Public Service Announcements!
- If my study only involves a research blood draw and no other items or services, should I still create a billing calendar?
- Dis-enrolling subject in MBECT is important because:
- Reduces clinical research billing errors
- Makes data in MBECT and MiChart more reliable
- Reduces Research Work Queue workload-faster routing of charges
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Clinical Research Billing and Coding
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Please be sure that when ordering in MiChart you are ordering the same CPT code that is included on your billing calendar. This will ensure that your enrolled subject gets stopped in the research work queue for review of charges. Labs continue to be the most common billing issues. For example: If you have a subject that comes in and a CBC with Platelets and Differential (CPT 85025) is ordered, but CBC with Platelets (CPT 85027) is on the billing calendar, this may not get routed properly. We are working diligently with RCRB to make sure these are caught but please keep this in mind when ordering services. |
IRBMED working with Central IRBs
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U-M has begun working with several central IRBs to cede regulatory oversight of certain eligible research studies. U-M currently has service agreements with: Chesapeake IRB, Western IRB, Schulman Associates IRB, Quorum Review, and NCI CIRB. Ceding of oversight to a central IRB is currently limited to phases III and IV, multi-site, industry-sponsored research, where the central IRB will provide the project oversight and U-M will be added on as a performance site or for NCI-CIRB clinical trials (all phases).
Although the project will be under the primary oversight of the external IRB, the project must be submitted in the eResearch system through the application type (Section 1-1.1) entitled Requesting Review by a Non-U-M IRB. The application will still be reviewed by IRBMED and any applicable ancillary committees for the local context review with an acknowledgement issued.
When a Ceding application is submitted in eResearch, IRBMED will receive an early alert. As the application is routed through the standard Ancillary Committee(s) review and approval process, IRBMED will perform concurrent review. Once all reviews are complete, IRBMED will issue an acknowledgement indicating that U-M initial review is complete and that oversight may be ceded.
Ancillary review of Ceding applications remains unchanged. If you receive questions about this process, please feel free to refer them to IRBMED.
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