Using the Subject Billing Registry

1. Using the Subject Billing Registry What, When, and How-To

2. What is the Subject Billing Registry? The Subject Billing Registry is a user-friendly program designed to capture information on subjects enrolled in clinical trials for which bills are generated here at Duke from September 2000 to the present.

3. What Studies Require Subject Entry in the Subject Billing Registry? Those studies that require an approved Charge Assignment Grid are required to have all subjects, including healthy controls, entered in the Subject Billing Registry. While not mandatory, Site Based Research Units, or Study Teams may choose to include other studies in the Subject Billing Registry.

4. Are there any Exceptions? YES 1. Studies that require Cancer Protocol Committee (CPC) approval have an automated entry process. Subjects may either be entered into the e-Research system by the study team OR a Patient Registration Form must be filled out and sent to the Oncology SBR. 2. Any exceptions for confidentiality reasons must be approved by the CRSO Medical Director, Dr. Lynda Szczech. If granted, enrollment logs must be submitted to the CRSO electronically or by fax every time information contained on the enrollment log changes.

5. When Must Subject Data Be Entered in the Subject Billing Registry? A subject must be entered in the Subject Billing Registry within 1 business day of providing Informed Consent. (This is most often documented by signature on a Consent Form). Screen failures must be included in the Subject Billing Registry. Also, within 1 business day of the end of billing activity, subject data should be entered in the Subject Billing Registry to update subject status for billing purposes.

6. Where is the Subject Billing Registry Located? The Subject Billing Registry is located at: https://slytherin.duhs.duke.edu/crso/registry.nsf/login However, the Subject Billing Registry is also easily reached by the Quick Link on the CRSO website: http://crso.som.duke.edu

7. Logging In to the Subject Billing Registry Log in using your PIN account. If you do not have a PIN account, contact the DHTS HelpDesk (helpdesk@mc.duke.edu). Additional directions are provided on this login page.

8. Searching the Subject Billing Registry To search for a Subject, you can use an MRN number, a Name, or an IRB Number. To search for an IRB, you can use the IRB Number, the Study Title, or the PI Name.

9. Entering a Subject in the Subject Billing Registry After logging in to the Subject Billing Registry, click the “Register Subject” button.

10. Entering a Subject in the Subject Billing Registry You will need three pieces of information to register a subject: • The Study’s IRB# • The Subject’s Medical Record Number (MRN) • The Date of the Subject’s Consent

11. Entering a Subject in the Subject Billing Registry 1. IRB Number. If it is an eIRB number, type all 8 digits after the “Pro” (ie. 00001234, not Pro00001234). And, if the study has an old IRB number, type just the first 4 digits (ie. 1234, not 1234-05-R3).

12. Entering a Subject in the Subject Billing Registry 2. MRN Number. Choose the appropriate hospital. Then, type the MRN number. Click the “Lookup” button. Be sure that the correct patient name and demographics pop up.

13. Entering a Subject in the Subject Billing Registry 3. Date of Consent. Click the calendar icon below the data field. Choose the date the subject consented. That date will automatically appear in the data field. Then, click “Save”!

14. Entering Additional Subject Data • When a subject’s billing period ends, that date should be added within 1 business day. • First, find the subject in the Subject Billing Registry by using the SEARCH function. • Click on the Subject’s name. Then, click on the “Edit” button.

15. Entering Additional Subject Data • 3. Enter the end billing date. • 4. Then, click “Save”.

16. What to do in the Event of an Error Please contact the CRSO immediately if a subject is entered into the Subject Billing Registry in error, or if you encounter any difficulties using the system. You can reach the CRSO at: CRSO.Help@notes.duke.edu OR 681-6665