Prior to participant enrollment, the hospital involved in the study – Stanford Health Care (SHC) and/or Lucile Packard Children’s Hospital (LPCH) – must create a research study account or accounts to ensure proper billing.
The study coordinator completes the Study Account Request form in the Budget and Billing Workbook and submits the entire workbook to Patient Financial Services (PFS) at SHC and/or LPCH. PFS creates the appropriate hospital account(s) so that charges can be billed correctly to the research study with the negotiated research discounts.
How to Secure All Regulatory Approvals
The study Principal Investigator (PI) or study coordinator emails the Budget and Billing Workbook containing the completed Study Account Request Form to the PFS contact named on the form. PFS needs at least seven (7) working days to set up the account prior to enrolling the first participant. Hospital account set-up requires a University PTA (Project Task Award) and a study National Clinical Trial (NCT) registry number from ClinicalTrials.gov. If the study does not have an NCT number, enter “N/A” in the data field.
PFS creates a 98, 99 and/or mnemonic account and returns the workbook(s) with the account information to the study coordinator.
At the time of consent, the study coordinator enters participant information into the Study Enrollment Form in the Budget and Billing Workbook and then emails the workbook to PFS. After a participant receives hospital services, PFS bills the charges to the patient insurance and/or research account according to the Research Participant Services (RPS) Form.
Study participants treated at LPCH and/or LPCH clinics must complete the LPCH Patient Registration/Admitting Letter at each study visit.
Study Account Types
- 98 account, used when some or all patient services are billed to the study account
- 99 account, used when all patient services are billed to the patient and/or patient insurance
- mnemonic (also known as client) account
- DO NOT enroll participants in a study prior to receiving a 98/99 and/or mnemonic research study account or participants will be billed for all charges. The hospital relies upon the study team to follow the process to ensure Medicare and other insurers are not billed fraudulently.
- Prior to the study participant receiving any research services, the study coordinator must enter the participant’s information on theStudy Enrollment Form, including a start and stop date, and submit the Budget and Billing Workbook to PFS. DO NOT indicate an END date until the participant is completely off the study and all study visits have occured. Be sure to submit the names of participants who are screen failures otherwise the participant (or insurance) will be billed (i.e., screening labs).
- Email the entire workbook back to PFS with "SECURE:" typed in subject line (see form for email address).
- Email entire workbook to PFS each time a new participant is enrolled in the study or if participant is off study prior to any services being performed. This is the ONLY way PFS knows that a new participant is taking part in a research study.
- The Budget and Billing Workbook should only be used for out-patient studies. If the SHC study involves an in-patient admission and/or out-patient surgery/procedure, complete one SHC Clinical Trial Registration Form (CTRF) per study participant. Either the entire service or partial services are billed to the study.