All clinical research, regardless of funding source (including clinical research that does not have an external funding source) must be submitted to the Center for Clinical Trials for review prior to beginning a study. This requirement has been effective since December 1, 2008.
Preliminary Medicare Coverage and Billing Analysis
Clinical Research that Requires CCT Review
- All clinical research that includes clinical care activity regardless of funding source including federal, state, foundation, external hospital or university funding
- All unfunded or internally funded clinical research that includes clinical care activity
- All commercially funded clinical research that includes clinical care activity
Clinical Research that DOES NOT Require CCT Review
- Retrospective studies that evaluate events that have already occurred including studies that rely exclusively on previously collected administrative records, medical data or other available data
- Survey studies that do not include clinical care activities
- Laboratory analysis studies utilizing human tissue samples obtained from another entity that do not include additional clinical care activity
How and When To Send a Protocol for PMCA/Billing Analysis Review
A CCT Clinical Research Review Request Form must be completed and sent to CCT for the types of clinical research studies described above that require review. This is the same form currently used for commercially funded clinical research review. The request form should be completed a few weeks prior to IRB submission or at the same time the IRB application is submitted in draft to the IRB.
Grant Proposals
CCT can assist faculty investigators determine clinical care cost estimates and potential Medicare coverage of protocol-driven clinical care, to help ensure budgets submitted to funding agencies include a request for sufficient funds to cover the cost of non-billable clinical care. The development of the proposed grant budget will continue to be the responsibility of the investigator and department.