “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section I of III

13. IND # - Investigational Drug number if applicable. “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section I of III

14. Principal Investigator – First and last name of the lead Principal Investigator for the study. “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section I of III

15. PI’s Department – The clinical department that is sponsoring the study. “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section I of III

16. PI’s Phone – Phone number for the Principal Investigator. “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section I of III

17. 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. “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section I of III

18. Secondary Phone – Phone number for the secondary contact. “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section I of III

19. Email and Office Address for the secondary contact. “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section I of III Email Address Office Address

20. “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section II of III Is this a Medicare qualifying research study? To determine Medicare coverage status, fill out the Qualifying Study Checklist located at :http://yalemedicalgroup.org/comply/alert/ctworksheet1.html

21. “Request to Create a New Clinical Study in GE/IDX”Form 11100.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. http://yalemedicalgroup.org/comply/alert/ctworksheet1.html

22. “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section I of III

25. Signature of person completing this form Sign:_________________________Date: ______________

26. PTAEO # - The number the University assigns to the research study account. Professional services reimbursed by the sponsor get billed to the PTAEO #. “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section II of III Does this study require a PTAEO?

27. T- Account # -The financial accounting number assigned by YNHH to the research study and used for billing technical charges back to the PTAEO. “Request to Create a New Clinical Study in GE/IDX”Form 11100.FM.A Section II of III Does this study require a YNHH T-Account number?

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 11100.FM.A Section II of III

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 11100.FM.A Section II of III

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 11100.FM.A Section II of III

31. 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. “Request to Create a New Clinical Study in GE/IDX” Form 11100.FM.A Section III– To be completed by YSM Financial Business Office

32. “Request to Create a New Clinical Study in GE/IDX” Form 11100.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 ymgstudycases@yale.edu You can find a PDF copy of this form to print out at this URL: http://www.yalemedicalgroup.org/comply/alert/formtrain/NewStudyRequest.pdf

33. Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX 11100.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, emailing 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.

34. 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. Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX 11100.FM.B Section I of II

35. HIC # - Human Investigation Committee approval number. Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX 11100.FM.B Section I of II

36. Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX 11100.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.

37. Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX 11100.FM.B Section I of II Contact’s Phone - Employee’s phone number designated by the clinical department to enroll, Term/Complete patients.

38. Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX 11100.FM.B Section I of II Contacts Email - Employee’s email designated by the clinical department to enroll, Term/Complete patients.

39. 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. Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX 11100.FM.B Section II

40. Enroll – Check if enrolling a patient. Not eligible-ex: (screen failure ) Check if the patient did not meet the eligibility criteria. Terminated / completed – Check if terminating or completing a patient. Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX 11100.FM.B Section II

41. 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. Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX 11100.FM.B Section II

42. End Date – the date the patient was Terminated/completed in a research study. Effective date – the date the patient was enrolled in a research study. Notification of Patient Enrollment/Term/Complete in a Clinical Study in GE/IDX 11100.FM.B Section II

43. 11100.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 and faxed to Fax: 785-6975 Or Saved and emailed as an attachment to: ymgstudycases@yale.edu

44. You can find a PDF copy of this form to print out at this URL: http://www.yalemedicalgroup.org/pfs/forms/10000/PatientEnroll.pdf

45. How to receive credit for this tutorial If you have accessed this presentation through the TMS training page located at http://www/yale.edu/training 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

46. Another way is to use the attestation, print it off and fax or mail it to the Compliance Department: Attention: Tony Fusco at 737-5785 To print off a paper copy of the attestation, click here http://www.yalemedicalgroup.org/comply/alert/formtrain/PDFAttestation.pdf To fill out and submit attestation by email, click here http://www.yalemedicalgroup.org/comply/alert/formtrain/Researchformattest.htm Thank you for completing this training!