Review Study

Review Award Image hand with pen opening document

Summary

Review Study consists of:

Coverage Analysis (CA) - a systematic review that examines clinical trial protocols and determines the items and services to be billed to the study sponsor or the insurance company
Internal review of industry clinical research agreements

Estimated Duration

The duration of contract reviews varies based on your sponsor, agreement, or contract type.

How to Begin Coverage Analysis

Please adhere to the following steps for the Coverage Analysis of your study. These tasks may be completed in parallel when appropriate.

Manage all updates and results on clinicaltrials.gov.
Register your study in Velos.
Register your study with IRB.
Request a Coverage Analysis from SPA’s Coverage Analysis.
Review Coverage Analysis and request changes if applicable.
Negotiate your final budget with sponsor.
Approve Coverage Analysis in DocuSign.
Approve Coverage Analysis modifications in DocuSign, if applicable.
Medicare Coverage Analysis Review Fees

How to Submit Coverage Analysis

Coverage Analysis (CA) documents must be submitted either through the Velos system or loaded into the eIRB system. To begin the CA process, the following information is required. In the event the below listed documents are not submitted at the time of the CA submission, it may result in an administrative withdrawal.

CA request via the “Coverage Analysis- Submitted" study status in Velos
Protocol (loaded either in eIRB or in Velos)
IRB application (in draft or completed state)
Consent draft (loaded either in eIRB or in Velos)
Budget draft (required for industry funded studies. Can be loaded in Velos or emailed to CoverageAnalysis@UTSouthwestern.edu). Final budget will be required at the time of the CA Congruency.
Funding Sheet, Internal Budget or a Budget Justification Document, Statement of Work (or similar) for non-industry funded studies to be submitted, if available and applicable at the CA submission timepoint. If not, this will be required at the time of the CA Congruency.
FDA Investigational New Drug (IND) letter, if applicable
FDA Investigational Device Exemption IDE letter, if applicable
Centers for Medicare & Medicaid Services (CMS) IDE approval letter, if billing to Medicare will be done on a research device
ClinicalTrials.gov Registration Number (NCT) number
Complete draft Performance Site Review form (PSF for UT Southwestern must have sections 3: Location, 4: Clinical Laboratory Services, 5: Radiology, 7: Clinical Research Unit [CRU] if applicable)
Departmentally funded studies - Chart of Account (COA) should be added to the Velos Summary tab
Lab and imagining manuals, if applicable (loaded in Velos Documents Tab)
Supporting documentation, such as regulatory support or peer-reviewed articles to assist with coverage determination, if applicable

When to Submit Coverage Analysis

Coverage Analysis must be submitted at the same time as the IRB and/or contract submission is completed, but before IRB issues approval
If submission is not completed prior to IRB approval, there will be an automatic submission generated by the Velos system
If CA request is not submitted in a timely manner, eIRB Greenlight will be delayed, pending final CA determination

Draft CA document is released through DocuSign prior to being final in order to assist with budget preparation.

Once the coverage analysis draft is available in Velos, you can locate the draft under the Documents tab.

How to Submit Your Industry Clinical Research Agreement

You can submit your contract through the eAgreements system simultaneously as the IRB full or partial application is completed. However, you may submit a contract review request before submitting your IRB application, but it at least needs to be in "Draft State."

For step-by-step assistance with submission of your agreement, by contract type, please reference the following guidance materials:

To begin the contract review process, submit the following required documents:

Sponsor agreement template draft
Coverage analysis draft submitted in Velos
Consent document draft (either in eAgreements or eIRB)
Protocol draft (either in eAgreements or eIRB)
Budget draft (final budget if Statement of Work (SOW) is being submitted)
IRB application draft

Terms and Definitions

Coverage Analysis (CA): A systematic review that examines clinical trial protocols and determines what to bill to the study sponsor or the insurance company.
Center for Medicare and Medicaid Services (CMS): A federal agency that works with states to operate the Medicaid program and ensure beneficiaries get high-quality health care.
Industry-Sponsored Clinical Trial: A research study that assesses the safety and efficacy in humans of a drug, device, diagnostic, treatment, preventive measure, or similar intervention through testing of the intervention on patients in a clinical setting.
Investigational Device Exemption (IDE): Exemption from certain Medical Device Amendment regulations that allows shipment of unapproved devices across state lines for use in clinical investigations.
Investigational New Drug (IND): Application submitted to the Food and Drug Administration (FDA) for permission to conduct a clinical study using a drug or biologic that is new or not approved for a given dosage, formulation, route, or indication.

View All Terms & Definitions

Expert Tips

Centers for Medicare and Medicaid Services (CMS)

What does the Centers for Medicare and Medicaid Services (CMS) regulate?

The CMS oversees the nation’s primary health care programs such as Medicare, Medicaid, and Children's Health Insurance Program (CHIP).

They collect and analyze data, produce research reports, and work to eliminate instances of fraud and abuse within the health care system.

The agency strives to provide a health care system with better care, access to coverage, and improved health.

Visit CMS.gov
ClinicalTrials.gov
ClinicalTrials.gov provides patients, family members, health care professionals, researchers, and the public with easy access to publicly and privately supported clinical studies on a wide range of diseases and conditions.

When you submit your study to SPA for review, you will need to provide a ClinicalTrials.gov (NCT) number for billing purposes.

Available Resources:
- Disease or condition
- Intervention (e.g., the medical product, behavior, or procedure being studied)
- Title, description, and design of the study
- Requirements for participation (eligibility criteria)
- Locations where the study is being conducted
- Contact information for the study locations
Visit ClinicalTrials.gov
Coverage Analysis
How do I request a Coverage Analysis (CA)?
You will need to follow the steps outlined in the Velos Coverage Analysis Submission document to ensure that you submit your study accurately for review.

How do I submit a Coverage Analysis modification?
You will need to follow the steps outlined in the Velos Coverage Analysis Modification document to ensure that you submit your modifications accurately.

How do I find research pricing for a service or procedure?
You can research pricing by going to the Velos library. Choose the appropriate rate list (depending on funding and facility) and use the search function with description or Current Procedural Terminology (CPT) code.

If my PI says a treatment is routine or standard of care, does that mean it is considered automatically reimbursable by CMS/Medicare?
No, SPA will follow conventional care and Medicare guidelines to determine which method we will take.

What is a Congruency Review?
A congruency review is a side-by-side comparison of the budget portion of a proposal (grant, contract, subaward, etc.) and consent form.

Congruency Review FAQs

What should I do if my study has been administratively withdrawn prior to having a final budget?
You should continue to upload your budget into eAgreements. Once you submit a finalized budget, you will need to log in to Velos and select status: Study – Final Budget Complete. The Central Coverage Analysis Group (CCAG) will review the CA draft against the final budget and informed consent form and amend CA to match.
- If all items match, the CCAG team will provide the final CA via DocuSign.
- If we require adjustments to the Informed Consent Form (ICF) or budget, the CCAG team will send the CA back through Velos with specific instructions, using Coverage Analysis – Congruency Corrections Pending
Industry Clinical Research Agreements

Who processes Industry Clinical Research Agreements?
The Industry-Sponsored Clinical Trial Team handles any human research agreement with industry funding. Contact the Industry Agreement team for further assistance.

Who signs the Industry Clinical Research Agreement?
It depends on the total budget amount. Please reference the Institutional Signature Matrix for guidance.

Who negotiates the agreement budget?
Budgets are negotiated directly by the Department. Please reach out to the Clinical Trials Accounting team within SPA for additional assistance.

How are agreements submitted to SPA?
You can submit your agreement to SPA through eAgreements. Please reference the eAgreements Submission Guide for further instructions.

Does my agreement need to be submitted to SPA?
If your study conducts human research, you will need to submit an agreement to SPA for review and negotiations. PIs and Department Chairs do not have the authority to sign on behalf of the institution. If you are unsure whether your study conducts human research, please contact SPA by submitting a ServiceNow ticket.