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
Required UTSW IRB Review
You must submit all research involving human subjects for review and approval to the UTSW Institutional Review Board (IRB).
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.
How to Submit Coverage Analysis Documents
You can submit your Coverage Analysis (CA) documents through the Velos system once your IRB application is complete or in draft. To begin the CA process, submit the following required documents:
- Consent draft
- Budget draft, if available
- Investigational New Drug (IND) letter, if applicable
- 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
- IRB application draft
- 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. 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.
- 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.
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.
- 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
- 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 International Classification of Functioning (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.
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Inquiries reviewed and assigned within 4 hours, Monday – Friday 8 a.m. – 5 p.m.
Julia Spesivtseva, MBA, CIP, CRCP
Director, Clinical Research Services
Mary Jo Cascardo
Manager, Coverage Analysis
Manager, Industry Contracts
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