Hospital Study Accounts

Study teams obtain the Final Workbook by email from their CT RPM or SCI-CTO Financial Specialist. NOTE: Submitting older draft versions of workbooks to conduct study may cause critical billing compliancc issues.

The study team is responsible to email the Final CA Workbook and/or the SHC 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 CA 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 Coverage Analysis Billing Grid.

After consenting and prior to the study participant receiving any research services, including ALL screening procedures, the study coordinator must enter the participant’s information on the Study 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.

Email the entire workbook back to PFS with "SECURE:" typed in subject line (see instructions tab 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 CA 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) downloaded from Spectrum website per study participant. Either the entire service or partial services are billed to the study.

Please access Clinical Research Support Office (CRSO) Epic Tipsheets.

SHC

• 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

LPCH

• 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.

Be sure to submit the names of participants who are screen failures otherwise the participant (or insurance) will be billed (i.e., screening labs).