Document alignment review

When clinical research studies are submitted to the OCR for entry into OnCore, a coverage analyst is assigned to perform a document alignment review, which compares the language in essential study documents for consistency. These essential study documents include the study protocol, informed consent documents, and the contract and budget documents, when applicable. When reviewing these documents, the coverage analyst is primarily looking for consistency in financial responsibility and cost language and ensuring that the language does not violate University guidelines or federal regulations regarding clinical research billing.

The initial review of these documents should be performed while they are still in draft status. This allows for revisions to be made without having to process an amendment to the consent or contract documents. The assigned coverage analyst will work with the study team if inconsistencies are identified in the initial review. When the essential documents have been finalized, the coverage analyst will perform a final review to ensure that issues have been resolved and documents are aligned in their final versions. The following items are of primary concern for our coverage analysts as they complete the document alignment:

    1. Are procedures clearly and consistently designated as sponsor paid or billable to the patient within the coverage analysis, contract, budget and informed consent form (ICF)?
    2. Are additional costs to the patient clearly identified in the ICF?
    3. Is participant compensation consistent across the contract, budget and ICF?
    4. Does the contract, budget or ICF contain any language that may violate the Medicare Secondary Payer policy? Is there conditional payment language?
    5. Has responsibility for subject injury been appropriately assigned and is it consistent between the contract and ICF?