1. When should I enroll people in a study?
Participants need to be enrolled in a study within one business day after they sign the Informed Consent.
2. What is the Date of Last Clinical Service?
The Date of Last Clinical Service is when your participant is finished with all protocol directed services. If, for example, your study timeline has a 30 day visit and then phone follow-ups for 5 years, then this participant’s Date of Last Clinical Service should be entered as the date of the 30 day visit.
3. I have a study where all the procedures are performed on the same day. How do I enter the dates?
In this instance the Consent Date, the Date of First Clinical Service, and the Date of Last Clinical Service would be the same date.
4. Are there any studies for which it is not necessary to enter participants?
Yes. There are a few scenarios for which this requirement is waived. A decision tree that covers most of these scenarios has been created and is posted on the Billing Matrix page. If you are questioning whether subjects need to be enrolled, you can consult this decision tree and contact the Clinical Research Billing Support office at email@example.com.The Clinical Research Billing Support office makes this decision.
5. I tried to change something on the Matrix and can’t do it, what’s wrong?
You are allowed to view only the Matrix and the Profile page. If you believe something is incorrect in the Matrix or the Profile section, and needs to be altered, please contact the Matrix team at firstname.lastname@example.org. We will discuss it and if needed, we can make the change.
6. I have been asked to retrieve participant information on a closed study. This addresses the billing needs, but would I be HRPO non-compliant by looking at study data when the study is IRB closed?
No. This is not a HRPO/research violation as providing this information is a necessary University function.
7. We don’t currently have IRB approval to collect SSN numbers and it is my experience that many healthy volunteers for studies won’t want to provide their SSN numbers. Is SSN is required?
You do not need additional IRB approval. The informed consent form has been approved by the IRB and addresses the use of such personal information. The HIPAA section in the consent discusses the types of access, use and disclosure of a participant’s protected health information or personal information in the study. It specifically states, in part, that:
“The research team will follow state and federal laws and may share your information with:
- Government representatives, (including the Office for Human Research Protections or the Food and Drug Administration) to complete federal or state responsibilities
- Hospital or University representatives, to complete Hospital or University responsibilities
- Your primary care physician if a medical condition that needs urgent attention is discovered
- Once your health information is shared with someone outside of the research team, it may no longer be protected by HIPAA.”
We would like you to request the last 4 numbers of the SSN, but if the participant refuses, document that somewhere, and then enroll them without the numbers.
8. What does “engaged” member of the study team mean?
An individual is “engaged in human subject research” if s/he has contact or interactions with human research participants or research data involving human participants. The HRPO submission form requests the names of engaged members of the study team.
9. Why are you asking for the budget?
We are requesting a copy of the budget to find out which services and procedures are intended to be paid for by the study sponsor. We want to be able to provide, if audited, not only the rationale behind our designations of INV or SOC, but justification that we are not double billing for any services. We do not need to see salaries or dollar amounts for procedures, but it would be helpful to know the facility and the location where the procedure will take place (e.g., the imaging scan will be done at CCIR, BJH Radiology department or the East Building), and who is paying for it.
Contacts for the Billing Matrix
Billing Matrix Administrative Professional
Assistant Dean Clinical Studies